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New Study Shows That CPAP and Oral Appliance Therapy Come Out Even Par, When Used Equal Amount of Time

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Gergen's Orthodontic Lab Sleep Herbst
Gergen’s Orthodontic Lab Sleep Herbst

Maria De Lourdes Rabelo Guimarães and Ana Paula Hermont1

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This article has been cited by other articles in PMC.

Abstract

Background:

Dental practitioners have a key role in the quality of life and prevention of occupational accidents of workers with Obstructive Sleep Apnea Syndrome (OSAS).

Aim:

The aim of this study was to review the impact of OSAS, the Continuous Positive Airway Pressure (CPAP) therapy, and the evidence regarding the use of oral appliances (OA) on the health and safety of workers.

Materials and Methods:

Searches were conducted in MEDLINE (PubMed), Lilacs and Sci ELO. Articles published from January 1980 to June 2014 were included.

Results:

The research retrieved 2188 articles and 99 met the inclusion criteria. An increase in occupational accidents due to reduced vigilance and attention in snorers and patients with OSAS was observed. Such involvements were related to excessive daytime sleepiness and neurocognitive function impairments. The use of OA are less effective when compared with CPAP, but the results related to excessive sleepiness and cognitive performance showed improvements similar to CPAP. Treatments with OA showed greater patient compliance than the CPAP therapy.

Conclusion:

OSAS is a prevalent disorder among workers, leads to increased risk of occupational accidents, and has a significant impact on the economy. The CPAP therapy reduces the risk of occupational accidents. The OA can improve the work performance; but there is no scientific evidence associating its use with occupational accidents reduction. Future research should focus on determining the cost-effectiveness of OA as well as its influence and efficacy in preventing occupational accidents.

Keywords: Continuous positive air pressure, obstructive sleep apnea, occupational accidents, oral appliances, review

INTRODUCTION

The Obstructive Sleep Apnea Syndrome (OSAS) is characterized by repeated collapse of the upper airway during sleep, resulting in nocturnal hypoxemia and fragmented sleep. Associated brain dysfunctions can be expressed, such as abnormal daytime sleepiness and lack of concentration, and these are common causes of traffic accidents.[1,2,3,4]

Several studies have associated OSAS with increased risk of traffic accidents[4,5] and the majority of the researches were conducted among professional drivers. Obtaining data on the frequency of sleep-disordered breathing, nocturnal sleep disruption, and excessive sleepiness among the working population is an important public health problem.[6,7] It is noteworthy that the identification and treatment of snoring and OSAS in workers can potentially reduce the number of occupational injuries, absenteeism, improve productivity, health, and wellbeing of these professionals.[8,9,10,11]

Several well-tolerated and effective treatments for OSAS have demonstrated improvements in the quality of life and reduction in the use of health services and vehicle collisions.[12,13,14] Treatments for OSAS can be clinical or surgical, and the clinical treatment options include behavioral measures, and the use of continuous positive airway pressure device (CPAP) or oral appliances (OA).[15]

The OA are a noninvasive treatment option for patients with OSAS and it is considered less uncomfortable than CPAP.[16] The American Academy of Sleep Medicine recommends the OA therapy for patients with mild-to-moderate OSAS and those with severe OSAS who cannot tolerate CPAP and refuse surgery procedures.[17]

The use of CPAP is indicated as firstline treatment for people with high levels of apnea-hypopnea index (AHI) associated with excessive sleepiness[18] ; however, there are indications that OA improves subjective sleepiness and sleep-disordered breathing.[19]

Randomized trials assessing the effectiveness of OA found that it reduced the excessive daytime sleepiness when compared with patients without treatment.[20,21,22,23,24] Moreover, when the results of CPAP and OA were compared, there was no significant difference between both therapies.[25,26,27,28,30]

A randomized clinical trial presented improvements on energy and fatigue levels and vigilance and psychomotor speed among patients treated with OA when compared with placebo.[20] Other studies also found improvements in neurocognitive function using the OA, which did not differ statistically from the improvements achieved by the CPAP therapy.[26,27]

In 2011, a longitudinal study was conducted with patients with mild-to-moderate OSAS who were randomized regarding the treatment for CPAP or OA. The study showed similar improvement from both therapies regarding the AHI and excessive daytime sleepiness; however, the survey sample was not representative.[31] It is worth noticing that changes in the oral appliances design may contribute to different results, once a study comparing devices with different designs showed differences in the improvement of excessive daytime sleepiness.[32]

The CPAP treatment significantly reduces the risk of accidents in OSAS patients.[33,34,35,36,37] Treatment with OA, in addition to being effective to normalize the respiratory disorders, improved work performance of patients with OSAS.[38] However, it still lacks a more comprehensive way to assess the benefit of OA on driving simulation and real driving performance.[14] This article aimed to revise the prevalence and impact of OSA on work performance, occupational impairments, use of health services, and its economic impact. The cost-effectiveness and effects of the CPAP therapy and especially the role of OA concerning those issues were also investigated.

MATERIALS AND METHODS

These were the inclusion criteria used in this article: Articles published from January 1980 to June 2014 concerning patients with a diagnosis of OSA, presenting AHI >5, snorers, upper airway resistance syndrome, age ≥18 years; any study design and the languages were restricted to: English, French, and Portuguese.

Exclusion criteria were central sleep apnea, coexisting sleep disorders, regular use of sedatives or narcotics, preexisting lung disease, and psychiatric illness. Searches were conducted on MEDLINE (PubMed), Latin American and Caribbean Literature Data on Health Sciences (LILACS) and Scientific Electronic Library Online (SciELO), in addition to searches from the references of the identified articles.

The search strategy was performed by combining the following descriptors: Apnea, snoring, sleepiness, mandibular advancement devices, oral appliances, continuous positive air pressure, cost, economics, cost-effectiveness, accident, health care utilization, driving, occupational accidents, occupational injury, traffic, commercial vehicle drivers, and work limitation. The analysis was based on critical readings of the articles content. Subsequently, the common contents were identified, grouped, and tabulated to form the thematic analysis and preparation of a critical discourse.

RESULTS AND DISCUSSION

During the search, 2188 articles were identified, but 2095 were excluded once they did not meet the inclusion criteria, totaling 99 articles included.

Impairments in occupational performance

Sleepiness negatively affects cognitive function, therefore it is assumed that patients with OSAS suffer impairments in labor capacity,[9,39,40,41] by presenting lack of concentration and attention, memory impairment, and changes in the ability to perform everyday tasks and learning. Moreover, the reduced capacity for executive functions such as completing tasks, can cause loss of motivation and initiative.[9,42]

The National Sleep Foundations (NSF) in the United States assessed the sleep of workers and found that those at risk for OSAS had a greater chance of having difficulty when performing cognitive tasks, including problems with concentration and organization and also a greater risk of falling asleep at work, decreased productivity, and absenteeism due to sleepiness.[43] Snoring was also highly associated with excessive sleepiness and work performance impairments.[44]

The sleep-disordered breathing was a common finding among Brazilian professional drivers who presented an OSAS prevalence of 38%. Furthermore, the daytime sleep was fragmented and shorter than nocturnal sleep and more drivers presented extreme sleepiness. It is worth noticing that such deficiencies of sleep can negatively affect performance in driving.[45] Another epidemiological study conducted among Brazilian railroad workers suggested age, body mass index (BMI), and alcohol consumption as associated with an increased risk of developing OSAS and it stressed the need for greater attention to this population, once they are more prone to suffer accidents.[46]

In Greece, the prevalence of sleep-disordered breathing among drivers of rail transport was similar to other studies, but the study reported a low prevalence of drowsy drivers (7.1%). However, this data has to be carefully analyzed once it was used a subjective evaluation criterion by Epworth Sleepiness Scale.[47]

Among a group of American officers, sleep disorder was identified as an ordinary problem and that it was significantly associated with increased risk of health problems, work performance, and safety outcomes; OSAS was the most prevalent disorder (33.6%). Excessive sleepiness was found in 28.5% of the police officers and there was an increase in the prevalence of physical and mental health disorders, including diabetes, depression, cardiovascular disease, and increased risk of accidents.[48]

A study carried out among soldiers identified that 88.2% of the sample were diagnosed with sleep disorders. Insomnia coexisting with OSAS was found in 38.2% of the military and they were significantly more likely to meet criteria for depression compared with control subjects and others with only OSAS.[49] Among young soldiers in Korea, it was found that the prevalence of snoring and high risk of OSAS was 13.5% and 8.1%, respectively. It is worth noticing that this is not a low prevalence considering that the individuals were young and not obese.[50]

It was observed that the treatment of OSAS resulted in the reduction of occupational accidents and improved the performance of employees. Therefore, it is advisable to develop strategies for screening effective treatment of OSAS.[51] Nevertheless, it has been difficult to establish the exact effect of untreated OSAS in real driving and traffic accidents. Driving simulators have been used as a cheaper and safer reproducible way to assess the effect of OSAS on different aspects of driving, but despite the benefits provided, the simulator cannot measure all the aspects experienced in a real-life driving situation.[52]

In Canada, useful data from a study of driving in “real life” were evaluated. Over a period of three years patients with mild, moderate, and severe OSAS had an increased rate of traffic accidents when compared with drivers without this condition and had higher rates of road traffic accidents associated with personal injury.[53] Worse performances in driving simulators among subjects with untreated OSAS was also identified by other studies.[54,55,56] Nonetheless, after treatment with CPAP, there was an improvement in the driving performance.[36,54,55] It is known that the CPAP therapy improves driving performance and can potentially reduce the risk of accidents, but the benefits provided by CPAP depend on treatment adherence.[57]

The results of a study conducted in 2011 suggest persistent impairment in driving simulator during long trips in patients with severe OSAS treated with CPAP. These results support the evidence that some neurobehavioral deficits in patients with severe OSA are not fully reversed by treatment. More controlled studies with larger samples are needed to confirm these findings and further researches should investigate the causes of residual driving simulator impairment among patients with OSAS treated with CPAP and its association with increased risk of vehicular accident on highway.[57]

Test driving simulator was also used to investigate whether OSAS patients had worse labor performance than healthy drivers. The benefits provided by OA and CPAP were also analyzed. The results showed a significantly higher number of lapses in attention among OSAS patients. The total number of lapses of attention was significantly decreased after both therapies, with OA and CPAP, with no significant differences between the two types of treatment.[25]

However, a more comprehensive way to assess the benefits of OA on driving simulation tests, and real-life driving performance are needed to adequately assess its potential role concerning the risk of drowsiness at the wheel represented by OSA.[14]

Another important issue that should be discussed concerning the impairments in occupational performance is related to the international driving licensing legislation. A committee established by the European Commission on sleep apnea and driving has been discussing about directives with an approach to patients with moderate or severe sleep apnea, particularly associated with significant sleepiness. Those patients will be prevented from driving, or at least will be prevented from holding a driver’s license, until the condition is successfully treated.[58]

The driving licenses may be issued to applicants or drivers with moderate or severe OSAS who show adequate control of their condition and compliance with appropriate treatment and improvement of sleepiness, if any, confirmed by authorized medical opinion. Applicants or drivers with moderate or severe OSAS under treatment shall be subject to a periodic medical review with a view to establish the level of compliance with the treatment, the continued good vigilance, and evaluate the need for continuing the treatment.[58]

Occupational injury

Many mental functions are reduced in situations of fatigue and sleepiness.[59] It is estimated that 20% of accidents are caused by drivers’ inattention and sleepiness,[60] and the occurrence of drowsiness when driving is a major risk factor for dangerous accidents.[61] Chronic excessive sleepiness and sleep-disordered breathing were common in a sample of drivers of commercial vehicles in Australia. Sixty percent of drivers had OSAS and 16% had OSAS with excessive daytime sleepiness.[62] Drivers with a high risk for OSAS and a work schedule with little chance of rest reported more daytime sleepiness and poor sleep quality in a study conducted among Belgian truckers[63] and Japanese bus drivers.[64]

In Brazil, 16% of professional drivers admitted having fallen asleep at the wheel; however, this number increased to 58% when it was reported by colleagues. It was observed that respiratory disorders and snoring are some causes of fragmentation or reduction of rapid eye movement (REM) sleep, which could support the hypothesis that REM sleep deprivation can lead to common complaints such as mental fatigue, irritability, and sleepiness among professional drivers.[65]

Nowadays, most European countries have traffic laws directed to sleep-disordered breathing.[7] The driver screening methods should contain questions about drowsiness at the wheel, habitual snoring, and sleep apneas, as well as the Epworth Index and BMI.[7] After an assuredly effective and efficient treatment, including regular checkups for control and evaluation of symptoms, patients are allowed to drive. Nevertheless, during the interim period between the diagnosis and therapy, drivers can still be considered able to drive, but with limitations (eg, drive short distances and avoid driving on major highways or at night.[7,66]

In Brazil, due to the high rate of traffic accidents caused by drowsiness, in 2008, a resolution was approved by the National Traffic Department to reduce the number of accidents caused by drowsiness, fatigue, sleep-disordered breathing, and changes in biological rhythms.[59] Evaluation of OSA was included in this resolution as well as the requirement of new medical and psychological examinations for all professional drivers.[59]

Sleep-related accidents comprise 16%-23% of all vehicle accidents.[67] Many of these accidents could be prevented by treating sleep-disordered breathing.[68] However, drivers with symptoms of drowsiness or sleep-disordered breathing may not report accidents due to concerns of losing their jobs, compromising the results of studies on the association between these disorders and accidents.[62]

A study conducted among long distance truck drivers in the United States found that about 20% of drivers presented symptoms of sleep disorders. Drivers who were working with the same company for over a year were more likely to have daytime fatigue, daytime tiredness, restless sleep, hypertension, and increased BMI.[6] Other studies observed a higher prevalence of OSAS in railway workers than in the general population,[46,47] thus necessitating greater attention to this population, due to the greater propensity for accidents.

A research conducted with presumably healthy working men also identified a significant association between the complaint of excessive daytime sleepiness and the incidence of sleep apnea.[69] In Turkey, 241 long-distance drivers were interviewed about symptoms of OSAS, and occupational history. The drivers who had evidence of OSAS underwent polysomnography. Snoring was detected in 56% of all participants and daytime sleepiness was observed in 26.6%. The prevalence of OSAS was 14.1%. There was a significant relationship between the rate of traffic accidents by professionals/year and AHI, lowest saturation, desaturation index, and arousal index. The disease severity was directly proportional to the risk of accidents.[70]

Snoring, which is one of the signals present in OSAS, has been associated with increased risk for accidents and morbidity. A study conducted in Hungary found that snoring is common in the adult population. Through interviews, the study showed that especially loud snoring with breathing pauses was strongly associated with health impairment, higher comorbidity, daytime sleepiness, and a higher frequency of accidents.[71]

A retrospective evaluation of snoring workers due to suggestive symptoms of OSAS found a significantly higher frequency of occupational accidents among these professionals when compared to the general population of snorers. In this study, all subjects underwent overnight polysomnography in a sleep laboratory and, interestingly, the risk of accidents was high among heavy snorers without apnea and patients with OSAS.[8]

A prospective study found that men who reported both snoring and excessive daytime sleepiness were with an increased risk of labor accidents during the 10 years of follow-up.[72] The high risk of traffic accidents among drowsy drivers was mainly determined by the respiratory effort-related arousals (RERA) than by the presence of apneas and hypopneas.[73] The RERAs are secondary to upper airway obstructions during sleep and can occur in the absence of apneas and hypopneas, causing excessive daytime sleepiness.

Studies using the esophageal pressure measure were performed in habitually sleepy drivers and drivers without this condition. Sleepy drivers with apnea had higher accident rates in five years than drivers in the control group. Nevertheless, a high rate of RERA, but not sleep apnea, was still a risk factor among drivers habitually sleepy. These findings confirm the importance of identifying RERA in routine examinations in sleep laboratories.[73]

Just like it occurs with civilians, excessive sleepiness is a risk to the safety of military that operate dangerous vehicles, machinery, or carry firearms. Military with untreated OSA are also at risk for suffering from decreased mental alertness and decreased cognitive function due to drowsiness. Military with mild-to-moderate OSA and upper airway resistance syndrome (UARS) often have abnormal results in the Maintenance of Wakefulness Test and therefore have a pathological tendency to fall asleep. A study conducted in 2009 among military personnel identified that 32% of the sample had UARS and 68% OSA.[74]

Effectiveness and efficacy of CPAP and oral appliances

The physician must diagnose sleep apnea and evaluate the patient’s risk for injuries. The patient should be informed about the risks and an appropriate treatment should be instituted. In addition, the doctor should provide a follow-up plan to determine if the treatment has decreased the patient’s risk for accidents.[75]

Although many investigations have pointed out that treatment of primary snoring and OSAS with CPAP or OA contributes to the reduction of vehicle and labor accidents,[12,33,34,36,76] this review did not find any studies evaluating the effectiveness of OA regarding this outcome.

Like several other medical treatments, the efficacy of CPAP or OA depends on the degree of identification of OSAS and the degree of adherence to the treatment among the diagnosed individuals.[35] Treatment with CPAP reduces the risk of accidents because it is used by the patient.[77] Nonetheless, adherence to CPAP continues to be a major problem when treating OSAS, although more recent data suggest that adherence may have improved in recent years. However, a recent study found that only 5% of professional drivers diagnosed with OSAS showed adequate adherence to CPAP.[35,78]

It is important to include the patients in the treatment decision, offering more than one type of therapy for patients with OSA. Despite the residual apneas with the use of OA, or the highest rate of effectiveness of CPAP in reducing AHI, the similarities between the results of such treatments may be related to the hours of use per night. The OA which are considered to have partial efficacy, when used for prolonged hours may lead to similar outcomes when compared with CPAP.[79]

The ability to pre-select suitable candidates for either treatment is important. Although some predictors of success with OA have been evaluated, further studies are needed to better predict which patient will have a higher level of success with the OA therapy.[79] Less obese patients with mild sleep apnea and certain craniofacial characteristics such as mandibular retrognathia proved to be good candidates for the OA therapy.[80]

When analyzing the economic impact of OSAS, it was highlighted that there was a lack of clarity concerning the epidemiology of accidents in patients correctly treated with CPAP. Furthermore, it was suggested that future studies are needed to evaluate the improvement in the labor activities of OSAS patients before and after treatment, as well as studies evaluating the cost-effectiveness between surgical and clinical treatments.[10]

Most studies regarding the adherence to OA use subjective measures to evaluate the therapy compliance.[81] Nevertheless, a study conducted in 2012 objectively evaluated the use of OA among patients undergoing therapy for OSA by means of a heat-sensitive microsensor, which was attached to the OA. The overall mean rate of OA use was 6.7 ± 1.3 h per day with a regular users’ rate of 82%. Despite not having a statistically significant difference between the self-report and the use of microsensor, the safety and feasibility of using this device to objectively measure the OA’s compliance was highlighted.[82]

Although, according to a systematic review, many studies have demonstrated the effectiveness of OA in reducing daytime sleepiness and improve the neurocognitive function,[19] the Federal Motor Carrier Safety Administration does not recommend the use of the OA in the treatment of OSAS among professional drivers, once there is no scientific evidence associating the reduction of accidents by using these devices and it is difficult to assess the patients’ treatment adherence.[83] Furthermore, an updated version of the Thoracic Society Clinical Practice Guideline recommended the use of CPAP to reduce accidents, but again the OA were not listed due to lack of scientific evidence about the effects of this therapy on the risk of accidents.[84]

The OSAS treatment options may become limited by the conditions of the work environment. The diagnosis of sleep-disordered breathing may affect the deployable strength of the military personnel due to the difficulty they might face concerning the use of CPAP.[74] Military deployed in desert environment are at a risk of inhaling airborne particulate matter that can harm their health. In this condition, the CPAP therapy can facilitate the inhalation of these particles. Therefore, alternatives to solve this problem such as using foam filters have been tested.[85]

Economic impact of OSAS

Obstructive sleep apnea affects the daily lives of millions of people around the world and presents a growing economic impact. The evidence linking OSAS with various public health problems such as obesity, diabetes, depression, cardiovascular disease, and accidents has increased.[10]

It is estimated that in the United States, the total costs attributable to sleep apnea-related accidents is quite high. In 2000, 1400 people died due to vehicular collisions and in 2004 these accidents had a cost of $ 15.9 billion. With regard to the management of accidents, it is estimated that the treatment with CPAP for all drivers who suffer from OSAS would be of $ 3.18 billion. Even taking into account a treatment efficiency of only 70%, there would be a reduction of $ 11.1 billion in collision costs and 980 lives would be saved per year.[13] The literature suggests that treating 500 patients for three years would result in savings more than $ 1,000. 000.[68]

A more recent analysis of OSAs’ treatment showed significantly lower costs of the treatment plan. In addition, it was also observed fewer disability claims; cost reduction for disability and fewer lost days of work.[86] A prospective study compared the effects of OSAS between men and women during 1994-2005. An increased risk of absenteeism in subjects with sleep apnea was observed. In women, the major risk was present five years before diagnosis, whereas in men the major risk was observed one year before the diagnosis of OSAS.[87]

Education campaigns encouraging members of health plans to seek specific treatment for sleep-disordered breathing resulted in substantial savings. Two years after the education campaign started, it was computed savings of U.S. $ 4,900.00.[88]

Dentists can play an important role in accident prevention through the detection of risk factors by screening their patients for OSAS, evaluating oral/jaws anatomical features, and screening for sleep disorders during the anamnesis.[14]

Use of health services and resources

Untreated obstructive sleep apnea predisposes patients to various morbidities and consequently increases the use of health services.[10,12,89,90,91] The risk assessment of OSAS among workers can help to reduce the national health care burden.[51] Evidence suggests that patients with untreated sleep apnea require a greater amount of health resources. Moreover, adherence to treatment in patients with OSAS results in a significant reduction in hospitalizations and medical applications.[92,93]

In 2013 a study comparing the health effects after one month of CPAP and OA therapy identified that despite the CPAP therapy was more effective in reducing the AHI, the therapy with OA had greater adherence, hence both therapies showed similar results.[94]

Cost-effectiveness of OSAS treatment

Concerning CPAP therapy, studies in several countries have evaluated its cost-effectiveness[12,95,96] Some patients have to try more than one treatment option before control of OSAS is reached. Treatment should be individualized and supported by scientific evidence, and the evaluation of cost-effectiveness is also required. Information about the therapy cost is important for the governments, transport, industry, and insurance agencies to plan actions to decrease the economic impact of untreated OSAS.[97]

Data on types of treatment for snoring and OSAS suggested that therapy with OA had lower costs when compared with other treatment modalities.[15] Nonetheless, it has not been evaluated yet the use of OA associated with reduced risk of vehicle and labor accidents. Further studies should evaluate from a social perspective the loss of work productivity, increased absenteeism, insurance, and costs and assess the use of OA in preventing occupational accidents.[10]

The cost-effectiveness of CPAP was compared with the OA therapy and lifestyle advice using a method of quality-adjusted life year (QALY) in a life perspective. On average, CPAP was associated with higher costs than other therapies. However, in another analysis CPAP was more profitable than OA. Therefore, regarding adults who suffer from moderate or severe symptomatic OSA it was concluded that CPAP has better cost-effectiveness when compared with OA and lifestyle advice.[98]

The OA are now widely prescribed for the treatment of OSAS, either as a primary or as an alternative measure to those patients unwilling or unable to tolerate CPAP therapy. Although CPAP has been shown to be more effective than OA[19] and highly cost-effective,[36] there are increasing evidences that OA improve drowsiness, blood pressure, and indices of sleep-disordered breathing.[79] Moreover, many patients who respond to both treatments generally prefer to use OA.[16]

Despite the limited evidence on the cost-effectiveness of OA, through this literature review it can be observed that OA are economically less attractive than CPAP, but remain as a cost-effective treatment for patients who do not want or do not adhere to treatment with CPAP.[99]

CONCLUSION

This review highlights the fact that OSA is a prevalent disorder among works, leads to increased risk of occupational accidents, greater use of health services, and has a significant impact on the economy.

The CPAP therapy reduces the risk of occupational accidents. Furthermore, it has been shown to be cost-effective, improve the work performance, and reduce health burdens. Regarding OA, despite showing an improvement in work performance, there is no scientific evidence of occupational accidents reduction. Moreover, there is limited evidence of its cost-effectiveness and its effect on reducing the use of health services.

Due to the lack of evidence regarding the use of OA for occupational accidents, future research should focus on determining the cost-effectiveness, influence, and efficacy of these devices in preventing occupational accidents among workers who suffer from OSA.

Footnotes

Source of Support: Nil

Conflict of Interest: None declared.

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70. Akkoyunlu ME, Altin R, Kart L, Atalay F, Ornek T, Bayram M, et al. Investigation of obstructive sleep apnoea syndrome prevalence among long-distance drivers from Zonguldak, Turkey. Multidiscip Respir Med.2013;8:10. [PMC free article] [PubMed]
71. Torzsa P, Keszei A, Kalabay L, Vamos EP, Zoller R, Mucsi I, et al. Socio-demographic characteristics, health behaviour, co-morbidity and accidents in snorers: A population survey. Sleep Breath. 2011;15:809–18.[PubMed]
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73. Masa Jimenez JF, Rubio GM, Findley LJ, Riesco Miranda JA, Sojo GA, Disdier VC. Sleepy drivers have a high frequency of traffic accidents related to respiratory effort-related arousals. Arch Bronconeumol.2003;39:153–8. [PubMed]
74. Powers CR, Frey WC. Maintenance of wakefulness test in military personnel with upper airway resistance syndrome and mild to moderate obstructive sleep apnea. Sleep Breath. 2009;13:253–8. [PubMed]
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76. Krieger J, Meslier N, Lebrun T, Levy P, Phillip-Joet F, Sailly JC, et al. Accidents in obstructive sleep apnea patients treated with nasal continuous positive airway pressure: A prospective study. The Working Group ANTADIR, Paris and CRESGE, Lille, France. Association Nationale de Traitement a Domicile des Insuffisants Respiratoires. Chest. 1997;112:1561–6. [PubMed]
77. Teran SJ, Moreno G, Rodenstein DO. Sleep medicine and transport workers. Medico-social aspects with special reference to sleep apnoea syndrome. Arch Bronconeumol. 2010;46:143–7. [PubMed]
78. Parks P, Durand G, Tsismenakis AJ, Vela-Bueno A, Kales S. Screening for obstructive sleep apnea during commercial driver medical examinations. J Occup Environ Med. 2009;51:275–82. [PubMed]
79. Pliska BT, Almeida F. Effectiveness and outcome of oral appliance therapy. Dent Clin North Am.2012;56:433–44. [PubMed]
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81. Ferguson KA, Cartwright R, Rogers R, Schmidt-Nowara W. Oral appliances for snoring and obstructive sleep apnea: A review. Sleep. 2006;29:244–62. [PubMed]
82. Vanderveken OM, Braem MJ, Dieltjens M, De Backer WA, Van de Heyning PH. Objective measurement of the therapeutic effectiveness of continuous positive airway pressure versus oral appliance therapy for the treatment of obstructive sleep apnea. Am J Respir Crit Care Med. 2013;188:1162. [PubMed]
83. Hiestand D, Phillips B. Obstructive sleep apnea syndrome: Assessing and managing risk in the motor vehicle operator. Curr Opin Pulm Med. 2011;17:412–8. [PubMed]
84. Strohl KP, Brown DB, Collop N, George C, Grunstein R, Han F, et al. An official American Thoracic Society Clinical Practice Guideline: Sleep apnea, sleepiness, and driving risk in noncommercial drivers. An update of a 1994 Statement. Am J Respir Crit Care Med. 2013;187:1259–66. [PubMed]
85. Kristo D, Corcoran T, O’Connell N, Thomas K, Strollo P. The potential for delivery of particulate matter through positive airway pressure devices (CPAP/BPAP) Sleep Breath. 2012;16:193–8. [PubMed]
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93. Albarrak M, Banno K, Sabbagh AA, Delaive K, Walld R, Manfreda J, et al. Utilization of healthcare resources in obstructive sleep apnea syndrome: A 5-year follow-up study in men using CPAP. Sleep.2005;28:1306–11. [PubMed]
94. Phillips CL, Grunstein RR, Darendeliler MA, Mihailidou AS, Srinivasan VK, Yee BJ, et al. Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: A randomized controlled trial. Am J Respir Crit Care Med. 2013;187:879–87. [PubMed]
95. Pelletier-Fleury N, Meslier N, Gagnadoux F, Person C, Rakotonanahary D, Ouksel H, et al. Economic arguments for the immediate management of moderate-to-severe obstructive sleep apnoea syndrome. Eur Respir J. 2004;23:53–60. [PubMed]
96. Tan MC, Ayas NT, Mulgrew A, Cortes L, FitzGerald JM, Fleetham JA, et al. Cost-effectiveness of continuous positive airway pressure therapy in patients with obstructive sleep apnea-hypopnea in British Columbia. Can Respir J. 2008;15:159–65. [PMC free article] [PubMed]
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Articles from Indian Journal of Occupational and Environmental Medicine are provided here courtesy ofMedknow Publications
Alan Hickey

Alan Hickey

Publisher of Sleep Diagnosis and Therapy Journal the Official publication of the American Sleep and Breathing Academy, the Journal is a clinical and technical publication for dental and medical professionals.

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CPAP

Overlooked No More – Hybernite Rainout Control System

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ScreenShot146 Overlooked No More Hybernite Rainout Control SystemCould a Different Tube Actually Make the Difference in the Battle for Compliance?

The CPAP compliance equation usually hinges on a common belief: find the right mask and comfort will follow. Comfort equals compliance, and compliance equals reimbursement. The strategy makes sense, but variables can complicate matters.

For example, what if the “best” mask is still too uncomfortable? Johan Verbraecken, MD, a pulmonologist and medical coordinator at the Belgium-based Sleep Disorders Centre, has seen this scenario on many occasions. One recent patient wanted to stop CPAP treatment after many failed attempts. “I asked him to try one more thing before he stopped,” says Verbraecken. “The only thing we changed was adding a heated tube. The patient was comfortable and happy with this intervention. We focus so much on changing masks, but tubes are often overlooked.”

Using the heated tube from the beginning, along with the heated humidifier, can also benefit sleep labs economically since fewer patients are likely to stop due to condensation. “Patients get moisture on their face at night, and it is not comfortable,” says Verbraecken. “The condensation can also make noise in the tube, similar to the sound of boiling water. This noise can often lead to stopping CPAP use, but the right tube can completely prevent it.”

New Respect

A few companies have been paying close attention to tubes, and clinicians are now looking to the technology in an effort to find any edge in the race to boost compliance. The transfer of air from machine to patient is no longer overlooked. In fact, the field is literally getting hotter with heated tubes reducing the pesky problem of condensation.

A company called Plastiflex Healthcare, a division of Plastiflex Group NV, decided to use its considerable experience manufacturing industrial flexible hoses and apply it to CPAP. Plastiflex contacted Verbraecken’s Centre about 2 years ago as it reached out to the European market.

Plastiflex offered the Hybernite® Rainout Control (ROC) System, which includes the proprietary Hybernite® Heated Breathing Tube (HBT) and Hybernite® Power Supply Unit (PSU). The HBT connects to the PSU via a plug-and-play connector, with copper wires embedded in the tubing wall.

The wires generate heat that maintains air temperature inside the tube, ultimately warding off problematic condensation. Verbraecken notes that the wires are positioned for uniform heating along the tube’s entire length, a system that avoids water droplets on the wall of the tube—and the resulting accumulation of moisture. The combination of the heated tube and the humidifier works to control condensation.

Ludo van der Poel, area manager at Netherlands-based Vivisol, a home care company that supplies Hybernite systems to patients, agrees that the seemingly minor detail of the tube can make a major difference. “The old saying about the weakest link in the chain also applies here,” says van der Poel. “If you have a superior mask and a superior CPAP device, but a bad tube, you will not get the best results.”

Universality is Key

With critical CE approval in hand, Verbraecken says the Hybernite’s appeal stems from its ability to be used with each kind of humidifier. Other heated tubes on the market can only be used on one machine. “This tube is universal,” says Verbraecken. “That is a major advantage.”

Some manufacturers choose to make tubes that are only compatible with their own machines—a mistake in Verbraecken’s eyes. “I think it’s the wrong decision,” he says. “You are obliged to use their machine, and it’s protection for them. The market is so huge that it does not make sense anymore.”

Titrations with Humidification?

At the moment, titration with humidification and heated tubing is not common. However, in cases involving chronic sinusitis and nasal obstruction, Verbraecken contends that the ScreenShot145 Overlooked No More Hybernite Rainout Control SystemHybernite could be an advantage. “You could eliminate specific side effects that could be disturbing and that could make a difference,” he says. “For many people, condensation feels as if the water is running from their nose and on to their face. It is like being in a swimming pool, and for many it is unacceptable.”

Better tubes have the potential to enhance CPAP and ultimately improve patient care, although studies must be done to back up this notion. “There is room to use these tubes in a routine setting and not just as an escape tool,” says Verbraecken. “We need large trials to look at the effects of routine application, which has the potential to enhance the objective of compliance.”

Nuts and Bolts

Close proximity to Plastiflex’s European headquarters fostered a relationship with officials at Vivisol who were able to give advice during Hybernite’s development. “We discovered this product before it was launched,” reveals van der Poel. “We were involved in the early stages, giving input from the field to the developers at Plastiflex to further refine the product prior to its launch.”

Years prior to contacting Verbraecken, Plastiflex officials also underwent an exhaustive fact-finding period that took them to numerous trade shows and visits with industry professionals. Designers narrowed down CPAP tubing complaints to condensation and comfort, and refining technology to deal with these two problems has remained the top priority.

After taking into account all this information, engineers developed a Hybernite® ROC that essentially consists of two main parts; one is a heated breathing tube and the other is a power supply. With standard conical connectors, company engineers claim that the Hybernite® ROC can fit the role of a universal solution that can be fully integrated into any humidifier—including all types of masks that use standard tubes. “We like the flexibility of the tubing and the high quality plastic,” adds van der Poel. “A tube that is not flexible or long enough could prevent patients from moving in an easy way. Poor quality can also lead to breakage.”

The system itself does not take power or require power to be taken from the humidifier. It takes the energy straight out of the socket in the wall via the Power Supply Unit (PSU). The system works with all humidifiers that currently use standard tubing—which is 99% of the market.

————————————————————–

Johan Verbraecken, MD, is a pulmonologist and medical coordinator at the Multidisciplinary Sleep Disorders Centre, Antwerp University Hospital and University of Antwerp. He also serves as vice president of the Belgian Association for Sleep Research and Sleep Medicine.

 

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CPAP, Home Sleep Testing

Aerophagia and Gastroesophageal Reflux Disease in Patients using Continuous Positive Airway Pressure: A Preliminary Observation

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Nathaniel F. Watson, M.D.1 and Sue K. Mystkowski, M.D.2
1Department of Neurology, University of Washington, Seattle, WA
2Department of Medicine, Division of Pulmonary and Critical Care, University of Washington, Seattle, WA
Address correspondence to: Nathaniel F. Watson, University of Washington Sleep Disorders Center at Harborview, Box 359803, 325 Ninth Avenue, Seattle, WA 98104-2499Phone: (206) 744-4337Fax: (206) 744-5657,; Email: nwatson@u.washington.edu
Received February 2008; Accepted May 2008.
Abstract
Study Objectives:
Aerophagia is a complication of continuous positive airway pressure (CPAP) therapy for sleep disordered breathing (SDB), whereupon air is forced into the stomach and bowel. Associated discomfort can result in CPAP discontinuation. We hypothesize that aerophagia is associated with gastroesophageal reflux disease (GERD) via mechanisms involving GERD related lower esophageal sphincter (LES) compromise.
Methods:
Twenty-two subjects with aerophagia and 22 controls, matched for age, gender, and body mass index, who were being treated with CPAP for SDB were compared in regard to clinical aspects of GERD, GERD associated habits, SDB severity as measured by , and mean CPAP pressure.
Results:
More subjects with aerophagia had symptoms of GERD (77.3% vs. 36.4%; p < 0.01) and were on GERD related medications (45.5% vs. 18.2%, p < 0.05) than controls. Regarding polysomnography, mean oxygen saturation percentages were lower in the aerophagia group than controls (95.0% vs. 96.5%, p < 0.05). No other differences were observed, including mean CPAP pressures. No one in the aerophagia group (vs. 27.3% of the control group) was a current tobacco user (p < 0.01). There was no difference in caffeine or alcohol use between the 2 groups.
Conclusions:
These results imply aerophagia is associated with GERD symptoms and GERD related medication use. This finding suggests a relationship between GERD related LES pathophysiology and the development of aerophagia in patients with SDB treated with CPAP.
Citation:
J Clin Sleep Med 2008;4(5):434–438.
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CPAP

Understanding Pressure Transducers and Pressure Flow Signals

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By Rick Swanson, RPSGT, CRTT

A sensor or electrode acts as a transducer by taking one form of energy and converting it to another form of energy (i.e., a signal that is put into sleep data recording systems).  A snore sensor takes the vibrations of snoring and produces an electrical signal of that vibration.  Similarly, a pressure transducer measures the pressures of breathing and puts out an electrical signal showing the flow of breathing.

How does a pressure transducer do that?

Image1 Understanding Pressure Transducers and Pressure Flow SignalsImage2 Understanding Pressure Transducers and Pressure Flow Signals

Courtesy Maxim Integrated Products

The figure above on the left is of a Wheatstone bridge circuit. The figure above on the right depicts a pressure transducer chamber. The Wheatstone bridge circuit is etched directly onto the pressure transducer chamber, and when it is in use a voltage is applied to the circuit.  The pressure coming into the pressure transducer chamber deforms, or bulges, the side of the chamber.

The resisters shown in the figure above on the left (R1, R2, R3, and R4) are variable resisters.  Their values change as the transducer wall deforms when pressure is introduced to the pressure chamber.  The signal output value is changed by the changes in the resister values and a pressure signal is produced.

Pressure transducers used in sleep can be broken down by power source and by transducer type. In sleep testing today there are two types of power sources for pressure transducers:  1) replaceable batteries; 2) a piezo power source.  There are also two types of pressure transducers:  1) a differential transducer (two ports); 2) a gauge transducer (one port). The differential transducer is usually battery-powered and the single port is piezo-powered.  The differential transducer measures the pressure difference between the two input ports. The gauge measures one pressure against ambient pressure.


Differential Gauge
Power source Replaceable batteries Piezo crystals
Inputs Two One
Advantages

Measure patient flow on CPAP
Compatible with more systems

 Small size
No batteries to replace
Disadvantages Batteries to be replaced Compatibility issues

Often the type of recording system can dictate which type of pressure transducer can be used.
System compatibility should be determined with your system provider or the pressure transducer manufacturer.

Filter settings

To record the signal from the pressure transducer accurately, the flow channel must have a long time constant. This is a very low setting on the low frequency filter (high pass filter).  This will allow the signal to remain above baseline and show the possible narrowing of upper airways. The result is a prolonged or stretched waveform that appears as flattening when compared to previous, “untroubled” breathing waveforms.

To see all the details in the signal, use the following settings:

  • Low Frequency Filter (High Pass Filter): 0.05 – 0.01 Hz
  • Time Constant: 3 – 5 seconds
  • High Frequency Filter (Low Pass Filter): 15 – 70 Hz
  • Sampling Rate: 25 Hz or higher

Assuming a normal/average respiratory rate of 12 breaths per minute, 12/60seconds = 0.2 Hz.
The high frequency filter can be set very low without affecting the pressure waveform.

The Technical Specifications of AASM Guidelines (pg 19) has a Low Frequency Filter of 0.1 Hz for all respiration channels.  Using that filter setting will make the pressure signal look like a thermal signal.  Using the correct low frequency filter is not a violation of the Guidelines.

The Low Frequency Filter (LFF) is also known as the Time Constant (TC).
0.16=1/2p
TC=0.16/Frequency (F)
F=0.16/TC

There is an inverse relationship between the LFF and TC. The lower the LFF, the longer the TC.
The longer the TC, the more time the signal has to display flattening. A LFF setting of 0.05 Hz is approximately three seconds. A breathing rate of twelve breaths per minute allows five seconds for each breath cycle. The TC is the time it takes for the signal/waveform to return to baseline. If the TC is set too short the signal will not be able to show flattening. Conversely, if the LFF is set too high the signal will not be able to show flattening above baseline.

ScreenShot115 Understanding Pressure Transducers and Pressure Flow Signals

Cannulas

The AASM Guidelines call for a nasal pressure signal. The thermal device measures both nasal and oral airflow.  A nasal cannula is less obtrusive than a nasal/oral cannula. Nasal/oral cannulas may be subject to a loss of signal due to pressure going through the oral prong.

When placing the nasal cannula on a patient, the nasal prongs may be trimmed, as needed, for patient comfort. The prongs should be placed at the opening of the nostrils to measure the pressure of flow.  The cannula should be securely positioned to a thermal device placed against the upper lip.   This should help minimize the tendency for the cannula to roll into the nostril and “bottom out” against the inside of the nose.

A cannula is a column of air. The column has the capacity to change pressure and transmit the pressure to the pressure transducer. There is no flow through the cannula. It changes pressure and this pressure change is transmitted to the pressure chamber.

Image3 Understanding Pressure Transducers and Pressure Flow Signals

On inhalation the nasal prongs experience a negative pressure due to the Venturi effect of the air flowing around the nasal prongs into the nostril. On exhalation they act as pitot tubes, accepting a positive pressure from the air pressing in on the nasal prong openings.  These pressure changes are transmitted to the pressure chamber.

Square root transformation

The Guidelines of the AASM state under the Respiratory Rules for adults: “Nasal air pressure transducer with or without square root transformation of the signal.”  For children, the Guidelines state: “Nasal air pressure transducer without square root transformation of the signal.”

What is this square root transformation of the signal?  It is a method by which the electrical output from the pressure transducer is put through a circuit that would electronically apply a square root mathematical expression to the signal.  The objective of this is to make the signal more linear.  The signal is generated by the deformation of the pressure chamber and is not always linear.

If your sleep facility tests both children and adults, use pressure transducers without the square root transformation of the signal.  There are no pressure transducers currently available with the square wave transformation.

There have been a number of articles published showing that this transformation does not appreciably change results. All measures of sleep-disordered breathing remain the same whether the square root transform is used or not. One of the papers validating this is:

“Validation of Nasal Pressure for the Identification of Apneas/Hypopneas during Sleep” Steven J. Heitman, Raj S. Atkar, Eric A. Hajduk, Richard A. Wanner and W. Ward Flemons Departments of Medicine and Sociology, Foothills Hospital and University of Calgary, Calgary, Alberta, Canada

This paper is also available online at:  http://ajrccm.atsjournals.org/cgi/content/full/166/3/386#TBL1

Anatomy of the pressure waveform

Nasal pressure waveforms contain a lot of information about a patient’s upper airway status and can look very different from thermal signals.  A thermal signal is nice and linear, as the elements heat and cool. The pressure waveform, however, can be jagged and spiky. This is because it is measuring pressure which can have sudden changes, especially as someone breathes.

z1 Understanding Pressure Transducers and Pressure Flow Signals

The figure above shows a typical pressure airflow waveform labeled with the actions of breathing that it depicts.

z2 Understanding Pressure Transducers and Pressure Flow Signals

The diagram above shows a peculiarity that often appears and is called the end expiratory pause.  There are three parts to breathing: 1) inhale; 2) exhale; 3) pause.  For some people this pause will show up in the pressure flow waveform.

z3 Understanding Pressure Transducers and Pressure Flow Signals

This is a depiction of the flattening seen in the pressure flow waveform due to snoring or upper airway resistance syndrome (UARS).  The narrowing of the upper airways during a snore or UARS prolongs the inhalation. This is because the same volume that was previously moved in and out of the lungs now must go through a smaller opening, reducing the pressure and taking longer to move the air into the lungs.

z4 Understanding Pressure Transducers and Pressure Flow Signals

The above figure shows more detail of the anatomy in the pressure waveform during a snoring event.

z5 Understanding Pressure Transducers and Pressure Flow Signals

The above figure shows why the low frequency filter settings are important. The bottom waveform clearly shows the flattening of UARS using a DC input from the pressure transducer. The middle waveform also displays this flattening in an AC channel with a long Time Constant (low filter set at 0.05 or 0.01 Hz). At the top a decrease in amplitude is visible. It is very difficult, however, to see flattening in the waveform because the short Time Constant (higher low filter setting ~0.1Hz) does not allow the signal to remain above baseline long enough to properly display flattening.

All of the included figures are representations of possible waveforms seen with pressure transducers. The figures are suggestive of settings to expect while using pressure flow signals. If a patient does not display a signal exactly like these illustrated, it does not mean that the patient isn’t having these events.

Using pressure airflow in conjunction with thermal airflow affords the technologist the ability to see apneas and hypopneas with the specific equipment developed for those events.  The signals from the two technologies look different because they are two different technologies measuring the same parameter. Neither technology is more right than the other.  Pressure is more sensitive to hypopneic events and thermal is more sensitive to apneic events. Together they provide a more complete picture of the patient’s airflow.

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California Dreaming

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bed California DreamingOfficials at the Orange County, Calif-based Judy & Richard Voltmer Sleep Center make sleep health a priority throughout the many specialties at Hoag Memorial Hospital.

Even in the population-dense region of Southern California, sleep labs used to be rare. When compared to 2011, sleep apnea awareness in the 1980s significantly trailed other conditions.

Officials at Hoag Memorial Hospital Presbyterian in Orange County, Calif, recognized early on that there was a need for a specialized center to evaluate and treat sleep disorders. The Judy & Richard Voltmer Sleep Center, backed by the resources at Hoag, filled this void back in 1987 in Newport Beach, Calif. More recently, the center moved to gleaming new quarters in an effort to modernize and accommodate more patients.

With considerable resources, expertise, and referrals flowing from Hoag, the state-of-the-art 8-bed facility never lacks for patients. Paul Selecky, MD, FACP, FCCP, FAASM, long-time medical director of the Voltmer Sleep Center, has tirelessly spread the message of sleep health among his colleagues. The result is that clinicians from diverse specialties appreciate the value of healthy sleep, and they don’t hesitate to ask for help when they need it.

Under the umbrella of Hoag , the Voltmer Sleep Center is seamlessly integrated within the continuum of care. Sleep is not an afterthought. Neurologists, ENTs, pulmonologists, endocrinologists, and all readily send patients to the center.

Colleagues on Board

The evidence for the sleep/health connection seems to build each year, with ever-more co-morbidities related to poor sleep. The more apt question these days is what is not affected by sleep.

When the American Society of Anesthesiology (ASA) came out with its 2006 guidelines on peri-operative management of patients with known or suspected sleep apnea, clinicians at Voltmer Sleep Center were ready. “Our anesthesiologists asked if we could help them develop a program to screen patients who were coming in for elective surgery,” says Selecky. “That protocol has now grown, and nearly every admission coming into Hoag is evaluated for the risk factors of sleep apnea.”

Hoag has taken a proactive approach, and patients who come in for other ailments benefit from the extra attention. “About 70% of stroke patients have sleep apnea,” says Selecky. “It’s a chicken-egg type of thing, but at least they get sent here to lower that risk. Others who come in for total knee, hip, chest pain—we ask them about sleep and the patient is educated about serious breathing problems.”

Not surprisingly, about 90% of all referrals to Voltmer Sleep Center come from Hoag, but outside referrals are growing. If a patient is referred by a Hoag neurologist for sleep problems related to that neurologic problem, a neurologist working on staff at Voltmer Sleep Center is the one to see that patient.

If COPD was the primary problem, a would visit with the patient. “This is not just an independent sleep center,” explains Trish Stiger, BBA, RPSGT, CRT, manager of the Voltmer Sleep Center. “It is part of Hoag, and they refer from the Diabetes Center, the Cardiovascular Institute, and more. Even obstetricians are reminded that a snoring pregnant woman should not be ignored as if she merely has nasal congestion, as this can lead to complications of pregnancy.”

In line with the large body of evidence linking sleep apnea and congestive heart failure, Voltmer Sleep Center clinicians provide information and education to all Hoag . “A lot of them have gotten the message,” says Selecky. “They ask every congestive heart patient, ‘Do you snore?’ If the patient snores, and has other features of sleep apnea,  he comes to us.” will also send patients whom they are treating for resistant hypertension, as is recommended by the American College of Cardiology and American Heart Association because of the link with untreated obstructive sleep apnea.

Much the same can be said for diabetes management. Endocrinologists who prescribe several different medications for diabetes have referred their patients to the Center, again because of the link between diabetes management and sleep apnea  . “The first thing that should be done is to rule out sleep apnea,” says Selecky.

Education and Follow-up

Every physician takes patients to the lab bedrooms to explain the diagnostic tests and procedures, and these in-person consultations provide vital information. Despite all the media attention on sleep, Selecky admits that some convincing is often part of the job. “Sometimes there is too much negative information out there,” laments Selecky. “People come in and say, ‘I don’t want that breathing machine. I know somebody that hated it.’ It gets a bad rap, so we must provide a lot of education.”

When it comes time to dispensing the actual machine, Selecky and Stiger work closely with trusted (DME) providers who are known for their good service. “If they don’t provide good service, we don’t refer to them—it’s that simple,” says Selecky. “That means excellent follow-up, because if patients don’t have a positive experience in the first few weeks of CPAP use, they are more likely  to abandon it. Nationally, the average for CPAP users is that 50% drop it by the end of the first year. We have several of the DME RTs spend time in the Center so patients can try a dozen different masks. It’s like buying a pair of shoes. If it doesn’t fit well, you are not going to use it.”

In addition to the familiar sleep apnea/CPAP combination, officials at Voltmer are keen to address all sleep disorders and treatments. “Insomnia is not a huge percentage of our patient population at this point, but it’s significant enough and our physicians treat it,” says Stiger. “Patients may need extensive cognitive behavioral therapy, sometimes with the aid of  psychologists.

In addition to CPAP for apnea, we embrace dental sleep medicine as a valid option.  “Oral corrective devices have been used throughout our history with the help of local dentists who started treating some of our milder patients, or those who could not tolerate CPAP,” adds Selecky.

The Future

Unlike the 1980s, Selecky says it seems as though these days there is a on every corner. Favorable demographic trends suggest that won’t change, despite the furor caused last year when Medicare approved studies—much to the chagrin of lab owners. “People said that might be the end of all ,” says Selecky. “But as time has gone on, that has not occurred at all. Part of it is that reimbursement for studies is low. However, it has made every lab consider whether it should be involved in studies. The answer is yes for certain populations.”

In 2011, Selecky believes the keys to success looks a lot like the keys of the past. Education, clinical excellence, follow-up, and compliance must be the driving forces. As understanding of sleep medicine grows and physicians know more about it, they will inevitably order more sleep studies.

Those who have worked to be a full service center will remain in the black as they gain the trust of physicians and patients alike. “There is a difference between establishing yourself as a sleep center vs a sleep lab,” adds Stiger. “A center deals with everything. You educate, go out and teach the community, and work with all the other specialties to care for patients—which should always be the number one goal.”

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Tradition of Excellence
Hoag Memorial Hospital Presbyterian is accredited by the Joint Commission on Accreditations of Healthcare Organizations (JCAHO), and home to Centers of Excellence in cancer, heart, orthopedics and women’s health services. Orange County residents named Hoag the “Hospital of Choice” in a National Research Corporation poll, as well as the county’s top hospital in a a local newspaper survey.

The Voltmer Sleep Center is an accredited member of the , and features a Web site (http://www.hoag.org/services/neurosciences-institute/voltmer-sleep-center) where potential patients can view online sleep assessments, photos of the sleep center, and information about the physicians. “Many people simply don’t realize that an adequate night’s sleep is needed to maintain good health and stay fully alert throughout the day,” says Selecky. “We are excited about the opportunity to use the Internet to educate the public and to let them know there is help nearby.”

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Demystifying the Accreditation Process for Sleep Labs

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The president of The Compliance Team seeks to demystify the accreditation process for sleep labs.

After meticulously building a solid reputation in the world of DME accreditation, Sandra Canally is determined to bring her simplified approach to sleep labs. As president of The Compliance Team Inc, based in Spring House, Pa, Canally has long worked on the premise that excellence in health care delivery is best achieved by dramatically simplifying quality standards.

In Fall 2006, The Compliance Team (TCT) got a chance to implement this philosophy in a big way when the Centers for and Services () formally granted the company deemed status to accredit providers of all types of DME, prosthetics, orthotics, and supplies (DMEPOS). Beyond the mandates that often accompany accreditation, Canally believes the entire process ultimately boosts patient care and improves business practices.

While TCT continues to actively accredit home care providers, these days company officials are also targeting that may be looking for an alternative to the (). “I created the sleep center program quite a few years ago,” says Canally, who launched the Exemplary Provider™ accreditation programs more than a decade ago. “I created it because DMEs were expanding and adding —and doing a lot of business with sleep labs.”

With “deemed” status for DME now long established, Canally can accredit sleep labs that wish to “self dispense” CPAP units. “We can package the and CPAP sales together and you are fully approved to bill Medicare,” says Canally. “The major national sleep organization [AASM] is not able to do that because they are not CMS approved for DMEPOS.”

Beyond the Medicare scenario, TCT can offer accreditation for sleep labs that encompasses all aspects of the lab’s operations. “A big misconception is that the major national sleep organization is the only player, and the same thing can be said of hospitals when it comes to the Joint Commission,” says Canally. “We provide an alternative that is not all about the minutia and jumping through hoops. We believe in simplification. We have led the movement within DME and other markets, and we are introducing these accreditation concepts for sleep centers. Simplification leads to clarity, and clarity allows the provider to focus on what matters most—safety, honesty, and caring.”

These three principles are all part of what TCT officials call the “Exemplary Provider” brand. “The word ‘exemplary’ means you are setting yourself apart from other providers that are just doing the minimum,” says Canally. “To accredit, you need to score 90% or better. So already we are setting the bar higher as our minimum standard.”

These days, TCT is opting to renew accreditation on a 3-year term, as opposed to the old 1-year process. During the 3-year span, providers still send in required items such as updated quality initiative plans, licensure documents, and proof of annual training.

In-person visits can be expected at least once during the 3 years, perhaps twice depending on the product lines. Second visits are focused only on patient care. “Since patients come in to a sleep lab in the evening, the sleep labs that we have accredited thus far have required night visits,” says Canally. “For one company that had three locations, we went in during the evening and stayed through the night and into the morning to see the whole process.”

With other sleep labs, TCT members have instead gone in extremely early in the morning. With this method, they could still see patients waking up and were able to ask questions about the night before, as well as take a peek at the sleep study. “We are not bound by Medicare to do unannounced visits on sleep labs,” explains Canally. “Unlike us, the AASM puts their complete focus on the medical director and the sleep study itself—all the technical aspects.

“My belief, and this is at the foundation of our program, is that the full evaluation should encompass operational excellence,” adds Canally. “Operational excellence leads to clinical excellence. You are not going to have the very best sleep study if you are not doing things right operationally—and that is the big difference between us and the AASM. We are looking at the whole picture of the organization, and they are looking at a small picture.”

If providers, including sleep labs, do not want to get accredited, or don’t need to do it for Medicare, there are other payors out there too. “A lot of the private pay organizations in managed care require accreditation to get on their network,” says Canally, who still maintains her active RN license. “A lot of the state Medicaid organizations are going toward accreditation. It’s just good business practice.”

Accreditation usually takes between 3 and 4 months, and most of the time it is a relatively pain-free process. Canally attributes the lack of pain to simplified standards that are written in plain language. “Providers are more compliant because there are no surprises,” says Canally. “We want their focus to be on improving operations and better serving patients.”

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Volume 6.1 : January 2011

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ScreenShot0621 Volume 6.1 : January 2011
Inside Look
  • East Coast Lab Preps for Potential – C. Albertario
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  • Ultra Light Type 3 Sleep Monitor – S. Weimer
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HTML PDF
Editorial
  • Man Vs. Machine – N. Norin
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A New Solution for CPAP Tubing – Hybernite

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The ®  (ROC) System

Flashy  units and masks dominate the sleep technology landscape, but the right tubes can mean the difference between compliance and failure. engineers and market experts examined the sleep technology market and determined that their expertise in industrial tubing systems could bolster the all-too-common weaknesses found in  systems

After an exhaustive fact-finding period, designers narrowed down  tubing complaints to condensation and comfort. According to Rik Langerock, marketing manager for Plastiflex Healthcare, condensation in the breathing circuits was a persistent problem, and a key area where his Belgium-based company could make a difference.

“We spoke to many different people in the supply and value chain and it was condensation in the respiratory tubes that we found to be significant,” says Langerock. “A second related need was about bringing more comfortable air to the patient.”

Comfort usually means warmer and/or more humid air, and this is where Plastiflex is able to use its considerable expertise. Other factors such as mask materials and proper fit play a role, but Langerock and his team were determined to only tackle what they knew best. “You must understand what matches with your core competency as a company,” says Langerock. “Our core competence is in the design and manufacturing of  solutions.”

Plastiflex engineers ultimately came up with the ®  (ROC) System, which includes the proprietary ®  (HBT) and ® Power Supply Unit (PSU). The HBT connects to the PSU via a plug and-play connector, with copper wires embedded in the tubing wall. These wires generate heat that maintains air temperature inside the tube, ultimately warding off problematic condensation. The wires are positioned for uniform heating along the tube’s entire length, a system that avoids water droplets on the wall of the tube and the resulting accumulation of moisture.

Read full article: Tubes the Unsung Heroes

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Don’t Neglect Snoring During CPAP Titration – SnoreTac Snore Sensing Adapter

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The Salter Labs BiNAPS and other select pressure transducers are utilized during sleep disorder studies to simultaneously measure respiratory airflow and snore pressure signals via a sleep diagnostic cannula. When titration to CPAP is initiated it previously required switching to a snore microphone/sensor. Now with the Salter Labs® SnoreTac™ Snore Sensing Adapter, all that is required is for a to utilize the SnoreTac™ Adapter with the existing sleep diagnostic cannula and place it securely on the patient’s neck.

The BiNAPS will provide a clean snore signal with less signal artifact than traditional sensors. This eliminates the need for a snore microphone/sensor. This technology is disposable for single patient use. It saves time and money, while eliminating the cleaning, damage and replacement issues associated with alternative snore sensors.

The Salter Labs SnoreTac™ was developed by engineers in the Salter Labs R&D department in response to requests from sleep labs for a way to improve snore signals and utilize their existing BiNAPS devices during CPAP titration to monitor snoring. The result is a small, lightweight disposable adapter that attaches to the Salter Labs® sleep cannula and utilizes existing piezo sensor technology in the BiNAPS® to deliver a clean, accurate signal to the PSG equipment or other data acquisition system.

Company officials believe the SnoreTac™ will benefit all sleep labs using Salter Labs® BiNAPS® and other combination airflow pressure/snore devices, as well as labs who are dissatisfied with their current snore microphone/sensors. Ultimately, the SnoreTac™ allows for improved detection of snore events with less  artifact, while providing a low cost disposable adapter that can be disposed of after each use.

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Don’t Overlook Tubes – Hybernite Rainout Control System

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The Hybernite® Rainout Control (ROC) System

Flashy CPAP units and masks dominate the sleep technology landscape, but the right tubes can mean the difference between compliance and failure. Plastiflex engineers and market experts examined the sleep technology market and determined that their expertise in industrial tubing systems could bolster the all-too-common weaknesses found in CPAP systems

After an exhaustive fact-finding period, designers narrowed down CPAP tubing complaints to condensation and comfort. According to Rik Langerock, marketing manager for Plastiflex Healthcare, condensation in the breathing circuits was a persistent problem, and a key area where his Belgium-based company could make a difference.

“We spoke to many different people in the supply and value chain and it was condensation in the respiratory tubes that we found to be significant,” says Langerock. “A second related need was about bringing more comfortable air to the patient.”

Comfort usually means warmer and/or more humid air, and this is where Plastiflex is able to use its considerable expertise. Other factors such as mask materials and proper fit play a role, but Langerock and his team were determined to only tackle what they knew best. “You must understand what matches with your core competency as a company,” says Langerock. “Our core competence is in the design and manufacturing of hose systems solutions.”

Plastiflex engineers ultimately came up with the Hybernite® Rainout Control (ROC) System, which includes the proprietary Hybernite® Heated Breathing Tube (HBT) and Hybernite® Power Supply Unit (PSU). The HBT connects to the PSU via a plug and-play connector, with copper wires embedded in the tubing wall. These wires generate heat that maintains air temperature inside the tube, ultimately warding off problematic condensation. The wires are positioned for uniform heating along the tube’s entire length, a system that avoids water droplets on the wall of the tube and the resulting accumulation of moisture.

Read full article: Tubes the Unsung Heroes

 

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