Category Archives: Home Sleep Testing

Better Business Beyond the Turf Wars

Sleep awareness has blossomed over the last decade, and it’s hard to find anyone who believes the market is anywhere near its peak. Consumers and members of the medical community increasingly agree that better sleep is a must for improved overall health.

With all that positivity, Jeremy Andra still wonders why the business climate surrounding sleep remains unsettled. “We know things are changing, and have to change even more with heath care the way it is right now,” says Andra, sleep products manager for Washington-Ambulatory_EEG-001based Cadwell Laboratories. “It’s not going to be back the way it was. Do we want to sit around and wait for insurance companies to figure it out? I don’t think so, because they usually get it wrong. In fact, many misunderstandings can happen.” As one example, Andra points out that the phenomenon of home sleep testing was never meant to hurt the sleep market, but instead to help it. That message may be getting through in much the same way that it did years ago in the cardiology market. “Cardiologists once complained that family practice physicians wanted to do their own EKG strips,” explains Andra, who has opened up more than 100 sleep clinics in a lengthy sleep-related career. “They were crying foul saying this will hurt us, and you don’t know enough about the heart like we do. Family practice came back and said, ‘You’re right, but we do know what a normal EKG looks like, and if it’s abnormal, we’ll send them to you.” Andra is keen to examine the progress of relevant specialties in an effort to develop and expand Cadwell’s sleep diagnostic products (which includes digital video software that allows users to display video movement as a channel in recording montages). Ultimately, Andra is intent on bringing disparate groups together to better all facets of the sleep industry.
Continue reading Better Business Beyond the Turf Wars

Jeremy Andra, RPSGT, RST

Jeremy Andra, RPSGT, RST

Mr. Andra is well known throughout the western United States for bringing sleep programs from initial startup to full operational capabilities by opening approximately 100 sleep facilities. Mr. Andra has been involved in sleep medicine since 1990 when he started one of the first sleep labs using computerized digital systems and one of the earliest portable EEG services in the market. Later, he was involved in large drug research studies as well as evaluating and field testing various medical devices needing FDA approvals including auto technologies with major PAP companies. Mr. Andra then added the dental sleep medicine as a part of his focus. He developed a dental tool named the “Andra Gauge” that is now sold internationally. The Andra Gauge has won Medical Innovation Awards and Dental Products Report had it in their “Top 10 Most Wanted Products”. As a regular on the sleep industry speaking circuit, Jeremy Andra is known for bringing both medical and dental professionals together to create successful business and patient models for Sleep Medicine. Mr. Andra now serves as Product Manager and Business Development Manager for Cadwell Laboratories.

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ResMed announces its AirView compliance management platform (previously EasyCare Online) is now securely connected to Fairview Health Services Epic EHR system, enabling up to date delivery of sleep apnea patient data for use by Fairview’s medical staff

 

Launched in June 2014, the integration of this data supports streamlined workflow, reduced cost, improved quality and responsiveness of therapy, and automated access to data for analytical and clinical outcome decision support.

 

Data generated by PAP devices, such as the ResMed S9 series and AirSense™ 10 series, enables medical professionals to remotely monitor patient therapy compliance to take appropriate action based on specific outcomes. With ResMed’s AirView connection to Fairview’s Epic EHR, clinicians now have access to patient PAP therapy data within their EHR system, eliminating the need to log in to multiple patient management systems to view patient outcomes.

 

Key features enabled with this solution include:

• boarding of sleep therapy patients from the EHR into the ResMed AirView patient management system;

• daily updating of PAP therapy effectiveness data from the patient’s home directly into the EHR via AirView;

• sleep health therapy management workflow and tracking tools embedded in the EHR, displaying key patient PAP metrics for various time intervals, customized to meet the needs of Fairview clinicians; and

• creation of a secure patient data warehouse to support advanced analytics such as the impact of sleep apnea on comorbid conditions.

 

“The healthcare system is under significant pressure to drive down the cost of care while still delivering exceptional patient outcomes,” said Raj Sodhi, Vice President, Healthcare Informatics at ResMed. “Sleep apnea represents one area where technology integration can play a key role in making that happen.”

 

Source: ResMed News

The post ResMed announces its AirView compliance management platform (previously EasyCare Online) is now securely connected to Fairview Health Services Epic EHR system, enabling up to date delivery of sleep apnea patient data for use by Fairview’s medical staff appeared first on Sleep Diagnosis and Therapy.

A systematic review of the efficacy of oral appliance design in the management of obstructive sleep apnoea

Source

Discipline of Dental Public Health.

Abstract

Oral appliances (OAs) are increasingly advocated as a treatment option for obstructive sleep apnoea (OSA). However, it is unclear how their different design features influence treatment efficacy. The aim of this research was to systematically review the evidence on the efficacy of different OAs on polysomnographic indices of OSA. A MeSH and text word search were developed for Medline, Embase, Cinahl, and the Cochrane library. The initial search identified 1475 references, of which 116 related to studies comparing OAs with control appliances. Among those, 14 were randomized controlled trials (RCTs), which formed the basis of this review. The type of OA investigated in these trials was mandibular advancement devices (MADs), which were compared with either inactive appliances (six studies) or other types of MADs with different design features. Compared with inactive appliances, all MADs improved polysomnographic indices, suggesting that mandibular advancement is a crucial design feature of OA therapy for OSA. The evidence shows that there is no one MAD design that most effectively improves polysomnographic indices, but that efficacy depends on a number of factors including severity of OSA, materials and method of fabrication, type of MAD (monobloc/twin block), and the degree of protrusion (sagittal and vertical). These findings highlight the absence of a universal definition of treatment success. Future trials of MAD designs need to be assessed according to agreed success criteria in order to guide clinical practice as to which design of OAs may be the most effective in the treatment of OSA.

Eur J Orthod. 2011 Jan 13.

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Subjective efficacy of oral appliance design features in the management of obstructive sleep apnea: a systematic review

Source

Discipline of Dental Public Health, Faculty of Dentistry, University of Hong Kong, Hong Kong SAR.

Abstract

INTRODUCTION:

The purpose of this study was to review available evidence on the efficacy of various oral appliances on subjectively perceived symptoms of obstructive sleep apnea syndrome.

METHODS:

A search of 4 databases was carried out. Articles were initially selected based on their titles or abstracts. Full articles were then retrieved and further scrutinized according to predetermined criteria. Reference lists of selected articles were searched for any missed publications. The finally selected articles were methodologically evaluated.

RESULTS:

Of an initial 1475 references, 14 studies were randomized controlled trials, which formed the basis of this review. Mandibular advancement devices (MADs) were compared with either inactive appliances (6 studies) or MADs with different design features (8 studies). In comparison with inactive appliances, the majority of studies showed improved subjective outcomes with MADs, suggesting that mandibular advancement is a crucial design feature of oral appliance therapy for obstructive sleep apnea syndrome.

CONCLUSIONS:

There is no 1 MAD design that most effectively influences subjectively perceived treatment efficacy, but efficacy depends on many factors including materials and method used for fabrication, type of MAD (monoblock or Twin-block), and the degree of protrusion (sagittal and vertical). This review highlights the absence of universally agreed subjective assessment tools and health-related quality of life outcomes in the literature today. Future trials of MAD designs need to assess subjective efficacy with agreed standardized tools and health-related quality of life measures to guide clinical practicitioners about which design might be most effective in the treatment of obstructive sleep apnea syndrome with oral appliances.

Am J Orthod Dentofacial Orthop. 2010 Nov;138(5):559-76.

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  1. Effects of Mandibular Posture on Obstructive Sleep Apnea Severity and the Temporomandibular Joint in Patients Fitted with an Oral Appliance
  2. Use of Watch-PAT™ in the Management of Sleep Apnea Using Oral Appliance Therapy – David Barone
  3. Use of Flow–Volume Curves to Predict Oral Appliance Treatment Outcome in Obstructive Sleep Apnea

Maternal snoring during pregnancy is associated with enhanced fetal erythropoiesis – a preliminary study

Source

Pediatric Sleep Center, Dana Children’s Hospital, Tel Aviv Souraski Medical Center, Tel Aviv University, Israel.

Abstract

OBJECTIVE AND BACKGROUND:

Snoring is common among pregnant women and early reports suggest that it may bear a risk to the fetus. Increased fetal erythropoiesis manifested by elevated circulating nucleated red blood cells (nRBCs) has been found in complicated pregnancies involving fetal hypoxia. Both erythropoietin (EPO) and interleukin-6 (IL-6) mediate elevation of circulating nRBCs. The intermittent hypoxia and systemic inflammation elicited by sleep-disordered breathing (SDB) could affect fetal erythropoiesis during pregnancy. We hypothesized that maternal snoring will result in increased levels of fetal circulating nRBCs via increased concentrations of EPO, IL-6, or both.

METHODS:

Women of singleton uncomplicated full-term pregnancies were recruited during labor and completed a designated questionnaire. Umbilical cord blood was collected immediately after birth and analyzed for nRBCs, plasma EPO and plasma IL-6 concentrations. Newborn data were retrieved from medical records.

RESULTS:

One hundred and twenty-two women were recruited. Thirty-nine percent of women reported habitual snoring during pregnancy. Cord blood levels of circulating nRBCs, EPO and IL-6 were significantly elevated in habitual snorers compared with non-snorers (p=0.03, 0.005 and 0.01; respectively). No differences in maternal characteristics or newborn crude outcomes were found.

CONCLUSIONS:

Maternal snoring during pregnancy is associated with enhanced fetal erythropoiesis manifested by increased cord blood levels of nRBCs, EPO and IL-6. This provides preliminary evidence that maternal snoring is associated with subtle alterations in markers of fetal well being.

Sleep Med. 2011 May;12(5):518-22.

 

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  1. Obstructive Sleep Apnea Screening in Pregnancy, Perinatal Outcomes, and Impact of Maternal Obesity
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  3. Aerophagia and Gastroesophageal Reflux Disease in Patients using Continuous Positive Airway Pressure: A Preliminary Observation

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

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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Influence of tongue/mandible volume ratio on oropharyngeal airway in Japanese male patients with obstructive sleep apnea

Source

Department of Fixed Prosthodontics, School of Dental Medicine, Tsurumi University, Yokohama, Japan

Abstract

OBJECTIVES:

The objective of this study was to investigate the influence on the upper airway of the size ratio of tongue and mandible (T/M ratio) with 3D reconstructed models from computed tomography (CT) data.

STUDY DESIGN:

The subjects were 40 OSA male patients. The age of the patients ranged from 25 to 77 years, with an average age of 52.6 ± 12.5 years. The body mass index (BMI) of the patients ranged from 20.1 to 35.8 kg/m(2), with an average BMI of 25.4 ± 3.4 kg/m(2). All patients underwent a full-night . The mean AHI for our subjects was 23.6 ± 18.3 events per hour. CT imaging examinations were carried out in each patient. The mandible and airway volume (between posterior nasal spine [PNS] and the tip of the epiglottis) were segmented based on Hounsfield units, automatically or semi-automatically, and their volume was calculated from the number of voxels. The tongue was carefully outlined, and the inside of the tongue was smeared on each of the axial, frontal, and sagittal planes with a semi-automatic segmentation tool. The tongue/mandible (T/M) ratio was calculated from the volume of the mandible and the tongue. In addition, we investigated simple correlations between our anatomical variables and BMI, age, and AHI.

RESULTS:

In this study, the mean tongue and mandible volume were 79.00 ± 1.06 cm(3) and 87.80 ± 1.21 cm(3), respectively. As BMI increases, tongue volume increases (P = .004) and airway volume decreases (P = .021). However, no significant correlation was found between severity of OSA (AHI) and other variables. On the other hand, there was a negative correlation between airway volume and T/M ratio (P = .046).

CONCLUSION:

As tongue volume increases with BMI, the posterior airway is affected, and thus is likely to be involved in the development of OSA; however, in this study there was no correlation between the severity of sleep apnea (AHI) and other variables in the study.

Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Feb;111(2):239-43.

 

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  1. Comparative Effects of Two Oral Appliances on Upper Airway Structure in Obstructive Sleep Apnea
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Comparative Effects of Two Oral Appliances on Upper Airway Structure in Obstructive Sleep Apnea

“Good article just published in the latest edition of Sleep. It compares a MAS device with a TSD – the results are interesting where both appliances worked, at least in the responders, but the imaging showed some differences. This data reinforces the need for tongue position and management with OAT like The Moses appliance does”

Ashley

Kate Sutherland, PhD1,2; Sheryn A. Deane, MDSc3; Andrew S.L. Chan, MD, PhD1,2,4; Richard J. Schwab, MD5; Andrew T. Ng, MD, PhD4; M. Ali Darendeliler, PhD3; Peter A. Cistulli, MD, PhD1,2,4

1Centre for Sleep Health and Research, Department of Respiratory Medicine, Royal North Shore Hospital, St Leonards, NSW, Australia; 2Woolcock Institute of Medical Research, University of Sydney, NSW, Australia; 3Department of Orthodontics, Faculty of Dentistry, University of Sydney, Sydney Dental Hospital, NSW, Australia; 4Department of Respiratory and Sleep Medicine, St George Hospital, University of New South Wales, NSW, Australia; 5University of Pennsylvania, Philadelphia, PA

Oral appliances are increasingly being used for treatment of obstructive sleep apnea (OSA). Mandibular advancement splint (MAS) mechanically protrudes the mandible, while the tongue stabilizing device (TSD) protrudes and holds the tongue using suction. Although both appliances can significantly improve or ameliorate OSA, their comparative effects on upper airway structure have not been investigated.

Design:

Cohort study.

Setting:

Sleep Investigation Unit.

Patients:

39 patients undergoing oral appliance treatment for OSA.

Interventions:

OSA patients underwent magnetic resonance imaging (MRI) of the upper airway during wakefulness at baseline and with MAS and TSD in randomized order. Treatment efficacy was determined by in a subset of 18 patients.

Measurements and Results:

Upper airway lumen and surrounding soft tissue structures were segmented using image analysis software. Upper airway dimensions and soft tissue centroid movements were determined. Both appliances altered upper airway geometry, associated with movement of the parapharyngeal fat pads away from the airway. TSD increased velopharyngeal lateral diameter to a greater extent (+0.35 ± 0.07 vs. +0.18 ± 0.05 cm; P < 0.001) and also increased antero-posterior diameter with anterior displacement of the tongue (0.68 ± 0.04 cm; P < 0.001) and soft palate (0.12 ± 0.03 cm; P < 0.001). MAS resulted in significant anterior displacement of the tongue base muscles (0.35 ± 0.04 cm). TSD responders (AHI reduction ≥ 50%) increased velopharyngeal volume more than non-responders (+2.65 ± 0.9 vs. –0.44 ± 0.8 cm3; P < 0.05). Airway structures did not differ between MAS responders and non-responders.

Conclusions:

These results indicate that the patterns and magnitude of changes in upper airway structure differ between appliances. Further studies are warranted to evaluate the clinical relevance of these changes, and whether they can be used to predict treatment outcome.

SLEEP2011;34(4):469-477.

Full text with images: http://www.journalsleep.org/ViewAbstract.aspx?pid=28089



 

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A Daytime, Abbreviated Cardio-Respiratory Sleep Study (CPT 95807-52) To Acclimate Insomnia Patients with Sleep Disordered Breathing to Positive Airway Pressure (PAP-NAP)

Barry Krakow, M.D.1,2,3; Victor Ulibarri, B.S.1,2; Dominic Melendrez, B.S.1,2; Shara Kikta2; Laura Togami2; Patricia Haynes, Ph.D.4

1Sleep & Human Health Institute, Albuquerque, NM; 2Maimonides Sleep Arts & Sciences, Ltd, Albuquerque, NM; 3Los Alamos Medical Center Sleep Laboratory, Los Alamos, NM;4Department of Psychiatry, University of Arizona, Tucson, AZ

 

Study Objectives:

To assess the impact of a daytime sleep medical procedure–the PAP-NAP–on adherence to positive airway pressure (PAP) therapy among insomnia patients with sleep disordered breathing (SDB)

Methods:

The PAP-NAP is based on Current Procedural Terminology (CPT) codes and combines psychological and physiological treatments into one procedure, which increases contact time between SDB patients and technologists to enhance PAP therapy adherence. Using a Sleep Dynamic Therapy framework, explicating SDB as a mind-body disorder, the PAP-NAP includes mask and pressure desensitization, emotion-focused therapy to overcome aversive emotional reactions, mental imagery to divert patient attention from mask or pressure sensations, and physiological exposure to PAP therapy during a 100-minute nap period. Patients treated with the PAPNAP test (n=”39)” were compared to an historical control group (n=”60)” of insomnia patients with SDB who did not receive the test.

Results:

All 99 insomnia patients were diagnosed with SDB (mean AHI 26.5 + 26.3, mean RDI 49.0 + 24.9), and all reported a history of psychiatric disorders or symptoms as well as resistance to PAP therapy. Among 39 patients completing the PAP-NAP, 90% completed overnight titrations, compared with 63% in the historical control group; 85% of the nap-tested group filled PAP therapy prescriptions for home use compared with 35% of controls; and 67% of the nap-tested group maintained regular use of PAP therapy compared with 23% of the control group. Using standards from the field of sleep medicine, the nap-tested group demonstrated objective adherence of 49% to 56% compared to 12% to 17% among controls. All studies were reimbursed using CPT 95807-52.

Conclusion:

In this pilot study, the PAP-NAP functioned as a brief, useful, reimbursable procedure to encourage adherence in insomnia patients with SDB in comparison to an historical control group that did not undergo the procedure.

http://www.aasmnet.org/jcsm/ViewAbstract.aspx?pid=27183

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  1. Randomized Controlled Trial of Variable-Pressure Versus Fixed-Pressure Continuous Positive Airway Pressure (CPAP) Treatment for Patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
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WatchPAT™ Spearheads Breakthrough of At-Home Testing

New CPT release along with pricing any day between now and 31 October.

• In October 2010, the American Medical Association to announce a new CPT (Current Procedural Terminology) code for at-home testing of obstructive apnea (OSA), which will go into effect January 1, 2011.
• Home testing and diagnosing of OSA will now become uniformly reimbursable for all physicians.
• Home testing with the WatchPAT (wrist-worn device and finger-mounted probe) delivers diagnostic accuracy at a fraction of the cost of testing, significantly lowering the cost of care.
• Several key studies indicate that patients with undiagnosed and untreated OSA utilize care resources almost two-fold higher—with heavier use of resources seen in women.
• Outpatient testing for -related breathing disorders using a wrist-worn device and finger-mounted probe was selected as one of the Top 10 Medical Innovations for 2010 by a panel of experts at the world-renowned Cleveland Clinic.

It is estimated that over 28 million Americans suffer from obstructive apnea (OSA), with approximately 20 million more going undiagnosed and untreated. The -related cost burden for undiagnosed OSA in the United States—a dangerous condition that can lead to a variety of heart ailments, stroke, and death—is estimated at $3.4 billion.

The latest figures compiled by Frost & Sullivan in 2008 show revenues in the U.S. apnea diagnostic and therapeutic market totaling approximately $1.35 billion, with a 16.2% growth rate.

WatchPAT, produced by medical device manufacturer Itamar-Medical, Ltd., is the industry leader for at-home OSA testing. WatchPAT is approved, available for all physicians as a diagnostic tool, and is poised to continue market domination once the CPT (Current Procedural Terminology) code for at-home diagnosis goes into effect January 1, 2011.

“With the new CPT code going into effect, millions of Americans suffering from apnea can now benefit from easy, low cost access to in-home testing using our WatchPAT device,” notes Dr. Dov Rubin, President and CEO of Itamar-Medical. “Patients can now take the test in the comfort of their own bed, affording them timely diagnosis and treatment for apnea, which is linked to other ailments such as heart disease, hypertension, and obesity.”

Rubin also adds, “Internists, cardiologists, and family physicians can now order the tests and get reimbursed. Using Itamar-Medical’s WatchPORTAL technology, physicians can download the information instantaneously at no extra charge and obtain a diagnosis in consultation with a local physician or via Itamar’s nationwide network of experts, with results wirelessly delivered back to a smartphone.”

WatchPAT tests outnumber the nearest competitor by 5:1, making it by far the most used at-home apnea testing device of its kind. While PSG (polysomnography) testing has been the standard of care for OSA diagnosis, it is anticipated that many labs will also be offering home testing in order to expand their services. In a July 2010 Wells Fargo Securities survey of national centers, analysts reported that 21% of centers currently offer home testing for Medicare patients and 23% offer home testing for privately insured patients, both 20% jumps from a previous survey.

Additionally, another 29% of centers plan to offer home tests in the next six months, a 19% increase since their previous survey. Moreover, 38% of the respondents indicated that they plan to increase involvement in home testing, up from 32% from the prior survey.

According to Dr. Steven Lamm, a New York internist who regularly performs WatchPAT tests on his patients, “With WatchPAT and the new CPT code, we now have the technology that will allow community doctors nationwide easy access to diagnosing apnea. Because of that, the role of the will change. testing is still extremely important, though I want to reserve it for those patients with especially complicated issues, such as , insomnia, and narcolepsy.”

Source: Itamar-Medical Ltd

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