Compromised health affects Americans in countless ways, not the least of which is sleep deprivation. The price tag in lost productivity can hit a staggering $100 billion annually thanks to medical expenses, sick leave, and property damage. The National Highway Traffic Safety Administration estimates that more than 70,000 injuries each year are related to drowsy drivers.

There are many causes of sleep disruption, and patients rarely exhibit just one. Simply addressing sleep disordered breathing (SDB) may not result in good long term sleep. Other issues can range from an inferior mattress, a disruptive sleep environment, the wrong medication, pain, incorrect positive airway pressure (PAP), and insomnia.

As a result of these staggering numbers and the increasing awareness of sleep disorders, it’s reasonable that sleep should be one of the “vital signs” of health, together with temperature, blood pressure, respiration rate, pulse, pain, and BMI (body mass index).

Adequate sleep has been defined as regularly sleeping 6-8 hours per night. Clinicians now believe that sufficient slumber is a critical factor in health and health-related behaviors across all ages. It is not enough to simply spend these hours in bed. The quality of sleep is just as, if not more important than, the quantity.

Defining Quality Sleep
How is quality of sleep defined? For the sleep specialist, “good” sleep may be defined as sleep that has normal efficiency, organized sleep architecture, and the absence of any sleep dis- ruptions. For the patient, good sleep may mean waking up in the morning feeling refreshed and not feeling sleepy during the day.

How do we currently measure “good sleep?” One way is with an in-lab PSG test, which is often necessary but also expensive. A second way is through home sleep testing (HST), although most of these devices measure parameters that only detect sleep apnea. A third, purely subjective way we measure sleep, is to simply ask patients how they are sleeping. This last approach is akin to asking them whether they feel heavier or lighter instead of having them step on a scale.

In addition, if your patients have never slept well, how do they know they slept well last night versus sleeping a bit better than the night before? This leaves us with the sleep lab but how can we expect a patient to sleep “normally” and col- lect a representative night of sleep quality when there are so many cables and equipment attached to them, not to mention we are asking them to sleep in a strange environment – with a camera watching them all night – which takes us back to home sleep testing.

Cost Effective and Objective
All of this information points to the need for a simple and objective measure of sleep quality that is cost effective enough to use on patients regularly without being specific to a particular condition, in much the same way a scale will objectively measure weight. What’s needed is a “scale” that objectively measures sleep quality or sleep health.

Enter Robert Thomas, MD, and his colleagues at the Beth Israel Deaconess Medical Center, a teaching school of Harvard Medical School, who have taken a different approach to examining sleep—seeking to objectively measure sleep quality using cardiopulmonary coupling (CPC).

The principle behind this technology is the understanding that stable NREM (non-rapid eye movement) sleep is characterized by a cardiac rhythm known as sinus arrhythmia. During stable sleep, high vagal tone modulating a healthy heart results in characteristic heart rate variability in which the heart slows and speeds up in synchrony with very regular respiration. This is what Thomas calls stable sleep.

But not all heart rate variability is synchronized with normal respiration. Repetitive sleep disruptions, which could be caused by SDB, pain, a noisy sleeping environment, periodic limb movement syndrome (PLMS), restless legs syndrome (RLS), or anxiety, to name a few, can cause the heart rate and breathing rate to vary. This bradytachyarrhythmia is well recognized in polysomnograms.

These recurring disruptions can be seen as infrequently as once every 2 to 3 minutes, or as often as 1 to 3 times every minute, so they are difficult to see in a normal PSG test. How- ever, if we look at the data in terms of frequency we can see these changes occurring over sometimes long periods of time. It’s like being too close and not seeing the forest for the trees. This is unstable sleep.

Thomas also identified that there is little overlap between stable and unstable sleep, so they can be easily displayed and differentiated from each other. This makes interpretation much easier. The concept of stable and unstable sleep is central to CPC.

The result of Roberts’ CPC is a new, low cost, patient centered system call SleepImage that measures stable vs. unstable sleep. This test-anywhere device weighs less than an ounce, sits barely detectable on the patient’s chest, and also records actigraphy, body position, ECG, and snoring. It is fully integrated with a secure website and delivers a simple and easy-to-understand “picture of sleep” that identifies stable and unstable sleep to produce an objective measure of sleep quality.

There are many practical uses for the device, and because of its simplicity, researchers have been able to expand the identification and understanding of sleep beyond conventional sleep diagnostic practices. In the sleep lab, the CPC technology can be used to help identify complex sleep apnea, a disorder that may make conventional CPAPs intolerable for patients.

As a home sleep test, the SleepImage system can be used as a very low cost screener for patients that complain of poor sleep. The SleepImage will quickly and cost effectively validate whether an in-lab PSG or some other course of action is nec- essary and more importantly allow the physician to monitor sleep quality after intervention to ensure that the patient is complying with therapy or if there is another co-morbid condition that is continuing to cause poor sleep quality.

Perhaps the most noteworthy benefit of this technology is its ease of use, requiring little or no instruction to the patient, with automated analysis and easy-to-understand graphic results.

SleepImage is FDA cleared, and affords an objective measure of sleep quality that not only provides a picture of your patient’s sleep, but also assists in tracking sleep trends over time—offering an accurate measure of the effectiveness of a given therapeutic choice. So the next time you ask pa- tients how they slept last night, why not have an objective way to validate the answer?

For more information about SleepImage you can go to SleepImage.com

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The American Academy of Pediatrics (AAP) is revising its recommendations for the diagnosis and management of obstructive sleep apnea syndrome (OSAS) in children and adolescents, according to a clinical practice guideline published online in Pediatrics.

An updated clinical practice guideline from the American Academy of Pediatrics spells out which children with obstructive sleep apnea syndrome who undergo adenotonsillectomy should be admitted as inpatients.

Read Abstract Diagnosis and Management of Obstructive Sleep Apnea Syndrome

The first recommendation in the updated guideline advises clinicians to screen for OSAS during routine health maintenance visits, because OSA in children is underdiagnosed, stated Dr. Carole L. Marcus, Director Sleep Center at the Children’s Hospital of Philadelphia and chair of the subcommittee that assembled the guideline. Parents don’t necessarily think of snoring as a sign of a serious disease. They might think it’s funny, but it’s actually a sign of illness.

The guideline also recommends that the following subset of children be admitted as inpatients after tonsillectomy: those younger than age 3; those with severe OSAS on polysomnography; those with cardiac complications of OSAS; those with failure to thrive; those who are obese; and those with craniofacial anomalies, neuromuscular disorders, or a current respiratory infection.

Another component to the guideline is the recommendation that clinicians refer patients for continuous positive airway pressure (CPAP) management if OSAS signs and symptoms persist after adenotonsillectomy or if adenotonsillectomy is not performed.

To access full article Click Here

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Insufficient sleep is linked to more aggressive form of breast cancers and the likelihood of its recurrence, a study has revealed.The study, led by Cheryl Thompson, Assistant Professor at Case Western Reserve University School of Medicine, analyzed medical records and survey responses from 412 post-menopausal breast cancer patients with Oncotype DX.

The article titled “Association of sleep duration and breast cancer OncotypeDX recurrence score” is published in Breast Cancer Research and Treament. Click Here to read Abstract

Oncotype DX is a widely utilized test to guide treatment in early stage breast cancer by predicting likelihood of recurrence.

Researchers found that women who reported six hours or less of sleep per night on average before breast cancer diagnosis had increased Oncotype DX tumor recurrence scores.

“This is the first study to suggest that women who routinely sleep fewer hours may develop more aggressive breast cancers compared with women who sleep longer hours,” Dr. Thompson said.

“We found a strong correlation between fewer hours of sleep per night and worse recurrence scores, specifically in post-menopausal breast cancer patients.

This suggests that lack of sufficient sleep may cause more aggressive tumors, but more research will need to be done to verify this finding and understand the causes of this association,” she said.

The researchers also revealed that the correlation of sleep duration and recurrence score was strong in post-menopausal women. The data suggested that sleep might affect carcinogenic pathway(s) specifically involved in the development of post-menopausal breast cancer.

Source: University Hospitals Case Medical Center

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After more than three decades in the field of neurophysiology, engineers at Cadwell Laboratories are not shy about experimenting with new technologies. Collecting data in all its guises is still the main focus at the Washington-based company, and the willingness to innovate has led the company into the realm of digital video – gone mobile.

Specifically, the company has innovated a new mobile video recording solution they call Q-Video® Mobile.

As a neurophysiology-focused company, the developers at Cadwell believe the “next channel” for data collection— particularly video—is right around the corner. The concept may be ahead of its time, but Carlton Cadwell, president of Cadwell Laboratories, told Sleep Diagnosis & Therapy that they are more than willing to wait for clinicians and government officials to catch up to the idea. The following conversation took place at the 2012 SLEEP meeting.

Why are innovative monitoring solutions growing in importance?
Carlton Cadwell, president, Cadwell Laboratories, Kennewick, WA: Monitoring EEG on patients in a hospital is labor intensive. You literally must take care of a patient 24 hours a day, and it is often a financial burden on the hospital, and insurance companies pay a lot of money.

What are some of the real world problems that physicians are encountering and what can be done?
Physicians are having problems attracting technologists to their laboratories who can do 24-hour monitoring. The technologists are specialized and difficult to find. There is demand to monitor these patients, but these patients are leaving the areas to go elsewhere for the help they need..

We can deliver a solution to physicians that is much better for them and for their patients, and it financially makes sense for everyone involved.

Patients can come into a physician’s laboratory, on a Monday for example, and one technician can set up the patient in the laboratory, send the patient home with the device—with the patient wearing the device—and the patient can hold the Q-Video Mobile camera in his or her hand.

The camera is capturing digital video 100% of the time from the moment the patient leaves the laboratory until he comes back. This is the first time that we have ever been able to capture digital video and brain wave data, in transit, on these patients.

Are physicians responding to this concept?
Physicians are immediately starting to make the connection. They realize that when their patients have clinical events, the triggers are often outside of the hospital. Historically, physicians bring patients into the hospital and patients sit there and wait. Physicians look at them and hope they will have an event.

They are in a very sterile environment, and they may simply not have that event. It makes sense to have patients collect this data in transit, in the home, in the bus station, in the vehicle, or wherever they may be.

There may be a truck driver who says, “I just am not having any abnormal events while driving my vehicle.” The Q-Video Mobile device can now concurrently capture the video while the electrophysiological and brain wave data is being captured. We can conclusively prove that they either do, or do not, have a disorder. Sleep physicians at this meeting [Associated Professional Sleep Societies (APSS)] are now starting to understand what this means to them.

What are the other issues on the minds of sleep physicians as it relates to monitoring?
Reimbursement is a big issue right now, and it is something that all our physicians are running into. In the Pacific Northwest, we have insurance companies telling our customers that you can no longer bring patients into your laboratory if they have the classic symptoms of obstructive sleep apnea. You must do a home sleep testing recording in the home, identify the apnea, and if the patient has disordered breathing, you must treat him with an auto titration device.

What are the current limitations in monitoring equipment, and why is video so important?
When physicians look at just a few squiggly lines of data, the data is essentially flat, and the physician may see something in the wave form data, but they never truly understand what is happening with the patient.

They don’t know if the head is nodding, or if it is in an unusual position, which may be crowding or obstructing the airway. They don’t know if patients are falling asleep in a chair, and what is physically happening. Our new device allows physicians to capture that video along with the wave form data when the patient is in transit, when they are at home, or in their own bedrooms at night.

What is the situation regarding reimbursement?
One of the things physicians must do in the laboratories and the clinics is try to find out how they can use this technology in their laboratories—and get reimbursement. Today’s situation resembles what we saw with CPAP many years ago.

CPAP came out in the early 1980s, and we simply had a CPAP device that would blow pressure at one level. It opened up the airway, and we were all ecstatic because we could treat these people by blowing a lot of air.

The CPAP companies went out and got reimbursement. Ultimately, Bi-PAP came out and they were also able to go out and get reimbursement. We believe that advocacy for this type of reimbursement, for this type of recording, will lead to acceptance. The opportunity is there. It is a matter influencing the reimbursement community and our government. Government officials should look at video as a channel that should be reimbursed.

Home sleep testing recordings are being reimbursed all over the United States, and we are seeing doctors get between $180 to $225 as the typical range for home sleep testing recordings.

Are Doctors satisfied with the data they are getting?
What the doctors are telling us is that in their hearts they would like to capture more data in the home. They love the EEG, they love the raw QRS signal that we get from the heart, because it tells them the condition of the heart when they examine that wave form.

But the reality is that many of these devices must be dumbed down, for lack of a better description. They must be very simple devices that the patient can put on in their home. And so the types of channels that the physician is left with are fewer and more simplified. They must read between the lines to determine what is happening in the home.

Physicians are putting more pressure on manufacturers to extract more data from these devices. We are beginning to look at different signals to determine if there is more information in these simple channels that we are collecting. We do have end users who will capture these additional channels without getting reimbursement.

Frankly, they will be losing money when compared to their colleagues down the street. These colleagues are doing fewer channels, but billing for the same studies. This is what is happening in the market right now.

What are your predictions for the video aspect of monitoring?
I think video is the channel of the future. We tend to think of saturation as a definitive channel that identifies how severe our patients are, but when you are dealing with issues related to sleep, video will be a de facto channel. It does not matter where you collect the recording, but video must be collected to really truly see what’s happening.

Is this an opinion shared by your competitors?
I think Cadwell is the first to have a device that is truly mobile, where you can hold it in your hand and capture all audio and all video that is related to what is happening.

What are the technological challenges?
The key is synchronizing audio and video to the physiological data that you are collecting. If the doctor can look at both, and compare what they are seeing in the wave form data and the video—now they can conclusively make a diagnosis on these patients.

Your neurology clients are using your products, but what are some additional advantages for pulmonologists to switch to your products?
We build an open-ended platform that is capable of multi-modalities. These modalities cover everything from a simple type 3 recording, to a type 2 recording, to even a type 1 recording. These are the ranges of complex polysomnograms.

How about the EEG side?
On the EEG side, we have routine EEGs, 24-hour EEG, and 5-day EEGs. This one platform that we sell to a traditional sleep laboratory is capable of doing all these procedures. If we are looking at just the value of the Cadwell system to a hospital, you are simply going to get a better return on investment when you buy a system like ours.

For a hospital, that is wisely and carefully spending their dollars, the ability to use the device during the day for EEGs, and at night for polysomnograms, is something that is very desirable. We do see that many of the doctors that are stepping forward and talking to us at a meeting such as the APSS are neurologists who understand the value in using this equipment during the day and during the night.

There are other revenue streams. There are spike detection programs that allow physicians to bill additional fees for reimbursement. These are all things the market is looking for to ensure a healthy and sound laboratory.

What other products do you offer?
Our sister company, Cadwell Therapeutics, offers an oral appliance [The Silent Sleep] that really makes sense for patients. If patients come in to the laboratory and they are identified as having sleep disordered breathing, the patient may insist that they will not use a CPAP. At the end of the day, you’re putting a mask on my nose and blowing air in my nose. And you expect me to go to sleep?

When these patients fail CPAP, they need an option. So what Cadwell has done is something that allows the physician, in about a 15-minute period of time, to actually fit the patient with an oral appliance that has an FDA approval for snoring and disordered breathing.

If you are patient, and you have just failed CPAP after it may have taken you a year to get the courage to come into a laboratory to finally spend that night in the laboratory and identify this problem. This is a problem that has impacted your personal life, and your work performance in some cases.

Our oral appliance is so simple to set up that we can train the medical director how to fit a patient, and the patient could be fit that morning. The patient could be leaving the laboratory with something tangible, and some degree of hope, that perhaps this device may help them.

We can titrate them in the home with multiple oral appliances. We could set one device at end-to-end, and the next device at +2mm protrusion. The patient can take these home and can try the devices. Now when the patient comes back in several weeks and says device +2 works better for me, the laboratory does a titration recording on the patient in the home with this both oral appliances, and perhaps a third appliance at +4mm

Have sleep physicians responded to the oral appliances?
They can see the tangible benefit of this device.  The patient is telling them at 2 to 3 months out that he is a candidate for this device and ready to go to a custom long-term oral appliance.

That’s a real opportunity for success story and a happy patient. And the physician can get reimbursement for the Silent Sleep oral appliance. Everyone is happy and everyone wins.

Where do you see the sleep field in the future?
I see it going to multi-modality. Laboratories need to be smart and ensure that they are generating enough revenue to support their business.

There is so much in the industry that we can do, and there are things that are within reach that we are passionate about. We believe that we can do amazing things for our customers. This little Q-Video Mobile camera that I have discussed is a good example. This little device presents an all new development platform.

What are your plans on the software front?
The technology world is getting smaller, more powerful, and able to communicate in ways that were not possible just a few years ago. Software development is more and more graphically oriented and it is easier to intuitively understand what is happening to the patient. We are innovating ways that we can reach out to patients before they ever come into the laboratory for the first time. There are innovative ways we can follow up with the patient on a daily or hourly basis. We can bridge that gap for our customers.

How do customers view Cadwell Laboratories these days?
Customers are viewing Cadwell as a total solution provider. We are delivering solutions that touch every facet of what laboratories do. That is what we are excited about, and that is where we are heading.

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To read more information Click Here

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Rajiv Doshi, MD and Philip Westbrook, MD  from Ventus Medical, San Jose, CA

Abstract

Primary snoring, defined as snoring in the absence of obstructive sleep apnea/hypopnea (OSA), is a very common problem that can significantly worsen the sleep quality of the bed partner and has been linked to important medical conditions. Health- care providers are frequently asked by their patients for snoring treatment recommendations. Unfortunately, although there are a variety of over-the-counter therapies available that claim to treat snoring, few if any have demonstrated objective clinical efficacy. This report introduces a novel, FDA-cleared device called Theravent™ Snore Therapy, which represents an important new class of snoring therapy utilizing nasal expiratory positive airway pressure (EPAP). This report summarizes the device’s mechanism of action and available clinical data.

Background

Snoring is a ubiquitous complaint of bed partners worldwide and leads to many patient requests for treatment recommendations. Snoring is the audible signature of increased resistance to airflow during sleep, and is part of a spectrum of sleep- disordered breathing conditions that includes OSA.

The sound of snoring is created by turbulent airflow-induced vibration of tissues in the collapsible portion of the upper airway. Any unsupported tissue lining the upper airway down to the vocal cords can vibrate and make noise. This includes the soft palate, uvula, pharyngeal walls and tongue – a diffuse sound generator that renders successful local treatment difficult.¹ Sleep normally reduces the activity of the dilating musculature that otherwise opens and stabilizes the pharyngeal passageway during inspiration.² If the pharyngeal passageway is abnormally narrow or floppy, then airflow into the lungs must speed up, further lowering the pressure in the airway, creating a turbulence which vibrates soft tissue.³ The vibrating tissue creates the harsh noise of snoring.

Epidemiology

In the United States, habitual snoring has a reported prevalence of 34% to 44% in men and 15% to 28% in women. Higher prevalence of snoring was reported in two Canadian studies, in which 71-86% of men and 51-57% of women were found to snore.¹ These differences in reported prevalence reflect the subjective nature of reported snoring and different methods used to gather the information. The correlation between self-reported snoring and objectively measured snoring can be poor.⁴

Studies by Young5 and Bliwise⁴ were rigorous and large, so their estimate that about one third of the adult population in the United States snores most nights of the week is widely accepted. However, a recent prevalence report in the United States suggested a higher rate of snoring: 59% of 1506 respondents (both sexes) snored, 54% at least 3 nights per week, and 40% every night or almost every night.⁶ This apparent increase in snoring prevalence might reflect the increase in obesity prevalence in the United States as obesity is a risk factor for snoring. Indeed, this trend could be expected to continue.

Snoring is more prevalent in men for reasons that are still not fully explained. The major risk factors for snoring are similar to those for OSA, such as obesity and increased neck circumference. In addition, a number of studies have reported that the prevalence of snoring decreases after the age of 70, a finding that is somewhat counterintuitive. Poor hearing acuity in the elderly, fewer elderly with bed partners, or diminished survival of snorers have been offered as possible explanations.

The Basis for Treatment

Healthcare providers may need to decide whether snoring should be treated. Many patients may ask for therapy to appease a bed partner whose sleep may be disturbed. Frequently, snoring can contribute to relationship problems. Further, there are studies that suggest that snoring should be treated for other reasons beyond trying to improve the sleep of the bed partner.

Daytime Sleepiness

In some individuals, snoring may be associated with episodes of airway obstruction that increase the drive to breathe and cause frequent arousals, but do not cause enough desaturation to meet the usual definition of a hypopnea. This has been called the upper airway resistance syndrome, and the events termed “respiratory effort related arousals” (RERAs) or “flow limitation events” (FLEs). In these patients, snoring may be associated with excessive daytime sleepiness and prescribed treatment with PAP (positive airway pressure) can improve sleepiness and daytime function.

Hypertension

In an extensive review, Hoffstein documented that 14 of 19 studies examining the association between snoring and hypertension found that snoring was not an independent risk factor.⁷ The recent Sleep Heart Health Study of over 6000 individuals found no significant association between self-reported snoring and hypertension.⁸

Coronary Artery Disease

In spite of the scarcity of evidence linking non-apneic snoring to hypertension, a possible association between habitual snoring and coronary artery disease is not easily dismissed. A recent, large (>12,000 patients) Hungarian study found that reported loud snoring with breathing pauses, but not quiet snoring, was a significant independent risk factor for acute myocardial infarction, as well as hypertension and stroke.⁹

Cerebrovascular Disease

For years the epidemiologic data suggesting an association between habitual snoring and cerebrovascular disease was explained by assuming that self-reported snoring was just a surrogate for OSA. The report by Lee and colleagues in 2008 that heavy snoring independently increases the risk of carotid artery atherosclerosis, likely due to direct tissue vibration, has challenged the old explanation.¹⁰ The finding that peri-carotid tissue vibrations similar to that resulting from loud snoring damaged the lining of the carotid arteries in rabbits supports the hypothesis that snoring-induced vibration is the culprit.¹¹

Treatment Options

Several non-prescription treatments have been proposed for snoring, including position-limiting devices (to keep patients off their back), various drugs, oral sprays, nasal dilators, chin straps and, more recently, snore-activated alarms. The efficacy studies of these are often characterized by enthusiastic subjective reports but poor objective verification.

Behavioral Therapy

Obesity is a major risk factor for snoring, so for overweight and obese snorers, diet and exercise should be the first treatment recommended. Unfortunately, dietary weight loss is seldom maintained and there is little non-anecdotal evidence that weight loss reduces snoring. Because the supine position promotes upper airway collapse, and changing from the supine to a non-supine sleep position may decrease snoring, position restriction devices including head positioning pillows have been popular. The evidence that these devices work or that patients continue to use them over time is sparse. Alcohol consumption can promote snoring so avoidance prior to bedtime should be recommended.

Medical Therapy

Two endocrine diseases, hypothyroidism and acromegaly, can cause sleep apnea and snoring, and should be treated if identified. Nasal decongestants/steroids/lubricants are available over-the-counter and are touted as treatments for snoring. There is evidence that allergic nasal congestion can cause snoring, and presumably other causes of nasal mucosal inflammation can do the same. A brief trial of nasal spray decongestant or steroid is reasonably safe and relatively inexpensive to try. There is little objective evidence that nasal lubricants work nor is there reliable evidence that dietary supplements improve snoring.¹²

Nasal Dilators

Perhaps the most popular non-prescription therapy for snoring is nasal dilators. Traditional nasal dilators can expand and hold open the nasal valves reducing inspiratory flow resistance in a way that is quite noticeable to the awake wearer. External nasal dilator strips (ENDS) and internal nasal dilators (IND) have only equivocal evidence of efficacy.¹²,¹³

Oral Appliances

Oral appliances are a recommended prescription treatment for non-apneic snoring. Almost without exception, studies where some objective measure of snoring change is reported confirm a significant improvement in snoring.¹⁴ However, such appliances can lead to excessive salivation and dentition change that can limit their use and require regular follow up with the dentist. Oral appliances do not completely eliminate snoring in everyone and because they may require custom fitting by a dentist, they can be expensive to try.

Continuous Positive Airway Pressure (CPAP)

CPAP eliminates snoring in the vast majority of users but is viewed as being very cumbersome by many users. CPAP acceptance and adherence can be low in patients with OSA, and considerably worse in patients with simple snoring.

Surgical Therapy

Though invasive and painful, surgery can be attractive to some patients because it offers the chance for a “permanent” cure, and some patients do benefit from this treatment. Surgery for snoring is essentially the same as surgery for OSA, and can involve the nose, palate, tongue, and pharyngeal walls but usually not the facial skeleton. Nasal surgery improves snoring only in a minority of patients.1 Pharyngeal surgery, such as uvulopalatopharyngoplasty alone or with tongue base reduction has had mixed success with reported improvement varying from 22% to 92% depending on the length of follow-up. A recent systematic review of surgery for snoring found that there was limited reliable evidence of a beneficial effect.¹⁵

About Theravent (Nasal EPAP)

The newest class of snoring treatment is nasal expiratory positive airway pressure (EPAP). It is available over-the-counter under the tradename Theravent Snore Therapy (Ventus Medical, Inc., San Jose, California). Theravent is FDA cleared with the intended use of reducing or eliminating snoring. Theravent utilizes proprietary microvalves set within a medical-grade hypoallergenic adhesive patch which surrounds the user’s nostrils.

During inhalation, the microvalves open, allowing for relatively unrestricted airflow. However, during exhalation, the microvalves close, creating resistance to airflow and thus creating EPAP (Figure 1, Figure 2).

Nasal EPAP Precedent

Nasal EPAP was demonstrated to treat sleep disordered breathing, namely OSA, as early as 1983 by Mahadevia.¹⁶ Yet, it was not until 2008 that the first EPAP device was FDA cleared and became commercially available to treat OSA, under the tradename Provent® Therapy (Ventus Medical, San Jose, California). This prescription-only device has been evaluated in seven published studies^17–23 and has been shown to be clinically effective in treating mild, moderate and severe OSA and in reducing snoring in patients with OSA. Physiologically, EPAP, when provided at resistance levels that can treat OSA, has been shown to increase pressure in the airway until the start of the next inspiration.20

Though the exact mechanism of action is still not certain, three likely mechanisms have emerged in clinical studies in patients with OSA:

1. Positive end-expiratory pressure (PEEP) leading to increased end-expiratory lung volumes (or FRC) that increases longitudinal traction on the pharynx, making it less collapsible (“tracheal tug”).²⁰
2. Dilatation of the upper airway that carries over until the start of the next inspiration.²⁰
3. Mild hypercapnia due to reduced ventilation leading to increased respiratory drive to the upper airway.²³ Importantly, in three studies of the Provent EPAP device in patients with OSA, the percentage reduction in snoring duration was 65%, 58% and 74% using objective measures (vibratory probe on the neck or a decibel meter).¹⁷,¹⁸,²² One study demonstrated that 83% of OSA patients had a reduction in snoring, assessed using an vibratory probe on the neck.¹⁷ Several of these patients had a complete elimination of their snoring.

As described earlier, a novel over-the-counter device has become available for the treatment of snoring, utilizing EPAP, albeit at a much lower resistance than the Provent EPAP device for OSA. This device, known as Theravent Snore Therapy, has been studied in three separate clinical studies in multiple resistances, which have demonstrated both objective and subjective improvements in snoring.

Clinical Studies Studying Theravent nasal EPAP for the Treatment of Primary Snoring

Objective Clinical Study

A prospective, randomized, single-center trial used decibel meters to evaluate the effectiveness of the Theravent device in a population of primary snorers (without OSA). Forty-nine patients were evaluated on control nights (with no therapy), as well as on Theravent and on commercially available external nasal dilator strips. In addition, patients and their bed partners maintained daily logs and completed a survey at the conclusion of the study.

Methods

Inclusion criteria included age of at least 18, presence of a bed partner, and nightly snoring. Exclusion criteria included diagnosis of OSA, witnessed cessation of breathing or gasps for air while sleeping, diagnosis of insomnia, history of respiratory failure, history of any other unstable and/or untreated serious medical conditions, and history of allergic reaction to acrylic-based adhesives (such as those found in BAND-AIDS). Patients judged to have a high risk for OSA were screened out of the study either during the phone screening or at physical exam. Patient demographics are summarized in Table 1.

During each night of the study, the patient wore the ARES Unicorder portable device (Advanced Brain Monitoring, Carlsbad, CA), a validated portable monitor for sleep disordered breathing.²⁴,²⁵ The portable monitor recorded snoring duration (minutes spent > 40 decibels (dB)), pulse rate, SpO2, head position, and respiratory effort. The snoring microphone was located in the recording device on the forehead, placing it at a fixed distance from the source of snoring. Scoring of time spent snoring > 40 dB was accomplished using the automated ARES software. The choice of > 40dB as a snoring threshold was made because that level was in the mid-range (>30, >40, >50 dB) of the reported snoring loudness levels reported with the ARES microphone, and these levels seemed consistent with the Leq levels reported in snorers by Wilson et al.²⁶ Prior to the generation of the final sleep report for each night, the studies were examined for anomalies such as excessive background noise and off-head alarms. A minimum of a 50% reduction in the percent of time spent snoring > 40 dB (compared to the control night) was used as the primary objective measure of device success. Paired t-test comparison between groups was achieved by comparing the percent time snoring.

Two bed partner reported outcome measures were also used to gauge effectiveness of the snoring treatments. Every morning, in their daily logs, bed partners were asked to assess the volume and duration of their partner’s snoring the night before. Answers were provided by visual analog scale (VAS) and later converted to a scale of 0-100. A score of 0 indicated very loud or constant snoring and a score of 100 indicated no snoring.

Results

Forty-nine patients were enrolled in the study. Objective snoring analysis was completed on the 46 patients with sufficient portable monitoring data during both control and treatment nights. Subjective (bed partner) analysis was completed on 48 patients whose daily log data were available.

The mean percent of sleep time snoring > 40 dB, the primary endpoint of the study, was significantly reduced for Theravent compared to control from 19.7% to 12.3% (p<0.001). For the external nasal strips, snoring was reduced from 19.7% to 18.2% which was not significantly different compared to control (p=0.309) (Table 2). Fifty percent (23 of 46) of patients using Theravent had their snoring duration reduced by at least 50%. Among these responders to Theravent, the mean reduction in snoring was 76% according to the decibel meter (Table 3). Only 9 of 46 (20%) of patients using external nasal strips achieved at least a 50% reduction in snoring.

Data reported in daily logs indicated that bed partners experienced significantly less sleep disruption and reported a highly significant decrease in both snoring volume (p<0.001) and snoring duration (p<0.001) compared to control (Table 4).

Eight adverse events (none serious) were reported that were deemed possibly related to Theravent, most relating to difficulties adjusting to breathing through the device.

Conclusion

Theravent nasal EPAP significantly reduced snoring duration compared to control (p<0.001) using a decibel meter in the home setting. Responders to Theravent achieved an average snoring reduction of 76%. Furthermore, bed partners reported highly significant reductions in snoring volume (p<0.001) and snoring duration (p<0.001) compared to control during this in-home trial.

Subjective Clinical Studies

Two subsequent studies of Theravent in a not yet commercially available resistance level demonstrated high levels of bed partner satisfaction and snoring reduction. The first study was a prospective customer preference study with seven nights of in-home evaluation of 43 frequent snorers and their bed partners. The end-of-study survey responses demonstrated that 86% of bed partners found that the device reduced snoring. The second study also was a prospective customer preference study with seven nights of in-home evaluation involving 46 frequent snorers and their bed partners. In this study, 89% of bed partners reported that the device reduced snoring and 83% of all subjects expressed interest in continuing to use the device at the end of the study.

Using Theravent in the Real World: Implications for Healthcare Providers

It may take several days for patients to acclimate to wearing and breathing through the Theravent nasal EPAP device. The healthcare provider should let the patient know:

1. That the first few nights using Theravent nasal EPAP may be uncomfortable for some patients, but that comfort improves over the ensuing days
2. To remove the device during initial nights if he/she has difficulty sleeping and to try again the following night
3. To breathe out through the mouth while awake and falling asleep

Further, healthcare providers should exclude patients diagnosed with OSA and those with the following conditions:

• A cold, sinus or ear infection or perforated eardrum
• Severe breathing problems (including emphysema)
• Severe heart problems
• Very low blood pressure

Summary

Snoring is a very common condition that historically has had limited, clinically proven treatment options. The Theravent device is a novel, FDA cleared, over-the-counter treatment option for snoring that utilizes nasal EPAP to maintain patency of the upper airway to reduce or eliminate snoring. Data from a study of 49 patients demonstrated statistically significant improvements in snoring duration based on objective monitoring data from a decibel meter and statistically significant improvements in snoring duration and volume based on bed partner assessment. Theravent represents an important new option for healthcare providers to recommend to their patients to treat snoring.

References

1. Hoffstein V. Snoring and Upper Airway Resistance. In Kryger MH, Roth T, Dement WC. (eds): Principles and Practice of Sleep Medicine 4th Ed. Philadelphia. Elsevier Saunders, 2005, pp.1001–1012.
2. Skatrud JB, Dempsey JA. Airway resistance and respiratory muscle function in snorers during NREM sleep. J Appl Physiol 1985;59:328–335.
3. Liistro G, Stanescu DC, Veriter C, et al. Pattern of snoring in obstructive sleep apnea patients and in heavy snorers. Sleep 1991;14:517–525.
4. Bliwise DL, Nekich JC, Dement WC. Relative validity of self-reported snoring as a symptom of sleep apnea in a sleep clinic population. Chest 1991;99:600–608.
5. Young T, Palta M, Dempsey J, et al. The occurrence of sleep- disordered breathing among middle-aged adults. N Engl J Med 1993; 328:1230–1235.
6. Hiestand DM, Britz P, Goldman M, et al. Prevalence of symptoms and risk of sleep apnea in the US population. Chest 2006;130: 780–786.
7. Hoffstein V. Snoring. Chest 1996;109:201–222.
8. Nieto FJ, Young TB, Lind BK, et al. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community- based study. JAMA 2000;2831829–1836.
9. Dunai A; Keszei AP; Kopp MS; et al. Cardiovascular disease and health-care utilization in snorers: a population survey. Sleep 2008;31:411–416.
10. Lee S, Amis TC, Byth K, et al. Heavy snoring as a cause of carotid artery atherosclerosis. Sleep 2008;31:1207–1213.
11. Cho JG; Witting PK, Verma M, et al. Tissue vibration induces carotid artery endothelial dysfunction: a mechanism linking snoring and carotid atherosclerosis?. Sleep 2011;34(6):751–757.
12. Meoli AL, Rosen CL, Kristo D, et al. Nonprescription treatments of snoring or obstructive sleep apnea: an evaluation of products with limited scientific evidence. Report of the Clinical Practice Review Committee, American Academy of Sleep Medicine. Sleep 2003;26:619–624.
13. Michaelson PG, Mair EA. Popular snore aids: Do they work? Otolaryngol Head Neck Surg 2004; 130: 649–658.
14. Hoffstein V. Review of oral appliances for treatment of sleep- disordered breathing. Sleep Breath 2007;11:1–22.
15. Franklin KA, Anttila H, Axelsson S, et al. Effects and side-effects of surgery for snoring and obstructive sleep apnea – a systematic review. Sleep 2009;32:27–36.
16. Mahadevia AK, Onal E, Lopata M. Effects of expiratory positive airway pressure on sleep-induced respiratory abnormalities in patients with hypersomnia-sleep apnea syndrome. Am Rev Respir Dis 1983;128:708–711.
17. Colrain IM, Brooks S, Black J. A pilot evaluation of a nasal expiratory resistance device for the treatment of obstructive sleep apnea. J Clin Sleep Med 2008;4:426–433.
18. Rosenthal L, Massie CA, Dolan DC, et al. A Multicenter, prospective study of a novel nasal EPAP device in the treatment of obstructive sleep apnea: efficacy and 30-day adherence. J Clin Sleep Med 2009;5:532–537.
19. Walsh JK, Griffin KS, Forst E, et al, A convenient expiratory positive airway pressure nasal device for the treatment of sleep apnea in patients non-adherent with continuous positive airway pressure. Sleep Medicine 2011:12:147–152.
20. Patel AV, Hwang D, Masdeu M, et al. Predictors of response to a nasal expiratory resistor device and its potential mechanisms of action for treatment of Obstructive Sleep Apnea (OSA). J Clin Sleep Med 2011:7:13–22.
21. Berry RB, Kryger MH, Massie CA. A Novel nasal expiratory positive airway pressure (EPAP) device for the treatment of Obstructive Sleep Apnea: A Randomized Controlled Trial. Sleep 2011;34(4):479–485.
22. Kryger. MH, Berry RB, Massie CA. Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA). J Clin Sleep Med 2011; 7:5:449–453.
23. Braga CW, Chen Q, Burschtin O, et al. Changes in lung volume and upper airway using MRI during application of nasal expiratory positive airway pressure in patients with sleep disordered breathing. J Appl Physiol 2011;111:1400–1409.
24. Ayappa I, Norman RG, Seelall V, et al. Validation of a self-applied unattended monitor for sleep disordered breathing. J Clin Sleep Med 2008;4(1):26–37.
25. Westbrook PR, Levendowski DJ, Cvetinovic M, et al. Description and validation of the apnea risk evaluation system: a novel method to diagnose sleep apnea-hypopnea in the home. Chest 2005;128:2166–2175.
26. Wilson K, Stoohs RA, Mulrooney TF, et al. The snoring spectrum. Acoustic assessment of snoring sound intensity in 1,139 individuals undergoing polysomnography. Chest 1999;115:762–770.

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New research shows that a lack of sleep is a growing health problem around the world. Sleeplessness has been linked to such chronic illnesses as cardiovascular disease and diabetes. Lack of sleep is not just a problem in developed nations. It’s getting just as bad in developing countries as well.

Researchers at the University of Warwick Medical School in Coventry, England conducted the study. “Our purpose was to look at the existing data from eight different countries from both Africa and Asia. We came to estimate the prevalence of self-reported sleep problems across eight different populations. And also we tried to examine potential correlates of sleep problems in these populations,” said lead author Dr. Saverio Stranges.

The research was conducted in Ghana, Tanzania, South Africa, India, Bangladesh, Vietnam, Indonesia and an urban area of Kenya. The study estimates 150 million adults in developing countries are suffering from sleep-related problems.

“There is biological evidence supporting the notion that sleep deprivation, for example, may impair important physiological functions, including, for example, appetite or neuro-regenerative responses. And also have an impact on the immune system, which may actually explain the association of sleep with occurrence of many chronic diseases,” he said.

New research shows that a lack of sleep is a growing health problem around the world. Sleeplessness has been linked to such chronic illnesses as cardiovascular disease and diabetes. Lack of sleep is not just a problem in developed nations. It’s getting just as bad in developing countries as well.

The study “Sleep problems: An Emerging Global Epidemic” is published in the Journal SLEEP

Click here to read abstract

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The post Lack of Sleep Diminishes Perfomance Quality appeared first on Sleep Diagnosis and Therapy.

CleveMed, a leader in Home Sleep Testing equipment and services, recently announced that they have received a newly issued patent (U.S. Patent No. D663,430 S) from the United States Patent Office for an application covering the design for a sleep diagnostic device which is currently used for SleepView®. SleepView allows patients to be tested for obstructive sleep apnea (OSA) in the comfort, convenience and privacy of their own home. SleepView is currently the smallest, lightest home sleep testing device that meets the American Academy of Sleep Medicine channel set as described by the Portable Monitoring Task Force in 2007. The design was made to be patient friendly for self-placement and sleeping while wearing the device.

“We kept the patient in the forefront as we developed this design. A home sleep system must be easy and comfortable for the patient to wear,” said Sarah Weimer Director of sleep products. “Our goal for the technology is to improve patient access and reduce health care costs for millions of sleep apnea patients who remain undiagnosed and untreated.”

Click here for full announcement

The post CleveMed Obtains Design Patent for Sleep Diagnostic Device appeared first on Sleep Diagnosis and Therapy.

It is well known that there are many causes of sleep disruption through the night, and patients rarely exhibit just one. Simply addressing sleep disordered breathing (SDB) may not result in good long term sleep. Other issues can range from an inferior bed, a disruptive sleep environment, incorrect medication, pain, incorrect positive airway pressure (PAP), insomnia, and many more.

For the nearly 70 million Americans who suffer from sleep disorders, sleep offers little chance to rest. In the United States, sleep deprivation and disorders carry a price tag of more than $100 billion annually in lost productivity, medical expenses, sick leave, and property damage. The National Highway Traffic Safety Administration estimates that 71,000 injuries each year are related to drowsy drivers.

As a result of these staggering numbers and the increasing awareness of sleep disorders, it has been suggested that sleep should be one of the “vital signs” of health together with temperature, blood pressure, respiration rate, pulse, pain, and BMI (body mass index).

Adequate sleep has been defined as regularly sleeping 6-8 hours per night. Clinicians now believe that sufficient slumber is a critical factor in health and health-related behaviors across all ages. It is not enough to simply spend these hours in bed. The quality of sleep is just as, if not more important than, the quantity.

How is quality of sleep defined? For the sleep specialist, “good” sleep may be defined as sleep that has normal efficiency, organized sleep architecture, and the absence of any sleep disruptions. For the patient, good sleep may mean waking up in the morning feeling refreshed and not feeling sleepy during the day.

How do we currently measure “good sleep?” One way is with an in-lab PSG test, which is often necessary but also expensive. A second way is through home sleep testing (HST), although most of these devices measure parameters that only detect sleep apnea. A third, purely subjective way we measure sleep, is to simply ask patients how they are sleeping. This last approach is akin to asking them whether they feel heavier or lighter instead of having them step on a scale.

In addition, if your patients have never slept well, how do they know they slept well last night versus sleeping a bit better than the night before? This leaves us with the sleep lab but how can we expect a patient to sleep “normally” and collect a representative night of sleep quality when there are so many cables and equipment attached to them, not to mention we are asking them to sleep in a strange environment – with a camera watching them all night – which takes us back to home sleep testing.

All of this information points to the need for a simple and objective measure of sleep quality that is cost effective enough to use on patients regularly without being specific to a particular condition, in much the same way a scale will objectively measure weight. What’s needed is a “scale” that objectively measures sleep quality or sleep health.

Enter Robert Thomas, MD, and his colleagues at the Beth Israel Deaconess Medical Center, a teaching school of Harvard Medical School, who have taken a different approach to examining sleep—seeking to objectively measure sleep quality using cardiopulmonary coupling (CPC).

The principle behind this technology,  is the understanding that stable NREM (non-rapid eye movement) sleep is characterized by a cardiac rhythm known as sinus arrhythmia. During stable sleep, high vagal tone modulating a healthy heart results in characteristic heart rate variability in which the heart slows and speeds up in synchrony with very regular respiration. This is what Thomas calls stable sleep

But not all heart rate variability is synchronized with normal respiration. Repetitive sleep disruptions, which could be caused by SDB, pain, a noisy sleeping environment, periodic limb movement syndrome (PLMS), restless legs syndrome (RLS), or anxiety, to name a few, can cause the heart rate and breathing rate to vary. This bradytachyarrhythmia is well recognized in polysomnograms.

These recurring disruptions can be seen as infrequently as once every 2 to 3 minutes, or as often as 1 to 3 times every minute, so they are difficult to see in a normal PSG test. However, if we look at the data in terms of frequency we can see these changes occurring over sometimes long periods of time. It’s like being too close and not seeing the forest for the trees. This is unstable sleep.

Thomas also identified that there is little overlap between stable and unstable sleep, so they can be easily displayed and differentiated from each other. This makes interpretation much easier. The concept of stable and unstable sleep is central to CPC.

The result of Roberts’ CPC is a new, low cost, patient centered system call SleepImage  that measures stable vs. unstable sleep. This test-anywhere device weighs less than an ounce, sits barely detectable on the patient’s chest, and also records actigraphy, body position, ECG, and snoring. It is fully integrated with a secure website and delivers a simple and easy-to-understand “picture of sleep” that identifies stable and unstable sleep to produce an objective measure of sleep quality.

There are many practical uses for the device, and because of its simplicity, researchers have been able to expand the identification and understanding of sleep beyond conventional sleep diagnostic practices. In the sleep lab, the CPC technology can be used to help identify complex sleep apnea, a disorder that may make conventional CPAPs intolerable for patients.

As a home sleep test, the SleepImage system can be used as a very low cost screener for patients that complain of poor sleep. The SleepImage will quickly and cost effectively validate whether an in-lab PSG or some other course of action is necessary and more importantly allow the physician to monitor sleep quality after intervention to ensure that the patient is complying with therapy or if there is another co-morbid condition that is continuing to cause poor sleep quality.

Perhaps the most noteworthy benefit of this technology is its ease of use, requiring little or no instruction to the patient, with automated analysis and easy-to-understand graphic results.

SleepImage is FDA cleared, and affords an objective measure of sleep quality that not only provides a picture of your patient’s sleep, but also assists in tracking sleep trends over time—offering an accurate measure of the effectiveness of a given therapeutic choice. So the next time you ask patients how they slept last night, why not have an objective way to validate the answer?

Click for more information about SleepImage.