Home Sleep Testing Continues its Momentum

Helen Driver, PhD, RPSGT, believed home sleep testing was probably a viable mechanism to discover sleep apnea, but she needed to find out for herself.

Relinquishing control of crucial diagnostics has never been a favored practice of clinicians. Instead, dedicated sleep technologists prefer to monitor physiological variables while administering a gold standard polysomnography.

Helen Driver, PhD, RPSGT, DABSM, shares the same instinct, but the veteran of more than two decades in the sleep world knows that labs are not right for everyone. Demand is increasing, and some patients simply have no interest in spending the night in a laboratory—whether it’s comfortable or not.

As coordinator of the Sleep Disorders Laboratory at Kingston General Hospital and Queen’s University, Ontario, Canada, Driver sees patients young and old in an environment where little is left to chance. “There is no doubt that some people do better with the additional care they get in the lab,” says Driver, who works under the Queen’s University Department of Medicine umbrella. “In the lab, patients get the one-on-one attention that ensures everything is being properly recorded. Physicians know what their patients need and want, and being in a lab patients get that additional education.”

With so many patients out there, Driver and her colleagues believed that home sleep testing could be a valuable screening modality. After doing their own studies, that belief now has data to back it up. Researchers followed up an in-laboratory validation study of a level III portable monitoring device called the MediByte®, from Canada-based Braebon Medical Corp (Driver et al 2011), with at-home studies (Pereira et al 2011).

Specifically, 150 patients recruited from the Kingston General Hospital completed validated questionnaires after wearing the MediByte level III portable monitor. The study compared findings from the home study with in-laboratory polysomnography for screening of obstructive sleep apnea (OSA).

Downloaded Medibyte data included oximetry, nasal pressure airflow, and respiratory inductance plethysmography manually scored by an experienced scorer who was blind to in-lab PSG results. At a diagnostic threshold AHI of 10 (based on in-lab polysomnography), compared with any of the questionnaires, the portable monitor had a slightly lower sensitivity (79%) indicating a true-positive result for OSA. There was greater specificity (88%) referring to the proportion of patients without OSA who had a negative test result (true-negative) on the portable monitor. High specificity is important because of the potential costs associated with following-up false-positive cases.

The sensitivity and specificity for each of the questionnaires for an AHI of 10 was as follows: Sleep Apnea Clinical Score 89%, 52%; Stop-Bang 89%, 24%; Berlin 89%, 28%.

For a diagnostic threshold AHI of 15, the sensitivity and specificity were as follows: MediByte 79%, 94%; Sleep Apnea Clinical Score 91%, 50%; Stop-Bang 91%, 28%; Berlin 91%, 28%.

The understanding is that the device is used in the home setting for a certain clinical population. As such, Driver and her fellow researchers were open to seeing how it went. “My own instinct, being lab based, is that you can’t get any measure that is as good as somebody actually watching,” says Driver. “More data is optimal. But this is a surrogate, and we were hopeful it would be accurate, and it turned out to be that way given the caveats of no additional measures that improve the reliability.”

Fundamental Changes
Driver is hopeful that home sleep testing will continue to be used in a setting where there is access to good clinical consultation, and an in-lab assessment if needed. “Home sleep testing can be a useful adjunct for follow-up as part of comprehensive care,” she says. “We must change the way we have been practicing, and our lab is included in that. We must change the way we practice sleep medicine to improve efficiencies in diagnosis of sleep disorders, and specifically OSA.”

Part of that new way of thinking includes a level of trust that goes beyond the lab walls. For example, if a patient’s livelihood is at stake (such as trucking), will he actually wear the device? Or could the device be used on a family member with no sleep problems?

The public safety concerns are real, and Driver concedes that the issues must be confronted. One thing is certain; education will remain crucial for compliance. “If people take home testing devices, someone should still show patients how to use and set them up, and review the raw data,” she says. “Ultimately, home sleep testing can shorten wait times and increasing availability of testing, which can lead to a huge improvement for sleep laboratories.”

Acceptance a Done Deal?
Acceptance of home sleep testing depends on whom you ask. “Confidence levels are still very mixed when it comes to home sleep testing,” admits Driver. “It depends on the background from which you come. If you are very familiar with the way we do studies in the lab, you have a good understanding of the gold standard. Those who come from a dental background are familiar and open to using home sleep screening devices. These devices should be used in conjunction with good clinical practice and follow-up. This is a good technology that is practical and useful for patients, and that is our overriding concern.”

Not surprisingly, if the test is not properly interpreted, and the therapy is not appropriately implemented, there are problems. In the context of Driver’s study, gender was also a consideration. “Women are more likely to have upper airway resistance, so it’s a more subtle flow limitation,” says Driver. “It might cause an arousal or an awakening, rather than a desaturation greater than 3%. So that is one limitation of a home testing study—it relies on oxygen desaturation. In the lab with some of the more subtle types, we see it manifested in the EEG.”

  1. Driver, H.S. Bjerring, K.A., Toop F., Pereira E., Stewart, S.C., Munt, P. & Fitzpatrick, M.F. (2011) Validation of the MediByte® Type 3 Portable Monitor compared with Polysomnography for Screening of Obstructive Sleep Apnea. Canadian Respiratory Journal, 18 (3): 137-143
  2. Pereira E, Driver H, Stewart S, Fitzpatrick M. Validated questionnaires and an ambulatory monitor in the diagnosis of obstructive sleep apnea. Sleep Medicine 2011;12, Suppl. 1: S12

Short Sleep Duration in many U.S. Workers – CDC Report

Insufficient sleep can have serious and sometimes fatal consequences for fatigued workers and others around them . For example, an estimated 20% of vehicle crashes are linked to drowsy driving.

The National Sleep Foundation recommends that healthy adults sleep 7–9 hours per day. To assess the prevalence of short sleep duration among workers, CDC analyzed data from the 2010 National Health Interview Survey (NHIS). The analysis compared sleep duration by age group, race/ethnicity, sex, marital status, education, and employment characteristics. Overall, 30.0% of civilian employed U.S. adults (approximately 40.6 million workers) reported an average sleep duration of ≤6 hours per day.

The prevalence of short sleep duration (≤6 hours per day) varied by industry of employment (range: 24.1%–41.6%), with a significantly higher rate of short sleep duration among workers in manufacturing (34.1%) compared with all workers combined. Among all workers, those who usually worked the night shift had a much higher prevalence of short sleep duration (44.0%, representing approximately 2.2 million night shift workers) than those who worked the day shift (28.8%, representing approximately 28.3 million day shift workers).

An especially high prevalence of short sleep duration was reported by night shift workers in the transportation and warehousing (69.7%) and health-care and social assistance (52.3%) industries. Targeted interventions, such as evidence-based shift system designs that improve sleep opportunities and evidence-based training programs on sleep and working hours tailored for managers and employees (4), should be implemented to protect the health and safety of workers, their coworkers, and the public.

Source: CDC MMWR Weekly Report

Symptoms that Effect A.D.H.D. in Children Might be from a Sleep Disorder

Diagnoses of A.D.H.D among children have increased dramatically in recent years, rising 22% from 2003 to 2007, according to the Centers for Disease Control and Prevention. But many experts believe that this may not be the epidemic it appears to be.

Many children are given a diagnosis of A.D.H.D, researchers say, when in fact they have another problem: a sleep disorder, like sleep apnea. The confusion may account for a significant number of A.D.H.D. cases in children, and the drugs used to treat them may only be exacerbating the problem.

“No one is saying A.D.H.D. does not exist, but there’s a strong feeling now that we need to rule out sleep issues first,” said Dr. Merrill Wise, a pediatric neurologist and sleep medicine specialist at the Methodist Healthcare Sleep Disorders Center in Memphis.

The symptoms of sleep deprivation in children resemble those of A.D.H.D. While adults experience sleep deprivation as drowsiness and sluggishness, sleepless children often become wired, moody and obstinate; they may have trouble focusing, sitting still and getting along with peers.

The latest study “Sleep-Disordered Breathing in a Population-Based Cohort: Behavioral Outcomes at 4 and 7 years (click here to view Abstract)” suggesting a link between inadequate sleep and A.D.H.D. symptoms appeared last month in the journal Pediatrics. Researchers followed 11,000 British children for six years, starting when they were 6 months old. The children whose sleep was affected by breathing problems like snoring, mouth breathing or apnea were 40% to 100% more likely than normal breathers to develop behavioral problems resembling A.D.H.D.

Children at highest risk of developing A.D.H.D.-like behaviors had sleep-disordered breathing that persisted throughout the study but was most severe at age 2 1/2.

“Lack of sleep is an insult to a child’s developing body and mind that can have a huge impact,” said Karen Bonuck, the study’s lead author and a professor of family and social medicine at Albert Einstein College of Medicine in New York. “It’s incredible that we don’t screen for sleep problems the way we screen for vision and hearing problems.”

Source: New York Times Health

Transcend CPAP is Awarded Medtrade Spring Providers Choice Award

The Provider’s Choice Award was given to Transcend for best exemplifying optimal use of technology.

Source: MyTranscend.com

Somnetics International Inc., the Minneapolis-based maker of Transcend®, today announced that Transcend was awarded the “Providers Choice Award” at the close of the Medtrade Spring Conference held April 10-12 in Las Vegas, as voted on by the show attendees. The Provider’s Choice Award was given to Transcend for best exemplifying optimal use of technology.

Transcend is changing the way CPAP therapy is delivered as the world’s smallest, lightest, most portable and flexible continuous positive airway pressure (CPAP) and battery system. It is first in the industry to bring proven Waterless Humidification™ technology and lightweight, long-life battery systems to CPAP users, making Transcend the preferred choice for travel and home use.

Clarence Johnson, president, Somnetics said, “We are humbled and honored for the recognition we received with the Medtrade Provider’s Choice Award. This is the third prestigious award we’ve received in six months for product innovation and addressing the unmet needs of the CPAP market.”

Federal Motor Carrier Safety Administration (FMCSA) seeks comments on obstructive sleep apnea

Truckers have been hearing about recommendations the Medical Review Board is pressing on the Federal Motor Carrier Safety Administration concerning obstructive sleep apnea

The recommendations stem from a joint meeting of the Motor Carrier Safety Advisory Committee and the Medical Review Board. The recommendations include criteria for certification, conditional certification and disqualification of drivers with obstructive sleep apnea.

Some of the recommendations included in the notice for comment are:
Drivers with a BMI of 35 or greater to be certified for 60 days pending sleep study and treatment, followed by a 90-day certification if they’re compliant during first 60 days, followed by a one-year certification.

  • Clinicians may cite any combination of possible factors to require or recommend sleep labs. For example, drivers who are male and postmenopausal females with a BMI of 28 or greater, who have experienced a single-vehicle crash or have a 17-inch neck (male) or 15.5-inch neck (female) should be prepared to prove they don’t have sleep apnea. Other factors include being 42 or older, family history, and having a small jaw or airway.
  • Commercial drivers diagnosed with apnea may not be unconditionally certified medically to receive their CDL, and must instead use a CPAP at least four hours a day for 70 percent of days.
  • Any driver who reports excessive sleepiness during “the major wake period,” or experiences a crash associated with falling asleep, or has been found to be non-compliant in using a CPAP should be disqualified or immediately denied certification.

OOIDA Executive Vice President Todd Spencer, who serves on MCSAC, has spoken out against the recommendations on behalf of members.

“While there is plenty to indicate some commercial truck drivers have sleep apnea, we find virtually nothing to indicate that that is a factor in increased likelihood of crashes,” Spencer said following the most recent MCSAC meeting. “That’s what motor carrier safety needs to be all about. It needs to be focusing on crashes. But, nevertheless, if there is an opportunity to make some money and there are some people recognizing that opportunity – they’re going to seize the moment.

In addition to setting criteria for granting qualification to drivers with sleep apnea, and who should be tested, the recommendations also state that the preferred treatment is positive airway pressure (PAP).

“All individuals with OSA (obstructive sleep apnea) should be referred to a clinician with relevant experience,” the recommendation up for comment states.

It also goes on to state “PAP is the preferred OSA therapy.”

Given the wide variety of treatments available and the costs associated with the testing to diagnose sleep apnea, OOIDA is skeptical of the real motivation behind these recommendations.

The recommendations are not in a notice of proposed rulemaking. The agency is simply seeking comments on the recommendations. The recommendations can be ignored by FMCSA or implemented as guidance for medical examiners conducting DOT physicals.

The notice seeking comments will publish in the Federal Register on Friday, April 20. The agency will accept comments for 30 days

Visit: FMCSA offical website

Source: LandLineMag

Intermezzo: New Sleeping Pill for Middle of the Night Insomniacs

Purdue Pharma announced the pill, Intermezzo, was approved by the FDA. The drug is available at pharmacies nationwide. Intermezzo (generic zolpidem tartrate) uses the same active ingredient as Ambien, which was first approved for use in the U.S. in 1992. If you have used Ambien or even seen the commercials, you know it is only recommended for persons who have a full eight hours to devote to sleep. Intermezzo is shorter-acting, lasting only four hours. According to the FDA, Intermezzo should only be used if you have at least four hours of bedtime remaining.

Intermezzo was developed by Transcept Pharmaceuticals and is the Company’s first FDA approved product. Intermezzo is being marketed in the United States under the terms of a collaboration agreement between Transcept and Purdue Pharma L.P.

“Until today, patients with insomnia did not have an appropriate or FDA approved treatment option to take in the middle of the night because all other prescription sleep aids are approved to be used only at bedtime,” said Thomas Roth, Ph.D., Director of Sleep Medicine, Henry Ford Hospital. “Intermezzo represents an important treatment option for those insomnia patients who suffer difficulty falling back to sleep after a middle of the night awakening and seek a sleep aid that they can use only when they really need it to fall back to sleep in the middle of the night.”

Source: Transcept Pharmaceuticals