The American College of Physicians (ACP) has officially recommended weight loss and CPAP (in combination) as the first line of defense against obstructive sleep apnea. The information is not exactly news to sleep physicians, but industry advocates see it as another sign that sleep apnea treatment is firmly within the mainstream.

As a sign of the growing influence of oral appliances, the ACP also recommended a mandibular advancement device (MAD) as an alternative therapy for patients who prefer it, for those who do not comply with CPAP treatment.

“The evidence shows that a mandibular advancement device can effectively improve sleep study results and sleepiness,” said Molly Cooke, MD, FACP, president, ACP. “However, CPAP more effectively raised the minimum oxygen saturation compared to MAD.”

The new recommendations were published in the Annals of Internal Medicine, as well as in an ACP press release. The ACP reports that more than 18 million American adults have sleep apnea, which increases the risk of high blood pressure, heart attack, stroke, heart failure, and diabetes and increases the chance of driving or other accidents. Sleep apnea is also identified as a leading cause of excessive daytime sleepiness.

“Obesity is a risk factor for obstructive sleep apnea and the evidence indicates that intensive weight loss interventions help improve sleep study results and symptoms of OSA,” said Cooke, who is also a member of ACP’s Clinical Guidelines Committee. “Plus, losing extra weight is associated with many other health benefits.”

ACP’s guideline is titled Management of Obstructive Sleep Apnea in Adults and includes advice to help physicians practice high value care. “Physicians should stress the importance of compliance with treatments, especially CPAP,” said Cooke. “Doctors should weigh patient preferences and the likelihood of therapy adherence against costs before initiating CPAP treatment.”

ACP officials characterized the available evidence for treating OSA with surgery as “limited,” noting that it is associated with serious adverse events and “should not be used as initial treatment.”

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The trucking industry does not want the Federal Motor Carrier Safety Administration (FMCSA) to use “informal guidance” to address sleep apnea, and the House of Representatives agreed last week in dramatic fashion—passing HR 3095 by a vote of 405-0.

The bill, introduced earlier this month by Reps Larry Bucshon (R-Ind) and Daniel Lipinski (D-Ill), already has companion legislation in the Senate, thanks to Senators Roy Blunt (R-Mo) and Mark Warner (D-Va). The Senate version has reportedly been referred to the Commerce, Science and Transportation committee, where it awaits action.

“ATA [American Trucking Association] believes that testing alone for obstructive sleep apnea of truck drivers could cost the industry nearly $1 billion,” said ATA president and CEO Bill Graves in a statement two weeks ago. “If our industry is to be burdened with such a cost, then the FMCSA owes it to trucking to conduct a full and thorough rulemaking, including collection of scientific data and a cost-benefit analysis.”

The crux of the issue is “informal guidance” vs “rulemaking,” with rulemaking strongly favored by Congress and industry. “Trucking interests have registered deep concern about the use of a guidance, and have been pushing for the rulemaking approach,” wrote Oliver Patton in TruckingInfo. “They worry that the guidance will not give employers a clear enough statement of their legal responsibilities.”

Don Osterberg, senior vice president of Safety, Security and Driver Training for Schneider National, reportedly told Deputy Transportation Secretary John Porcari that a guidance has the effect of putting trucking companies in a tight legal spot. “It puts motor carriers in a situation where we can pick our lawsuit,” he said.

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Patients who received APAP prior to surgery had better postoperative results. Researchers at the University of Toronto came to the conclusion after examining 177 patients with an apnea-hypopnea index of more than 15 events per hour in a randomized controlled trial, the results of which were published in the October 2013 issue of Anesthesiology.

According to a press release from the American Society of Anesthesiologists (ASA), 87 participants received APAP for two to three nights before surgery, and five nights after surgery, while 90 participants received routine care. One hundred patients completed the study. Patients who received APAP did so for 2.4 to 4.6 hours per night.

“Postoperatively, patients who received APAP did better,” said ASA officials via press release. “Participants who received APAP had a median apnea-hypopnea index of three events per hour on the third postoperative night, while control patients had a median of 32 events per hour. Patients who received CPAP also had better oxygenation in the postoperative nights.”

Researchers hope the findings will encourage patients with OSA to use APAP, especially since daily compliance with the machine can be low. “Some patients are concerned that the machine will be uncomfortable,” noted Frances Chung, M.B.B.S., professor, Department of Anesthesia, University of Toronto, Ontario. “However, many adjust quickly and find its benefits very rewarding, especially in reducing depression and motor vehicle accidents due to troublesome sleep.”

Source: ASA

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In late August, the American Academy of Sleep Medicine (AASM) indefinitely suspended the requirement for accredited sleep centers to score hypopneas according to the 3% oxygen desaturation criterion.

The AASM continues to recommend scoring hypopneas using the 3% criterion. However, it is acceptable for accredited sleep centers to score hypopneas using an oxygen desaturation criterion of 4%. AASM-accredited sleep centers must document in the patient’s record whether hypopneas were scored using an oxygen desaturation criterion of 3% or 4%.

The new manual’s hypopnea scoring rule has significant changes, including the criterion that there “is a more than or equal to 3% oxygen desaturation from pre-event baseline or the event is associated with an arousal.” However, the coverage policies of a number of insurance payers, including Medicare, continue to require an oxygen desaturation of more than or equal to 4% when scoring hypopneas.

Payers can deny payment or deny patients their therapeutic equipment if documentation doesn’t comply with their requirements for diagnostic testing. Therefore, it is critical for sleep centers and DME suppliers to document compliance with payer requirements.

The AASM Board of Directors recognizes that it would be a significant burden for accredited sleep centers to be required to score sleep studies twice, using both the 3% and the 4% hypopnea desaturation criteria. Therefore, the AASM is suspending indefinitely the requirement for AASM-accredited sleep centers to score sleep studies using the 3% hypopnea criterion. This change is effective immediately.

“Any time a rule is changed, it causes some concern from an industry perspective because we have to modify our products to conform with a rule,” says Richard Bonato, PhD, president and CEO, Braebon Medical Corp, Ottawa, Canada. “We must follow strict government procedures that comply with FDA software development guidelines.

“The difficulty with the application of that particular rule is that the insurance payors were not on board,” continues Bonato. “So you have a clinical organization making one regulation, and another requirement from insurance payors, which presents a challenge to industry to balance the two.”

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Poor sleep equaled poor food choices in the latest Scandinavian study that concluded men who were sleep-deprived were significantly more likely to purchase food with greater calories than men with a good night’s rest.

Christian Benedict, PhD, of Sweden’s Uppsala University, found that sleep deprivation was associated with food purchases significantly higher in calories (9% or greater) and mass (18% or greater). The study titled “Acute sleep deprivation increases food purchasing in men”, as outlined in the Journal Obesity, showed patients who were sleep deprived made worse choices on the day following the poor night’s sleep.

Read full study here

According to a report, researchers gauged food purchasing habits of 14 normal-weight Swedish men participating in a two-condition, within-subject crossover study following a night of healthy sleep or sleep deprivation that was part of a larger sleep deprivation investigation.

Participants engaged in an experimental supermarket scenario where they would be given 300 Swedish kronor ($50 USD) to restock their empty pantry. They were also required to maximize their budget and to purchase an equal number of easily consumed foods and foods requiring preparation.

The authors concluded that this “suggests that increased food purchasing in the morning after nocturnal wakefulness may represent another mechanism through which a repeated or chronic lack of sleep promotes weight gain.”

They also noted that the study was limited by experimental design, a purely male study population, use of total sleep deprivation rather than partial sleep deprivation, and a small sample size.

Source: Obesity Research Journal

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Spanish researchers are again examining all facets of sleep apnea with a new study concluding that the severity of sleep apnea can independently predict the aggressiveness of malignant skin melanoma.

The research presented at the European Respiratory Society (ERS) Annual Congress adds new evidence to a number of studies that have found a link between cancer and the sleep disorder. According to a report on the ERS Web site, previous studies have looked at a link between sleep apnea and incidence rates from cancer.

Some experimental studies in mice have also shown that reduced oxygen levels in the blood, which is common in sleep apnea, enhanced tumor growth. The Spanish study if the first to look at the link between a specific type of cancer (skin melanoma) and sleep apnea.

Researchers studied 56 patients diagnosed with malignant skin melanomas. They measured the aggressiveness of the cancer along with the presence and severity of sleep apnea—60.7% of the patients had sleep apnea and 14.3% had severe sleep apnea.

The results found that the melanoma was more aggressive as the severity of sleep apnea increased. This was the case for all three measurements for sleep apnea severity. The severity measurements were also linked with other factors of aggressiveness, including the growth rate or the depth of invasion of the tumor.

“This is the first study in a human sample to show that sleep apnoea can worsen the outcomes of melanoma,” said lead author Francisco Campos-Rodriguez, MD, from the Hospital de Valme in Seville, Spain. “The findings are from a preliminary small sample, but if the results are confirmed in larger studies, this would have important clinical implications, particularly as sleep apnea can be easily treated and this could open up new therapeutic possibilities for people with both conditions. We have just begun a bigger prospective trial enrolling 450 patients with cutaneous melanoma to analyze this link further.”

Source: ERS Annual Congress

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