Study: Oral Device Therapy Reduces OSA Severity but Has No Effect on CVD Risk Factors

In patients with severe obstructive sleep apnea (OSA), mandibular advancement device (MAD) therapy—the main alternative to continuous positive airway pressure—reduced OSA severity and related symptoms, according to a new study. However, it had no effect on endothelial function and blood pressure, despite high treatment compliance.

“The impact of MAD therapy on endothelial function in OSA patients has not been evaluated in properly controlled and adequately powered trials,” the researchers said. “MAD studies are also frequently flawed by the absence of objectively measured compliance with the device.”
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Researchers randomly assigned 150 patients [86% males; mean (SD) age, 54 (10); median [IQR] apnea-hypopnea index, 41 [35-53]; mean Epworth sleepiness scale, 9.3 (4.2)] to effective MAD (n=75) or sham device (n=75). They assessed the primary outcome, change in reactive hyperemia index—a validated measurement of endothelial function—on an intention-to-treat basis. An embedded microsensor objectively measured treatment compliance.

On intention-to-treat analysis, they found effective MAD therapy not associated with improvement of endothelial function compared to the sham device. Office and ambulatory blood pressure outcomes did not differ between the 2 groups. Effective MAD therapy was associated with significant improvements in apnea-hypopnea index, micro-arousal index, and symptoms of snoring, fatigue and sleepiness. Mean objective compliance was 6.6 (1.4) hours/night with the effective MAD vs 5.6 (2.3) hours/night with the sham device.

“To the best of our knowledge, this is the first randomized trial of MAD therapy with objective compliance measurement,” the researchers said.

“In moderately sleepy patients with severe OSA, MAD therapy reduced sleep-disordered breathing and OSA-related symptoms with no effect on endothelial function and blood pressure despite high treatment compliance,” they concluded.

—Mike Bederka

Reference:

Gagnadoux F, Pépin JL, Vielle B, et al. Impact of mandibular advancement therapy on endothelial function in severe obstructive sleep apnea [published online Jan. 27, 2017]. Am J Respir Crit Care Med. http://www.thoracic.org/about/newsroom/press-releases/resources/oral-appliances-osa-cvd1.doc.