Oral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility

Abstract

PurposeThis feasibility study examined the initial-use safety and effectiveness of a new noninvasive oral pressure therapy (OPT) system developed to treat obstructive sleep apnea (OSA).MethodsThe OPT system consists of a console that connects with flexible tubing to a premanufactured polymer mouthpiece. Through the mouthpiece, a pump in the console creates oral vacuum intended to move the soft palate anteriorly to decrease obstruction of the airway during sleep. The mouthpiece was produced in ten different sizes to accommodate a range of oral dimensions. Subjects with OSA in this single-center, single-night study underwent a polysomnography (PSG) study at baseline, followed by PSG during use of OPT.ResultsFifty-six men and 20 women, aged 50.8 ± 12.0 years (mean ± standard deviation [SD]), had OSA with apnea–hypopnea indices (AHI) greater than five events per hour at baseline. Body weight averaged 98.0 ± 18.2 kg (mean ± SD), body mass index ranged from 22.6 kg/m2 to 57.9 kg/m2 and averaged 32.5 ± 5.8 kg/m2 (mean ± SD). OPT was generally well tolerated without any serious adverse events. Baseline AHI was 38.7 ± 27.5 events/hour (mean ± SD) and was reduced with treatment to 24.6 ± 25.7 events/hour (P < 0.001, Cohen’s d 0.53). Treatment produced AHI less than or equal to ten events/hour in 38% of the subjects. Oxygen desaturation index was 30.1 ± 23.7 events/hour at baseline versus 15.8 ± 19.1 events/hour with treatment (P < 0.001, Cohen’s d 0.66). The minimum oxygen saturation increased with treatment from 77.9 ± 8.3 to 82.2 ± 7.9 (P < 0.001, Cohen’s d 0.53). Stage-N1 sleep shifts, total sleep-stage shifts, and awakenings were significantly reduced with treatment.ConclusionThis single-center, single-night feasibility study demonstrates that OPT can improve OSA in certain subjects identifiable by PSG during systematic usage. In appropriately responsive patients, OPT shows potential as a clinically useful new alternative for treatment of OSA without the need for custom manufacture of an oral device component.

Medical management of obstructive sleep apnea: a review article

“…Through the mouthpiece, a pump in console creates oral vacuum in the oral cavity intended to move the soft palate anteriorly to decrease obstruction of the airway during sleep. 66 Farid-Moayer et al demonstrated in their study that in appropriately responsive patients, OPT can improve OSA without need for custom manufacture of an oral device. 66…”

“…66 Farid-Moayer et al demonstrated in their study that in appropriately responsive patients, OPT can improve OSA without need for custom manufacture of an oral device. 66…”

Improvements in current treatments and emerging therapies for adult obstructive sleep apnea

“…As an alternative to applying positive pressure to maintain the patency of the upper airway, this device generates negative oral pressure by drawing the tongue and soft palate in more anterior positions via a mouthpiece connected to a suction mechanism. An initial single-center feasibility study evaluating 76 subjects with mild, moderate, or severe OSA treated with negative oral pressure therapy demonstrated improvements in OSA severity and oxygen desaturation, and 38% of the patients achieved an AHI of not more than 10 events per hour [ 40 ]. Based on these initial data, a recent short-term prospective multicenter randomized controlled trial evaluated 63 middle-aged, predominantly obese subjects across the spectrum of OSA severity [ 41 ].…”