A multicenter evaluation of oral pressure therapy for the treatment of obstructive sleep apnea

Abstract

Objective We aimed to evaluate the impact of a novel noninvasive oral pressure therapy (OPT) (Winx®, ApniCure) system on polysomnographic measures of sleep-disordered breathing, sleep architecture, and sleep stability in obstructive sleep apnea (OSA). Subjects and methods A 4-week, multicenter, prospective, open-label, randomized, crossover, first-night order of control vs treatment, single-arm trial was conducted in five American Academy of Sleep Medicine (AASM) – accredited sleep clinics and one research laboratory. Sixty-three subjects (analysis cohort) were studied from a screening cohort of 367 subjects. The analysis cohort was 69.8% men, ages 53.6 ± 8.9 years (mean ± SD), body mass index of 32.3 ± 4.5 kg/m2, with mild to severe OSA. At treatment initiation, subjects received random assignment to one night with and one without (control) treatment, and they were assessed again following 28 nights of treatment. Breathing and sleep architecture were assessed each night based on blind scoring by a single centralized scorer using AASM criteria. Results Average nightly usage across the take-home period was 6.0 ± 1.4 h. There were no severe or serious device-related adverse events (AEs). Median apnea–hypopnea index (AHI) was 27.5 events per hour on the control night, 13.4 events per hour on the first treatment night, and 14.8 events per hour after 28 days of treatment. A clinically significant response (treatment AHI ≤10/h and ≤50% of control values) was seen in 20 of the 63 subjects evaluated. Rapid eye movement percentage (REM%) was significantly increased, and N1%, stage shifts to N1 sleep, overall stage shifts, total awakenings, and arousals per hour were all significantly reduced at both treatment nights compared to controls. Mean Epworth sleepiness scale (ESS) was significantly reduced from 12.1 to 8.6 (Cohen d effect size, 0.68) in those untreated for two or more weeks prior to OPT study participation and remained unchanged in subjects who directly switched from continuous positive airway pressure (CPAP) therapy to OPT. Conclusion Clinically significant improvements in sleep quality and continuity, AHI, ODI, ESS, and overall clinical status were achieved in an easily identified subgroup. OPT was safe and well-tolerated and nightly usage was high.

A feasibility evaluation of oral pressure therapy for the treatment of obstructive sleep apnea

“…Nonsurgical treatments include continuous positive airway pressure (CPAP), oral appliances (i.e. mandibular advancement devices) [Clark et al 1996;Ferguson et al 2006], and nasal appliances [Colrain et al 2008]. Pharmacotherapy has had a very limited role as a primary treatment of OSA [Jayaraman et al 2008].…”

Positive airway pressure and electrical stimulation methods for obstructive sleep apnea treatment: a patent review (2005 – 2014)

“…The nasal expiratory positive airway pressure (EPAP) (Provent sleep therapy, Ventus Medical Inc., USA) is a unidirectional flow-resistant device aimed at regulating airflow through the nostrils (expiratory flow resistance without any inspiratory resistance). Different studies have been conducted to assess its effectiveness [55,56]. Significantly (p<0.001) reduction in AHI compared with initial PSG were reported in mild, moderate and severe OSAHS patients.…”

“…Colrain et al assessed the safety and effectiveness of the Winx device in a population composed of mild-to-severe OSAHS patients. Clinically significant improvement in AHI, sleep quality and continuity, and daytime sleepiness were reported [57]. Nevertheless, further work is needed to confirm the effectiveness of such devices as reliable alternative to conventional CPAP therapy.…”

Pilot Study of a Nasal Airway Stent for the Treatment on Obstructive Sleep Apnea

“…Alternative therapeutic devices that could replace CPAP for short or long periods are therefore required. Some previous studies have reported oral or nasopharyngeal appliances as non-surgical alternatives to CPAP for OSA patients who do not tolerate CPAP treatment [12][13][14][15][16][17][18]. Although the concept of nasopharyngeal tube insertion to maintain airflow through the upper airway during sleep was proposed in the 1980s and has been reviewed before [7,12,18], such devices are not currently in common use.…”