Elsevier

Sleep Medicine

Volume 14, Issue 9, September 2013, Pages 830-837
Sleep Medicine

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

https://doi.org/10.1016/j.sleep.2013.05.009Get rights and content

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.

Introduction

Obstructive sleep apnea (OSA) is a common medical condition [1], [2] which causes substantial morbidity and possibly mortality [3]. The process of repetitive airflow obstruction during sleep and the consequent need to arouse to breathe precipitates a reduction in the restorative effect of sleep, often leading to daytime sleepiness [4]. OSA patients also are at a significantly increased risk for negative impact on measures of attention and vigilance and on mood disturbance [5]. Moreover, chronic untreated OSA yields a significantly increased risk for cardiovascular diseases over a period of years, including hypertension, cardiac arrhythmias, atherosclerotic heart disease, myocardial infarction, stroke, death [6], and possibly type 2 diabetes mellitus [7].

No treatment exists for OSA that is both completely effective and fully tolerated by all patients; many partially efficacious or partially tolerated treatments currently are in use. Although nasal continuous positive airway pressure (CPAP) is the recommended therapy for reducing apneas and hypopneas [8], adherence to CPAP often is low [9], [10]. Given the seriousness of the risks associated with untreated or ineffectively treated OSA, it is important for physicians and patients to have a wide variety of treatment options to increase the likelihood of a successful option [11]. Our study describes a novel treatment modality, oral pressure therapy (OPT), which applies a vacuum to the mouth to stabilize upper airway tissue in patients with OSA.

Section snippets

Methods

The ATLAST study was a 4-week, multicenter, prospective, open-label, randomized, crossover, first-night order of control vs treatment, single-arm trial of the Winx Sleep Therapy System for the treatment of OSA. The objective of the study was to evaluate safety and efficacy of the Winx Sleep Therapy System. The study was approved by Western Institutional Review Board, Olympia, Washington, was conducted in compliance with US Food and Drug Administration Good Clinical Practice guidelines, and was

Subject disposition

Subject disposition is summarized in Fig. 2. The analysis cohort of 63 subjects comprised 33% without prior OSA treatment, 24% with prior CPAP experience who had abandoned CPAP therapy, and 43% who were active CPAP users when they elected to participate in our study.

AHI and ODI

Across the whole analysis cohort, the AHI reduction was statistically significant compared to controls at the first treatment night (Wilcoxon signed rank, P < .0001) and the treatment night following day 28 (Wilcoxon signed rank, P = 

Discussion

Data from the analysis cohort of 63 subjects indicated that OPT led to statistically significant improvements in AHI and ODI on the first treatment night and following 28 days of use. In the same cohort, there were statistically significant alterations in sleep architecture on treatment nights with reduced stage 1 shifts, reduced awakenings, a smaller arousal index, and reduced time spent in stage 1 sleep on both treatment nights relative to baseline; increased sleep efficiency, decreased wake

Conflicts of interest

Dr Black is a consultant to ApniCure and Dr Siegel is employed by ApniCure.

Acknowledgment

This work was supported by ApniCure Inc.

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      However, due to the complexity and diversity of OSAS, engaging patients in effective and “compatible” treatment is always a challenge. Over the past few years, oral pressure therapy (OPT) has emerged and has been proven to be an effective alternative treatment for continuous positive airway pressure (CPAP)-incompliant patients, with the treatment response rate varying largely between 25% and 79% [13–17], depending on the respiratory events rating rules and criteria used to define the “responders” to certain treatment. The latest OPT system, an intermittent negative airway pressure (iNAP) device [16,17], has a significantly lower oral tissue discomfort rate than the predicate device.

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