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

Abstract

Abstract:Objective: This feasibility study examined the initial-use safety and potential utility of a novel noninvasive oral pressure therapy (OPT) system designed to reduce airway obstruction during sleep. Methods: This was a single-center, proof-of-concept, single-treatment-night study in which subjects with obstructive sleep apnea (OSA) underwent a baseline polysomnography (PSG) study followed by PSG during use of an OPT system. The OPT system is composed of a bedside console, a polymer mouthpiece, and a flexible tube connecting the mouthpiece to the console. The console contains a pump that creates vacuum intended to pull the soft palate anteriorly and stabilize the tongue to reduce obstruction during sleep. Results: Fifty-four men and 17 women, aged 53.2 ± 11.5 years (mean ± SD) had a baseline apnea-hypopnea index (AHI) greater than 5 events per hour. OPT was generally well tolerated with no serious adverse events. OPT significantly decreased AHI from 34.4 ± 28.9 events per hour (mean ± SD) at baseline to 20.7 ± 23.3 (p < 0.001). Treatment produced an AHI less than 10 in 48% of the subjects. OPT significantly improved oxygen desaturation index (p < 0.001) and increased the percentage of the night with oxygen saturation of 90% or greater (p = 0.028). Stage-N1 sleep shifts, total sleep-stage shifts, awakenings and the percentage of sleep time spent in N1 sleep were significantly reduced with treatment. Conclusion: This proof-of-concept study suggests that OPT can produce clinically relevant relief of OSA in certain subjects who are readily identified by PSG during trial use of the noninvasive system. OPT shows promise as a new treatment option for OSA in appropriate patients.

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

“…The results of this study confirm the feasibility of OPT for treatment of OSA as reported previously in a study of OPT in a different cohort of 71 subjects with OSA using individually customized mouthpieces 10. The magnitude of AHI reduction in the present study was similar to the reduction from 34.4 ± 28.9 (mean ± SD) events per hour to 20.7 ± 23.3 events per hour found in the prior study.…”

“…The console creates vacuum in the oral cavity intended to pull the soft palate anteriorly to decrease airway obstruction during sleep. A previous study evaluated this approach using mouthpieces customized for each subject 10. A new version of the OPT mouthpiece has been developed and is now available in ten standard sizes to accommodate a range of oral dimensions in individuals without requiring a custom production process for each patient.…”

A Young Man Running Out of Treatment Options

“…OPT is generally well tolerated but initial side effects are commonly noted. 20 In the feasibility study, device-related side effects were reported by 32% of the subjects, but 92% of the side effects were mild. The most common side effect in the multicenter study 19 was oral tissue discomfort or irritation.…”

Novel Therapies in the Treatment of Obstructive Sleep Apnea

“…Oral pressure therapy: Whereas, use of CPAP opens up the airway in sleep induced collapse by means of positive pressure applied to the nose acting as a pneumatic splint, use of oral pressure therapy, by means of vacuum applied to the oral cavity, ensures that the tongue and soft palate do not fall back to decrease the upper airway lumen in sleep in patients with SDB, with or without anatomic defects 52 . The device has two components, a vacuum generator with a console which is placed outside and an intra-oral device, consisting of mouth pieces of various sizes.…”