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

Abstract

Purpose

This 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).

Methods

The 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.

Results

Fifty-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.

Conclusion

This 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.

Keywords:

• apnea
• hypopnea index
• obstructive sleep apnea
• oral pressure
• therapy
• treatment

Acknowledgments

Financial support for the conduct of this study was provided by ApniCure, Inc.

Disclosure

Dr Farid-Moayer was the principal investigator. He has no conflicts of interest to disclose. Dr Siegel is employed by ApniCure and the USA Department of Veterans Affairs and is Clinical Associate Professor of Anesthesia (Affiliated), Stanford University School of Medicine. Dr Black is a consultant to ApniCure and is Consulting Associate Professor, Stanford Center for Sleep Research and Medicine, Stanford University School of Medicine.