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Sleep Disorders
Volume 2013 (2013), Article ID 840723, 6 pages
http://dx.doi.org/10.1155/2013/840723
Clinical Study

The SomnuSeal Oral Mask Is Reasonably Tolerated by Otherwise CPAP Noncompliant Patients with OSA

1Sleep Laboratory, Assuta Medical Services and Wolfson Hospital, 69710 Holon, Israel
2Pulmonary Unit, Carmel Hospital and Clalit Health Care, 34362 Haifa, Israel
3Sleep Clinic, Clalit Health Care, 34362 Haifa, Israel
4Sleep Laboratory, Rambam Health Care Campus, P.O. Box 9602, 31096 Haifa, Israel
5Department of Pediatrics, Carmel Hospital and Faculty of Medicine, Technion-Israel Institute of Technology, 34362 Haifa, Israel

Received 5 June 2013; Revised 31 August 2013; Accepted 14 September 2013

Academic Editor: Liborio Parrino

Copyright © 2013 N. Katz et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Compliance with CPAP is the major limiting factor in treating patients with OSA. The novel SomnuSeal mask is an oral self-adaptable mask located between the teeth and the lips ensuring that there are no air leaks or skin abrasions. Fifty patients with , who failed previous CPAP trials, were asked to sleep with the mask for one month. In all patients, the mask was connected to an AutoPAP machine with a heated humidifier. Efficacy, convenience, and compliance (average usage for 4 or more hours per night) were monitored. Fifty patients (41 m and 9 f, mean age years, BMI  kg/m2, and AHI /h) participated. Eleven were classified as compliant (average mask usage of 26 nights, 4.7 hours per night), five were only partially compliant (average usage of 13 nights, 2.9 hours per night), and 34 could not comply with it. In all patients who slept with it, the efficacy (assessed by residual AHI derived from the CPAP device) was good with an AHI of less than 8/hour. Interestingly, the required optimal pressure decreased from an average of 9.3 cmH2O to 4.6 cmH2O. The SomnuSeal oral interface is effective and may result in converting noncompliant untreated patients with OSA into well-treated ones.