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

DOI: 10.1155/2013/840723

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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. 1. Introduction Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent hypoxemia, hypercapnia, and arousal from sleep and is associated with adverse neurocognitive and cardiovascular sequelae [1–6]. Application of continuous positive airway pressure (CPAP) leads to improvements in many of these adverse parameters [7–9], although residual sleep disordered breathing may still persist [10, 11]. The major limiting factor of CPAP treatment is compliance [12–14]. Some of the most important factors that have been reported as limiting compliance are skin abrasions or eruptions due to the pressure exerted by the mask, mask pressure on the ridge of the nose, claustrophobia, aerophagia, air leaks (eye irritation), dry mouth, dry nose, nasal stuffiness, epistaxis, sinusitis, facial pain or a noisy device, or pressure intolerance [15–21]. Other factors that have been identified as affecting compliance consist of disease severity, daytime sleepiness, motivation, age, socioeconomic status, education, race, marital status, spouse support, and copayment [12–31]. Even with the advanced and newer devices (such as the “C-Flex” CPAP device, BPAP, or automatic CPAP), data are not convincing for improved compliance [32–35]. Since CPAP treatment has a dramatic beneficial impact on patients [7–9, 23, 36–39], it is of great importance to seek interfaces that can improve


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