Comparison of objective adherence and effectiveness between two types of mandibular advancement devices for the treatment of obstructive sleep apnea: a crossover randomized study

• Grant number: 14/04571-5
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• Start date: October 01, 2014
• End date: September 30, 2016
• Field of knowledge: Health Sciences - Medicine
• Agreement: Coordination of Improvement of Higher Education Personnel (CAPES)
• Principal Investigator: Geraldo Lorenzi Filho
• Grantee: Nuria Castello Branco Martins
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

Introduction: Mandibular advancement devices (MADs) have become an established treatment for mild and moderate obstructive sleep apnea (OSA). The MADs published in the literature are based on the concept of mandibular advancement and upper airway stability. Design of MADs can affect comfort and adherence. However, only recently a proper technology was developed to measured MAD adherence objectively. In contrast with traditional MADs, which focus primarily on the level of mandibular advancement, we developed a new MAD that prioritizes the tongue physiological position with the mandibular advancement, called in this study Mandibular Advancement with Tongue Posture (MATP). In this study, we hypothesized that MATP will provide better compliance and therapy effectiveness in contrast with traditional MADs. Objective: The main goal of this study is compare the objective adherence and therapeutic effectiveness of two types of MADs in the treatment of OSA: traditional MAD widely used (SomnoDent), and MATP. Secondly, we will compare the comfort and patient satisfaction between the two types of MADs and compare the agreement among measures of subjective and objective adherence. Methods: The sample consists of 30 patients with mild or moderate OSA diagnosed by polysomnography (PSG). The study will be a crossover study and each patient will be treated with SomnoDent and MATP. Each MAD will be used for 3 months. A washout period of one month will be included between the two treatments. Before starting treatment with each MAD and at the end of the 1st, 2nd and 3rd month of treatment, patients will undergo evaluations that include: body mass index (BMI), neck and waist circumference, Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS). Patients will be monitored at the end of the 1st, 2nd and 3rd month of treatment through subjective evaluation of adherence, subjective evaluation of comfort and satisfaction and objective evaluation of compliance (Theramon®). PSG will be performed at the beginning and end of each treatment. (AU)