Efficacy of oral appliance for Upper Airway Resistance Syndrome: randomized, paralel, placebo, controlled study

• Grant number: 13/22776-0
• Support Opportunities: Scholarships in Brazil - Master
• Effective date (Start): May 01, 2014
• Effective date (End): October 31, 2015
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Sonia Maria Guimaraes Pereira Togeiro Moura
• Grantee: Luciana Balester Mello de Godoy
• Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil

Abstract

Introduction: The Upper Airway Resistance Syndrome (UARS) is a sleep disorder characterized by airway resistance to breathing during sleep that leads to arousals and daytime sleepiness. There are few studies about UARS treatment and there is not any gold standard treatment for it yet. Objective: Primary: To evaluate the efficacy of oral appliance (OA) on improving fatigue in patients with UARS. Secondary: Evaluate the effects of treatment with OA in patients with UARS on sleepiness, mood, cognition, quality of life, metabolism and autonomic nervous system.Methods: Subjects with UARS (AHI d 5 events per hour of sleep and RDI > 5 events per hour or more than 30% of total sleep time with inspiratory flow limitation and with excessive daytime somnolence and/or fatigue) of both genders, with body mass index (BMI) lower than 35Kg/m2 and between 25 to 55 years of age will be included. Subjects will be randomly distributed in OA group and placebo (without treatment). At baseline evaluation, 3 months and 1 year after subjects will be submitted to sleep questionnaires, physical exam, ENT evaluation, baseline polysomnography, Epworth sleepiness scale, Multiple Sleep Latency Test, fatigue scale, neurocognitive testing, autonomic nervous system analysis (heart rate variability and 24-hour ambulatory blood pressure monitoring) and metabolic evaluation. Mean and standard deviation will be used for descriptive statistical analysis if normal distribution, and median and percentiles (25%, 75%) for variables not normally distributed. To compare treatment groups T test (parametric) and Mann Whitney (non parametric) will be used. For adjusted analysis, linear regression analysis will be used.