View clinical trials related to Upper Airway Resistance Syndrome.
Filter by:The clinical hypothesis of this study is that a currently marketed mouthguard may also be able to reduce the symptoms of sleep-disordered breathing in children.
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 on improving fatigue in patients with UARS. Secondary: Evaluate the effects of treatment with oral appliance (OA) in patients with UARS on sleepiness, mood, cognition, quality of life, metabolism and autonomic nervous system. Methods: Subjects with UARS (Apnea/Hypopnea Index - AHI - ≤ 5 events per hour of sleep and Respiratory Disturbance Index - 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 30Kg/m2 and between 25 to 50 years of age will be included. Subjects will be randomly distributed in OA group and placebo (without treatment). At baseline evaluation, 6 months and 1 year after subjects will be submitted to sleep questionnaires, physical exam, otolaryngological evaluation, baseline polysomnography, Epworth sleepiness scale, Multiple Sleep Latency Test, fatigue scale, neurocognitive testing, autonomic nervous system analysis (heart rate variability) 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.
This study is intended to compare intrathoracic pressure and respiratory effort data obtained by forehead venous pressure and respiratory movement (FVP/RM) with data obtained by the current gold standard, esophageal manometry. If this feasibility study validates the ability of FVP/RM data to quantitatively measure respiratory effort non-invasively, further studies will be performed to validate the utility of the ARES device in diagnosis of the UARS.