Upper Airway Resistance Syndrome Clinical Trial
Official title:
Efficacy of Oral Appliance for Upper Airway Resistance Syndrome: Randomized, Parallel, Placebo, Controlled Study
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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