Obstructive Sleep Apnea Clinical Trial
Official title:
Optimal Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Obstructive Sleep Apnea Syndrome
Background: The oral appliances have been increasingly used in the treatment of primary
snoring and in patients with mild obstructive sleep apnea syndrome besides being treatment
options in adults with moderate to severe sleep apnea who did not accept or adapt to
continuous positive airway pressure (CPAP). It is not well established yet in the
literature, which patients with mild to moderate OSA will present a good response to
treatment with oral appliances.
Objective: To determine a value of CPAP pressure that correlates with a favorable response
to the use of oral appliance in patients with mild to moderate sleep apnea.
Patients and Methods: Two groups of 30 male patients (25-65 years, body mass index < 35
kg/m2) will be selected: the first group with an apnea-hypopnea index (AHI) between 5 and 15
events per hour of sleep and the second one with an AHI between 15 and 30 events per hour of
sleep. Each patient will undergo three polysomnographic recordings (baseline, CPAP
titration, after two months of treatment with oral appliance). Subjective (sleep disorders
questionnaire, the Epworth Sleepiness Scale, and sleep diaries) and objective
(polysomnography) parameters of sleep will be evaluated, besides the quality of life
(SF-36), mood (POMS), and anthropometric measurements (neck circumference and craniofacial
characteristic). Good response to treatment with the AIO will be considered as a 50%
reduction in the baseline AHI index or AHI after treatment less than 5 events per hour of
sleep.
n/a
Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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