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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Brazilian Dental Appliance is an oral appliance worn only during sleep that supports the jaw in a forward position to help maintain an open upper airway.
The placebo consists in a protective dental plate worn only during sleep that do not interfere in the size of the upper airway.
Associação Fundo de Incentivo à Pesquisa (AFIP)
São Paulo, São Paulo, Brazil
RECRUITINGFatigue
Modified fatigue impact scale for Portuguese (MFIS- BR)
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Subjective excessive daytime sleepiness
Epworth sleepiness scale
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Objective excessive daytime sleepiness
Multiple Sleep Latency Test
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Mood - Anxiety
Beck inventories (BAI)
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Mood - Depression
Beck inventories (BDI)
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Sustained attention
Psychomotor Vigilance Test (PVT)
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Memory
Digit Symbol Substitution Test (DSST)
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Learning strategies
Rey Auditory-Verbal Learning Test (RAVLT)
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Immediate and late memories
Wechsler Memory Scale (WMS)
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Processing speed ability
Stroop Color Test
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Visual attention
Trail Making Test - TMT
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Quality of sleep
Pittsburgh Sleep Quality Index (PSQI)
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Quality of life
Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Stress
Teste de Lipp
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Metabolism
Blood analysis of metabolism
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Autonomic nervous system analysis
Heart rate variability
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.