Efficacy of Oral Appliance for Upper Airway Resistance Syndrome
- Conditions
- Upper Airway Resistance Syndrome
- Interventions
- Other: PlaceboDevice: Brazilian Dental Appliance
- Registration Number
- NCT02636621
- Lead Sponsor
- Associação Fundo de Incentivo à Pesquisa
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Both genders
- Body mass index (BMI) ≤ 30Kg/m2
- Age from 25 to 50 years
- Clinical and polysomnographic diagnosis of Upper Airway Resistance Syndrome: Apnea/Hypopnea Index (AIH) ≤ 5 events/hour and Respiratory Disturbance Index (RDI) > 5 events/hour or > 30% of total sleep time with inspiratory flow limitation with excessive daytime somnolence or fatigue
- Unsatisfactory dental condition or severe temporomandibular disfunction;
- Nasal obstruction;
- Alcohol abuse and excessive consumption of psychotropic drugs;
- Clinical, neurological or psychiatric diseases not treated
- Less than 6 hours of sleep
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral device that does not change the volume of the airway Brazilian Dental Appliance Brazilian Dental Appliance The device increases the volume of the airway by mandibular traction.
- Primary Outcome Measures
Name Time Method Fatigue From the baseline evaluation to one year after the treatment with oral appliance Modified fatigue impact scale for Portuguese (MFIS- BR)
- Secondary Outcome Measures
Name Time Method Subjective excessive daytime sleepiness From the baseline evaluation to one year after the treatment with oral appliance Epworth sleepiness scale
Objective excessive daytime sleepiness From the baseline evaluation to one year after the treatment with oral appliance Multiple Sleep Latency Test
Mood - Anxiety From the baseline evaluation to one year after the treatment with oral appliance Beck inventories (BAI)
Mood - Depression From the baseline evaluation to one year after the treatment with oral appliance Beck inventories (BDI)
Sustained attention From the baseline evaluation to one year after the treatment with oral appliance Psychomotor Vigilance Test (PVT)
Cognition - Memory From the baseline evaluation to one year after the treatment with oral appliance Digit Symbol Substitution Test (DSST)
Cognition - Learning strategies From the baseline evaluation to one year after the treatment with oral appliance Rey Auditory-Verbal Learning Test (RAVLT)
Cognition - Immediate and late memories From the baseline evaluation to one year after the treatment with oral appliance Wechsler Memory Scale (WMS)
Cognition - Processing speed ability From the baseline evaluation to one year after the treatment with oral appliance Stroop Color Test
Cognition - Visual attention From the baseline evaluation to one year after the treatment with oral appliance Trail Making Test - TMT
Quality of sleep From the baseline evaluation to one year after the treatment with oral appliance Pittsburgh Sleep Quality Index (PSQI)
Quality of life From the baseline evaluation to one year after the treatment with oral appliance Functional Outcomes of Sleep Questionnaire (FOSQ)
Stress From the baseline evaluation to one year after the treatment with oral appliance Teste de Lipp
Metabolism From the baseline evaluation to one year after the treatment with oral appliance Blood analysis of metabolism
Autonomic nervous system analysis From the baseline evaluation to one year after the treatment with oral appliance Heart rate variability
Trial Locations
- Locations (1)
Associação Fundo de Incentivo à Pesquisa (AFIP)
🇧🇷São Paulo, Brazil