Efficacy of Oral Appliance for Upper Airway Resistance Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Oral Appliance for Upper Airway Resistance Syndrome: Randomized, Parallel, Placebo, Controlled Study

Conditions
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Upper Airway Resistance Syndrome

Intervention / Treatment
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* Device: Brazilian Dental Appliance
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brazilian Dental Appliance<br>The device increases the volume of the airway by mandibular traction. | Device: Brazilian Dental Appliance<br>* 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.<br>* Other names: Mandibular advancement device;|
| Placebo Comparator: Placebo<br>Oral device that does not change the volume of the airway | Other: Placebo<br>* The placebo consists in a protective dental plate worn only during sleep that do not interfere in the size of the upper airway.<br>* Other names: Protective dental plate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Modified fatigue impact scale for Portuguese (MFIS- BR) | From the baseline evaluation to one year after the treatment with oral appliance | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective excessive daytime sleepiness | Epworth sleepiness scale | From the baseline evaluation to one year after the treatment with oral appliance | 
| Objective excessive daytime sleepiness | Multiple Sleep Latency Test | From the baseline evaluation to one year after the treatment with oral appliance | 
| Mood - Anxiety | Beck inventories (BAI) | From the baseline evaluation to one year after the treatment with oral appliance | 
| Mood - Depression | Beck inventories (BDI) | From the baseline evaluation to one year after the treatment with oral appliance | 
| Sustained attention | Psychomotor Vigilance Test (PVT) | From the baseline evaluation to one year after the treatment with oral appliance | 
| Cognition - Memory | Digit Symbol Substitution Test (DSST) | From the baseline evaluation to one year after the treatment with oral appliance | 
| Cognition - Learning strategies | Rey Auditory-Verbal Learning Test (RAVLT) | From the baseline evaluation to one year after the treatment with oral appliance | 
| Cognition - Immediate and late memories | Wechsler Memory Scale (WMS) | From the baseline evaluation to one year after the treatment with oral appliance | 
| Cognition - Processing speed ability | Stroop Color Test | From the baseline evaluation to one year after the treatment with oral appliance | 
| Cognition - Visual attention | Trail Making Test - TMT | From the baseline evaluation to one year after the treatment with oral appliance | 
| Quality of sleep | Pittsburgh Sleep Quality Index (PSQI) | From the baseline evaluation to one year after the treatment with oral appliance | 
| Quality of life | Functional Outcomes of Sleep Questionnaire (FOSQ) | From the baseline evaluation to one year after the treatment with oral appliance | 
| Stress | Teste de Lipp | From the baseline evaluation to one year after the treatment with oral appliance | 
| Metabolism | Blood analysis of metabolism | From the baseline evaluation to one year after the treatment with oral appliance | 
| Autonomic nervous system analysis | Heart rate variability | From the baseline evaluation to one year after the treatment with oral appliance | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, excessive daytime sleepiness, flow limitation