Efficacy of Oral Appliance for Upper Airway Resistance Syndrome
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Brazilian Dental Appliance The device increases the volume of the airway by mandibular traction. |
Device: Brazilian Dental Appliance
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.
Other Names:
|
| Placebo Comparator: Placebo Oral device that does not change the volume of the airway |
Other: Placebo
The placebo consists in a protective dental plate worn only during sleep that do not interfere in the size of the upper airway.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Both genders
-
Body mass index (BMI) ≤ 30Kg/m2
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Age from 25 to 50 years
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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:
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Unsatisfactory dental condition or severe temporomandibular disfunction;
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Nasal obstruction;
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Alcohol abuse and excessive consumption of psychotropic drugs;
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Clinical, neurological or psychiatric diseases not treated
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Less than 6 hours of sleep
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Associação Fundo de Incentivo à Pesquisa (AFIP) | São Paulo | Brazil | 04024-002 |
Sponsors and Collaborators
- Associação Fundo de Incentivo à Pesquisa
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SR94036