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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brazilian Dental Appliance | Active Comparator | The device increases the volume of the airway by mandibular traction. |
|
| Placebo | Placebo Comparator | Oral device that does not change the volume of the airway |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brazilian Dental Appliance | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LUCIANA GODOY, MD | Contact | 551121490155 | lu_bmg@yahoo.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associação Fundo de Incentivo à Pesquisa (AFIP) | Recruiting | São Paulo | São Paulo | 04024-002 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32686643 | Derived | de Godoy LBM, Sousa KMM, Palombini LO, Poyares D, Dal-Fabbro C, Guimaraes TM, Tufik S, Togeiro SM. Long term oral appliance therapy decreases stress symptoms in patients with upper airway resistance syndrome. J Clin Sleep Med. 2020 Nov 15;16(11):1857-1862. doi: 10.5664/jcsm.8698. | |
| 29045745 | Derived | Godoy LBM, Palombini L, Poyares D, Dal-Fabbro C, Guimaraes TM, Klichouvicz PC, Tufik S, Togeiro SM. Long-Term Oral Appliance Therapy Improves Daytime Function and Mood in Upper Airway Resistance Syndrome Patients. Sleep. 2017 Dec 1;40(12). doi: 10.1093/sleep/zsx175. |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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|
| Placebo | Other | The placebo consists in a protective dental plate worn only during sleep that do not interfere in the size of the upper airway. |
|
|
| 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 |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |