Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea

Study Overview
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Brief Summary
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Treatment response of mild obstructive sleep apnea (OSA) to continuous positive airway pressure (CPAP) therapy and oral appliance (OA) is still controversial. The aim of this study is to evaluate the effect of CPAP and OA treatment on: objective and subjective sleepiness, cognitive deficits, mood changes, quality of life, inflammatory profile and metabolic cardiovascular and hormonal alterations in mild OSA subjects. Subjects with mild OSA (apnea -hypopnea index of 5 or more events per hour of sleep and less than 15), both genders, body mass index lower than 35Kg/m2 and age between 18 to 65 years will be included. They also must have a minimum mandibular protrusion of 7mm. Subjects will be randomly distributed in three groups: group 1 with CPAP, group 2 with OA and group 3 will be the control. At baseline evaluation, six months, one year and three years, all subjects will be submitted to sleep questionnaires, physical examination, ear-nose and throat evaluation, baseline polysomnography (and with CPAP for groups 1), Epworth Sleepiness Scale, Karolinska Sleepiness Scale, Stanford Sleepiness Scale, Maintenance of Wakefulness Test, Chalder Fatigue Scale, Neurocognitive testing, Beck Inventories of anxiety and depression, Functional Outcomes of Sleep Questionnaire (FOSQ), WHOQOL-BREF quality of life questionnaire, Short Form-36 quality of life questionnaire, questionnaire for sexual dysfunction, blood analysis for inflammatory, metabolic and hormonal evaluation, assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction. Sleep hygiene care was offer to three groups. Analysis mean and standard deviation will be used for descriptive statistical and a general linear model will be applied for analysis within groups on different time.

Official Title
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Effectiveness of Continuous Positive Airway Pressure and Oral Appliances in Mild Obstructive Sleep Apnea: a Randomized, Parallel, Single Blind and Controlled Study

Conditions
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Mild Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Device: Continuous Positive Airway Pressure (CPAP)
* Device: Oral Appliance (BRD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both genders; body mass index lower than 35Kg/m2; age between 18 and 65 years old; polysomnographic and clinical diagnosis of mild apnea (apnea-hypopnea index of 5 or more events per hour of sleep and less than 15 and minimum mandibular protrusion of 7mm. Exclusion Criteria: Unsatisfactory dental conditions (active periodontal disease, extensive caries or insufficient teeth for appliance content); temporomandibular disorders (chronic joint or muscle disease); central apnea; claustrophobia and severe otorhinolaryngologic diseases (severe nasal septal deviation, marked hypertrophy of nasal turbinates, hypertrophy of tonsils and/or adenoids sharp); excessive use of alcohol and psychoactive drugs; clinical, neurological or psychiatric decompensated diseases; others sleep diseases and previous obstructive sleep apnea treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Continuous Positive Airway Pressure<br>Intervention group | Device: Continuous Positive Airway Pressure (CPAP)<br>* The device is a flow generator used to open the airway during sleep.<br>* Other names: Resmed (trademark). Autoset Vantage - fixed pressure.;|
| Active Comparator: Oral Appliance (BRD)<br>Intervention group | Device: Oral Appliance (BRD)<br>* The device increases the volume of the airway by mandibular traction.<br>* Other names: Brazilian Dental Appliance (BRD).;|
| No Intervention: Hygiene sleep care<br>Control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excessive Daytime Sleepiness |  | From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluations of fatigue. |  | From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral | 
| Evaluation of cognition. | Performance Vigilance Test (PVT) | From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. | 
| Evaluation of depression. | Beck Depression Inventory - BDI | From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. | 
| Evaluation of quality of life. |  | From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral | 
| Evaluation of inflammation. | Blood analysis for inflammatory. | From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral | 
| Evaluation of blood pressure. | Assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction. | From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral | 
| Evaluation of sexual dysfunction. |  | From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral | 
| Evaluation of anxiety | Beck Anxiety Inventory - BAI | From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral | 
| Evaluation of metabolism | Blood analysis for metabolism | From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral | 
| Evaluation of hormonal alterations. | Blood analysis for hormonal alterations. | From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. | 
| Evaluation of heart rate variability | Assessment of heart rate variability. | From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. | 
| Evaluation of endothelial disfunction. | Assessment of endothelial disfunction. | From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous positive airway pressure, Oral appliance, mild Obstructive Sleep Apnea Syndrome