OSAS: Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Continuous Positive Airway Pressure Intervention group |
Device: Continuous Positive Airway Pressure (CPAP)
The device is a flow generator used to open the airway during sleep.
Other Names:
|
| Active Comparator: Oral Appliance (BRD) Intervention group |
Device: Oral Appliance (BRD)
The device increases the volume of the airway by mandibular traction.
Other Names:
|
| No Intervention: Hygiene sleep care Control group |
Outcome Measures
Primary Outcome Measures
- Excessive Daytime Sleepiness [From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.]
Secondary Outcome Measures
- Evaluations of fatigue. [From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral]
- Evaluation of cognition. [From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.]
Performance Vigilance Test (PVT)
- Evaluation of depression. [From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.]
Beck Depression Inventory - BDI
- 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. [From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral]
Blood analysis for inflammatory.
- Evaluation of blood pressure. [From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral]
Assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction.
- 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 [From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral]
Beck Anxiety Inventory - BAI
- Evaluation of metabolism [From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral]
Blood analysis for metabolism
- Evaluation of hormonal alterations. [From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.]
Blood analysis for hormonal alterations.
- Evaluation of heart rate variability [From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.]
Assessment of heart rate variability.
- Evaluation of endothelial disfunction. [From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.]
Assessment of endothelial disfunction.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Associação Fundo de Incentivo à Pesquisa | São Paulo | SP | 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.- 1300/11