Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea (OSAS)
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ClinicalTrials.gov Identifier: NCT01461486 |
Recruitment Status :
Completed
First Posted : October 28, 2011
Last Update Posted : November 13, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mild Obstructive Sleep Apnea Syndrome | Device: Continuous Positive Airway Pressure (CPAP) Device: Oral Appliance (BRD) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 79 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effectiveness of Continuous Positive Airway Pressure and Oral Appliances in Mild Obstructive Sleep Apnea: a Randomized, Parallel, Single Blind and Controlled Study |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | November 2019 |
Actual Study Completion Date : | November 2019 |

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 Name: Resmed (trademark). Autoset Vantage - fixed pressure. |
Active Comparator: Oral Appliance (BRD)
Intervention group
|
Device: Oral Appliance (BRD)
The device increases the volume of the airway by mandibular traction.
Other Name: Brazilian Dental Appliance (BRD). |
No Intervention: Hygiene sleep care
Control group
|
- Excessive Daytime Sleepiness [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. ]
- Evaluations of fatigue. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ]
- Evaluation of cognition. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ]
- Evaluation of inflammation. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral ]
- Evaluation of anxiety [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral. ]Assessment of endothelial disfunction.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461486
Brazil | |
Associação Fundo de Incentivo à Pesquisa | |
São Paulo, SP, Brazil, 04024-002 |
Responsible Party: | Prof. Dr. Lia Azeredo-Bittencourt, Professor, Associação Fundo de Incentivo à Pesquisa |
ClinicalTrials.gov Identifier: | NCT01461486 |
Other Study ID Numbers: |
1300/11 |
First Posted: | October 28, 2011 Key Record Dates |
Last Update Posted: | November 13, 2019 |
Last Verified: | November 2019 |
Continuous positive airway pressure Oral appliance mild Obstructive Sleep Apnea Syndrome |
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |