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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Positive Airway Pressure | Active Comparator | Intervention group |
|
| Oral Appliance (BRD) | Active Comparator | Intervention group |
|
| Hygiene sleep care | No Intervention | Control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure (CPAP) | Device | The device is a flow generator used to open the airway during sleep. |
|
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associação Fundo de Incentivo à Pesquisa | São Paulo | São Paulo | 04024-002 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32964829 | Derived | Guimaraes TM, Poyares D, Oliveira E Silva L, Luz G, Coelho G, Dal Fabbro C, Tufik S, Bittencourt L. The treatment of mild OSA with CPAP or mandibular advancement device and the effect on blood pressure and endothelial function after one year of treatment. J Clin Sleep Med. 2021 Feb 1;17(2):149-158. doi: 10.5664/jcsm.8822. | |
| 30077018 |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Oral Appliance (BRD) | Device | The device increases the volume of the airway by mandibular traction. |
|
|
| 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. |
| M Guimaraes T, Bittencourt L, P Luz G, O Silva L, Burke P, Coelho G, Milani A, Badke L, Togeiro S, Tufik S, Poyares D. Association between nondipping pattern and EndoPAT signal in patients with mild obstructive sleep apnea. Sleep Med. 2018 Nov;51:9-14. doi: 10.1016/j.sleep.2018.05.041. Epub 2018 Jun 27. |
| D012138 |
| Respiratory Therapy |