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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
79
The device is a flow generator used to open the airway during sleep.
The device increases the volume of the airway by mandibular traction.
Associação Fundo de Incentivo à Pesquisa
São Paulo, São Paulo, Brazil
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.
Performance Vigilance Test (PVT)
Time frame: 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
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
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.
Blood analysis for inflammatory.
Time frame: 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.
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
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
Beck Anxiety Inventory - BAI
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
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