Effectiveness of Continuous Positive Airway Pressure and Oral Appliances in Mild Obstructive Sleep Apnea: a Randomized, Parallel, Single Blind and Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Excessive Daytime Sleepiness
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Excessive Daytime Sleepiness
时间窗: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
次要结局
- Evaluation of anxiety(From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral)
- Evaluation of endothelial disfunction.(From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.)
- Evaluations of fatigue.(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)
- Evaluation of sexual dysfunction.(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.)
- 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 blood pressure.(From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral)
- Evaluation of metabolism(From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral)
- Evaluation of depression.(From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.)
- Evaluation of 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(From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.)
研究者
Prof. Dr. Lia Azeredo-Bittencourt
Professor
Associação Fundo de Incentivo à Pesquisa