Efficiency of Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese Class III
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Quality of sleep
研究概览
简要总结
This study evaluates the effectiveness of intraoral appliance in the treatment of obstructive sleep Apnea Syndrome in class III obese in comparison to an adjustable silicone appliance. Both treatments will be test by all of the participants and they will make the polysomnography exam to have the outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥40 kg/m² and ≤ 49,9 kg/m²
- •Female and male patients (Both of gender patients) with ages between 20 to 65 years old
- •Obstructive Sleep Apnea (OSA) diagnosis by polysomnography
排除标准
- •sedative drugs users
- •Oxygen-dependent or decompensated lung disease
- •Decompensated congestive heart failure
- •Signs and symptoms of other sleeping disorders (narcolepsy, restless legs syndrome, insomnia)
- •craniofacial deformities carriers
- •previous OSAS Diagnosis and treatment
- •Active Oncological diseases in the last ten years
- •Patients with less than 8 teeth per arcade;
- •Patients with advanced periodontitis;
结局指标
主要结局
Quality of sleep
时间窗: 5 minutes
The Pittsburgh Sleep Quality Index is the instrument deployed to evaluate the subjective quality of sleep and the presence of possible disorders. The overall score is formed by the sum of seven components, which can be considered individually, being: 1 - Subjective sleep quality; 2 - sleep latency; 3 - Sleep duration; 4 - Usual efficiency; 5 - Sleep disorders; 6 - Use of sleep medications; 7 - Daytime sleepiness and disturbances during the day. The overall score is formed by the sum of seven components, which can be considered individually, being: 1 - Subjective sleep quality; 2 - sleep latency; 3 - Sleep duration; 4 - Usual efficiency; 5 - Sleep disorders; 6 - Use of sleep medications; 7 - Daytime sleepiness and disturbances during the day. The score is determined by the sum of the seven components, with each answer being given a score between 0 and 3 points. The maximum score of the instrument is 21. The scores\> 5 points indicate poor quality in the sleep pattern.
Quality of life
时间窗: 10 minutes
The Short-Form 36-Item Health Survey (SF-36) will be used to measure quality of life. This instrument will evaluate the physical health component (PHC) and the mental health component (MHC) through the following dimensions: functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health.
Daytime sleepiness
时间窗: 5 minutes
The Epworth sleepiness scale (ESS) wil measure the subjective daytime sleepiness, assesses the propensity to sleep under inappropriate circumstances. The ESS questionnaire consists of 8 questions about daytime sleepiness in various situations.
次要结局
- Apnea-hypopnea index (AHI)(8 hours)
研究者
Silvia de Carvalho Alvarenga
principal investigator
University of Sao Paulo