Inspiratory Muscle Training on Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Apnea hypopnea index
研究概览
简要总结
Introduction: Studies have shown the influence of exercise on sleep architecture and efficiency, although its protocols, procedures, effects and mechanisms of action have not been clearly explained and documented in the treatment of obstructive sleep apnea hypopnea syndrome (OSAHS), which is thought to be the main sleep disorder due to its high prevalence and clinical, social and cognitive consequences. Objective: To evaluate the effect of inspiratory muscle training (IMT) in OSAHS, by analyzing their influence on the quality of sleep, inspiratory muscle strength and polysomnography parameters. Patients and Methods: Controlled and randomized clinical trial involving 75 patients with OSAHS diagnosed by polysomnography. Measurements of maximal inspiratory pressure (MIP) will be performed. Pittsburgh scale Epworth, Sleepiness Scale, Short Form-36, and Berlin / Stanford questionnaires will be used for assessment of sleep quality, daytime sleepiness, health related quality of life quality of health, and the evaluation of snoring. Patients of the intervention group will undergo IMT with an initial load of 40% of MIP. The intervention will be performed daily for 12 weeks employing the exercise inspiratory device (POWERbreathe, HaB Ltd, UK). The main end point will be the effect of the training program on the index of apnea/hypopnea (IAH) assessed by polysomnography. Secondary end points will include effects of the training program on: the quality of sleep, inspiratory muscle strength, the health related QOL. Expected Results: if the hypothesis is confirmed, there will be improvements on the apnea / hypopnea index, on the quality of sleep and on the health related QOL.
详细描述
MATERIAL AND METHODS Study population Studied population will be derived from the Hospital Naval Marcilio Dias (HNMD), the sample consisting of active military personnel, reserve personnel and members of the naval family who seek the otorhinolaryngology service of the hospital.
Participants will be instructed about the objectives and methods of the present study and, in order to participate in the study, will be consulted to give their written consent for inclusion, according to the Informed Consent Term.
Study Design Study will be conducted through a prospective, controlled, randomized, and masked clinical trial for the participants and the investigator who will perform the data analysis.
Sample Characterization Reference Population It will consist of patients in medical care at the otorhinolaryngology clinic of Naval Hospital Marcílio Dias (HNMS), referred for polysomnography with a view to diagnosing OSAHS, obeying inclusion and exclusion criteria. All patients referred will be receiving the standard treatment for OSAHS, which consists of the nocturnal use of CPAP.
The stratified random probabilistic sample will consist of 2 (two) groups, control (sham) and intervention. Participants will be consecutively allocated in the intervention or control group by order of entry into the study and by level of severity of OSAHS to ensure fairness between groups regarding OSAHS severity.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age equal or greater than 18 years.
- •Diagnosis of obstructive sleep apnea and hypopnea syndrome (AHI> 5 events / hour).
排除标准
- •Acute or chronic pulmonary disease, uncontrolled arterial hypertension, heart failure, chronic renal failure and neurological disease.
- •Drug therapy that can influence muscle strength.
- •Psychiatric illness that may make adherence to the research protocol difficult.
- •Speech therapy or respiratory therapy in the last 3 months.
- •Orthodontic therapy with intraoral device.
- •BMI> 40 kg / m².
结局指标
主要结局
Apnea hypopnea index
时间窗: up to 04 weeks
measured by polysomnography
次要结局
- Daytime sleepiness(up to 04 weeks)
- Sleep quality: Pittsburgh sleep quality index(up to 04 weeks)
- Quality of life assessed by the The Medical Outcomes Study - Short-form 36 (SF-36)(up to 04 weeks)
- Inspiratory muscle strength(up to 04 weeks)