Effects of Oropharyngeal Exercises on Snoring Intensity, Symptoms, Upper Airway Anatomy and Collapsability of Upper Airway Awake and Asleep in Patients With Primary Snoring and Mild to Moderate Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Snore
研究概览
简要总结
Randomized study of patients with primary snore, mild and moderate obstructive sleep apnea. Protocol include 40 patients randomized to oropharyngeal exercise or use of nasal dilator, breathing exercise and nasal lavage. The objectives are study the effects of therapy on oropharyngeal in a series of clinical and physiologic and anatomic variables, changes on snore and quality of sleep using Pharyngeal Critical Pressure, Magnetic Resonance, Negative expiratory pressure and snore analyses. Hypothesis that the therapy group (oropharyngeal exercises) will have more modifications compared to the control group.
详细描述
This is randomized study with multiple primary endpoints. In December 2012 the study also started collecting tongue strength and endurance (IOPI). Because not all patients are able to perform all evaluations, the publications will be divided and presented according to the completion of the required number of patients for each primary endpoint.
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
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects with primary snore, mild and moderate obstructive sleep apnea
排除标准
- •BMI > or = 40, craniofacial malformations, smokers, pregnant women, edentulous, total dental prostheses, use of hypnotic medications, stroke, neuromuscular dystrophy, coronary artery disease, chronic heart failure, chronic obstructive pulmonary disease, severe nasal obstructive disease, pharyngeal surgery,already made some kind of treatment for obstructive sleep apnea.
研究组 & 干预措施
1
Oropharyngeal exercises and oropharyngeal functions
干预措施: Oropharyngeal exercises (Behavioral)
2
Nasal dilator, respiratory exercise, nasal lavage
干预措施: Respiratory exercises, nasal dilator, nasal lavage (Behavioral)
结局指标
主要结局
Snore
时间窗: 3 months
Upper airway collapsability
时间窗: 3 months
Images from magnetic resonance
时间窗: 3 months
Negative expiratory pressure
时间窗: 3 months
次要结局
- Sleep related questionnaires(3 months)
研究者
Geraldo Lorenzi-Filho
Associated Professor of Pulmonary Division
University of Sao Paulo