Effect of CPAP Therapy on Symptoms and Signs of Laryngopharyngeal Reflux Among Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Reflux symptom index (RSI) change
研究概览
简要总结
This study will investigate the changes in the reflux symptom index (RSI) and reflux finding score (RFS) among patients with obstructive sleep apnea after regular humidified CPAP therapy. Since these two diseases have strong associations then one may consider the possible benefits from therapy in between them.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have to stop proton pump inhibitors (PPI) therapy 1 month before enrollment in the study.
- •To be eligible as LPR patients in our study, patients must have presented a RSI score > 13 and a RFS score >
- •These thresholds were highly correlated with pathological pH monitoring (pH < 4)
排除标准
- •Noncompliance for CPAP Use: According to the standard Medicare criteria to define CPAP compliance, the patients who demonstrated CPAP use ≥ 4 h/ night for ≥ 70% of the nights are considered compliant.
- •Antireflux therapy during the period of the study.
结局指标
主要结局
Reflux symptom index (RSI) change
时间窗: Change from the baseline RSI at 3 months of regular humidified CPAP application
Assessment of the changes in the reflux symptom index (RSI) among patients with obstructive sleep apnea according to the determined time frame
Reflux finding score (RFS) change
时间窗: Change from the baseline RFS at 3 months of regular humidified CPAP application
Assessment of the changes in the reflux finding score (RFS) among patients with obstructive sleep apnea according to the determined time frame
次要结局
未报告次要终点
研究者
Aya Abouelela
Assistant Lecturer
Assiut University