NCT00630474已完成4 期
Does Nasal Decongestion Improve Obstructive Sleep Apnea ?
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- sleep related breathing disturbances sleep efficiency daytime sleepiness
研究概览
简要总结
Whether impaired nasal breathing contributes to sleep related breathing disturbances has not been known. Therefore, the purpose of the study is to compare the effect of xylometazoline, a drug that decongests the nasal mucosa when applied locally, with placebo in terms of sleep and nocturnal breathing and daytime performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obstructive sleep apnea syndrome (excessive sleepiness, apnea/hypopnea index >10/h)
- •Chronic nasal congestion (complaint of impaired nasal breathing that interfered with subjective sleep quality on at least 3 nights per week during at least the last 3 months)
排除标准
- •Nasal surgery within the last 6 months
- •Current treatment with nasal decongestants or topical steroids
- •Sleep disorders other than obstructive sleep apnea
- •Internal medical or psychiatric disorders that interfered with sleep
研究组 & 干预措施
1
Active Comparator
nasal application of xylometazoline
干预措施: xylometazoline (Drug)
2
Placebo Comparator
nasal application of placebo
干预措施: xylometazoline (Drug)
结局指标
主要结局
sleep related breathing disturbances sleep efficiency daytime sleepiness
时间窗: at end of one week treatment
次要结局
未报告次要终点
研究者
研究点 (2)
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