Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Apnea-hypopnea index
研究概览
简要总结
This study will conduct 3 intervention trials with 44 different participants in each trial, with 22 participants will undergo in-laboratory overnight polysomnograms (PSGs) at one night of medication intervention, and the other 22 at taking placebo (contained starch) 1 h before sleep. Three medication regimens will be tested: (1) atomoxetine 80mg combined with oxybutynin 5mg; (2) venlafaxine 37.5mg; and (3) oxybutynin 5mg combined with trazodone 100mg. Endotypic traits will be estimated using the Phenotyping Using Polysomnography method. The primary outcome is the change in apnea-hypopnea index, and secondary outcomes include endotypic traits and sleep parameters.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •apnea-hypopnea index ≥ 15 hr-¹
排除标准
- •the presence of pulmonary, cardiac, neurologic, or other active severe medical or psychiatric diseases
- •current use of continuous positive airway pressure therapy
- •use of drugs that might interact with the investigational medication or known to affect sleep during the trial or 1 month before the study
- •known allergy to the investigational medication
- •current smoking
- •heavy alcohol drinking (male > 14 drinks and women >7 drinks per week)
- •pregnant or lactating
- •periodic limb movement index > 15hr-1
- •the presence of sleep-related hypoventilation
研究组 & 干预措施
atomoxetine 80mg combined with oxybutynin 5mg
Participants will receive atomoxetine 80mg combined with oxybutynin 5mg once (1 h before polysomnographic study).
干预措施: Atomoxetine 80mg combined with oxybutynin 5mg (Drug)
atomoxetine 80mg combined with oxybutynin 5mg
Participants will receive atomoxetine 80mg combined with oxybutynin 5mg once (1 h before polysomnographic study).
干预措施: Placebo (Drug)
venlafaxine 37.5mg
Participants will receive venlafaxine 37.5mg once (1 h before polysomnographic study).
干预措施: Placebo (Drug)
oxybutynin 5mg combined with trazodone 100mg
Participants will receive oxybutynin 5mg combined with trazodone 100mg once (1 h before polysomnographic study).
干预措施: oxybutynin 5mg combined with trazodone 100mg (Drug)
oxybutynin 5mg combined with trazodone 100mg
Participants will receive oxybutynin 5mg combined with trazodone 100mg once (1 h before polysomnographic study).
干预措施: Placebo (Drug)
venlafaxine 37.5mg
Participants will receive venlafaxine 37.5mg once (1 h before polysomnographic study).
干预措施: Venlafaxine 37.5mg (Drug)
结局指标
主要结局
Apnea-hypopnea index
时间窗: Pre-intervention and after single night intervention
Change in apnea-hypopnea index.
Physiological parameter
时间窗: Baseline and one week
Change in apnea-hypopnea index.
次要结局
- Arousal threshold(Pre-intervention and after single night intervention)
- Upper airway collapsibility(Pre-intervention and after single night intervention)
- Loop gain(Pre-intervention and after single night intervention)
- Upper airway muscle compensation(Pre-intervention and after single night intervention)
- Endotypic traits(Baseline and one week)
研究者
Wan-Ju Cheng
Principal Investigator
China Medical University Hospital