Inducing Slow Wave Sleep to Treat Obstructive Sleep Apnea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Apnea Hypopnea Index (AHI)
研究概览
简要总结
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Interestingly, the severity of OSA is profoundly reduced in deep sleep (called "slow wave sleep"), potentially via an increase in the stimulus required to arouse from sleep. Here the investigators test the idea that the medication called "tiagabine" improves slow wave sleep and reduces OSA severity. The investigators will also test whether tiagabine raises the arousal threshold (more negative esophageal pressure), and whether detailed OSA "phenotyping" characteristics can predict the improvement in OSA severity with this intervention.
详细描述
The current study tests the primary hypothesis that tiagabine improves sleep apnea severity in patients with moderate-to-severe sleep apnea (apnea hypopnea index measured in supine non-REM sleep; hypopneas defined by 3% desaturation or arousal). The investigators test three secondary hypotheses that tiagabine:
- increases the proportion of total sleep time in slow wave sleep
- raises the non-REM arousal threshold (more negative esophageal pressure) via (1).
- is preferentially effective in patients whose OSA phenotype predicts that an increase in the arousal threshold is sufficient to resolve OSA versus those without such favorable physiology. Favorable physiology is defined here as having a low ventilatory drive at which stable breathing is theoretically feasible ("stable Vdrive" is <100% above eupneic ventilatory drive) due to any combination of a "high" upper airway muscle response, "good" passive anatomy (high Vpassive), and "low" steady-state loop gain (see Owens RL et al SLEEP 2014; Wellman A et al J Appl Physiol 2011, 2013; Eckert DJ et al 2013 AJRCCM).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed OSA (moderate-to-severe; apnea hypopnea index >15 events/hr)
排除标准
- •History of seizures
研究组 & 干预措施
Tiagabine
Tiagabine PO 12 mg before sleep
干预措施: Tiagabine (Drug)
Placebo
Placebo PO before sleep
干预措施: Placebo (Drug)
结局指标
主要结局
Apnea Hypopnea Index (AHI)
时间窗: 1 night
Number of apneas + hypopneas per hour of sleep. Hypopnea criteria: reduction in 30% of baseline flow plus 3% desaturation or arousal.
次要结局
- Slow Wave Sleep (% Total Sleep Time)(1 night)
- Arousal Threshold (Esophageal Pressure Swing)(1 night)
研究者
David Andrew Wellman
Director, Sleep Disordered Breathing Laboratory
Brigham and Women's Hospital