Effects of Quetiapine on Sleep and Next Day Alertness in People With Obstructive Sleep Apnea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in OSA severity (Quetiapine night vs. placebo night)
研究概览
简要总结
Quetiapine is medication used to treat schizophrenia and bipolar disorder. Increasingly, low doses of quetiapine are prescribed "off-label" for insomnia. Quetiapine increases sleep duration with fewer interruptions, and people report feeling more rested. This accounts for why it is popular to prescribe for insomnia. Insomnia and obstructive sleep apnea (OSA) share many symptoms and differential diagnosis can be difficult. While quetiapine may improve sleep and breathing in certain people (i.e in light sleepers) an initial study indicated that quetiapine caused breathing disturbances in healthy individuals. Effects in OSA are unknown. In this placebo-controlled double blind study, participants with mild-moderate OSA will spend 2 nights in the sleep lab, one with quetiapine at a dose commonly prescribed for insomnia and one with placebo. The investigators will assess participants sleep by standard clinical sleep study, and morning alertness using questionnaires, reaction tests, and a driving simulator test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Ages: 18+ (Adult, Older Adult)
- •Gender: All
- •Moderate or more "difficulty staying asleep" score on the Insomnia Severity Index questionnaire
- •Obstructive Sleep Apnoea (OSA), Apnoea Hypopnea Index ≥ 5 events/hour
- •BMI between 18.5 and 40 kg/m2
排除标准
- •Concomitant medications that interact or are contraindicated with quetiapine
- •Concomitant medications known to influence breathing, sleep, arousal, or muscle physiology
- •Current pregnancy or breast-feeding
- •Current or recent other medical conditions likely to affect results or safety
研究组 & 干预措施
Quetiapine
Quetiapine 50mg in the form of one capsule, taken before bedtime. Dosage is taken on one instance for one night only.
干预措施: Quetiapine 50 MG (Drug)
Placebo
Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken on one instance for one night only.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in OSA severity (Quetiapine night vs. placebo night)
时间窗: Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.
OSA severity as measured by the AHI (apnoea hypopnea index measured as # events/h sleep) during overnight in-laboratory polysomnography.
次要结局
- Change in sleep architecture (Quetiapine night vs. placebo night)(Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.)
- Change in nadir overnight hypoxemia (Quetiapine night vs. placebo night)(Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.)
- Change in mean overnight hypoxemia (Quetiapine night vs. placebo night)(Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.)
- Change in sleep efficiency (Quetiapine night vs. placebo night)(Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.)
- Change in arousal index (Quetiapine night vs. placebo night)(Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.)
- Change in time below 90% blood arterial oxygen saturation (Quetiapine night vs. placebo night)(Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.)
- Change in respiratory control (Quetiapine night vs. placebo night)(Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.)
- Change in the respiratory arousal threshold (Quetiapine night vs. placebo night)(Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.)
- Change in airway collapsibility (Quetiapine night vs. placebo night)(Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.)
- Change in pharyngeal muscle response (Quetiapine night vs. placebo night)(Two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.)
- Baseline OSA endotypes (outcomes 8-11) and whether they are associated with changes in OSA severity (Quetiapine night vs. placebo night)(Baseline sleep study)
- Change in perceived sleepiness (Quetiapine night vs. placebo night)(Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.)
- Change in driving simulator performance (Quetiapine night vs. placebo night)(Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.)
- Change in psycho-motor vigilance (Quetiapine night vs. placebo night)(Next morning following two non-consecutive single night sleep studies (Quetiapine night vs. placebo night) up to one month apart.)
研究者
Professor Danny Eckert
Director, Adelaide Institute for Sleep Health
Flinders University