Randomized Placebo-Controlled Crossover Trial of Zolpidem for Sleep in Children With Autism
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change from baseline in sleep architecture as measured by polysomnography (PSG), examples include sleep latency and non-rapid eye movement (NREM)
研究概览
简要总结
The purpose of this study is to examine the effect of zolpidem on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Zolpidem is a nonbenzodiazepine GABAa receptor agonist drug that acts as a hypnotic. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of zolpidem on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Zolpidem, then Placebo
Participants will first receive Zolpidem for a 4-week period. A 5 mg dose of Zolpidem will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.
Participants will then receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.
干预措施: Zolpidem (Drug)
Zolpidem, then Placebo
Participants will first receive Zolpidem for a 4-week period. A 5 mg dose of Zolpidem will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.
Participants will then receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.
干预措施: Placebo (Drug)
Placebo, then Zolpidem
Participants will first receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.
Participants will then receive Zolpidem for a 4-week period. A 5 mg dose of Zolpidem will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.
干预措施: Zolpidem (Drug)
Placebo, then Zolpidem
Participants will first receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.
Participants will then receive Zolpidem for a 4-week period. A 5 mg dose of Zolpidem will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in sleep architecture as measured by polysomnography (PSG), examples include sleep latency and non-rapid eye movement (NREM)
时间窗: Baseline, Week 4 and Week 8
次要结局
- Change from baseline in sleep efficiency as measured by actigraphy(Baseline, Week 4 and Week 8)
研究者
Antonio Hardan
Professor of Psychiatry and Behavioral Sciences
Stanford University