A Randomized Controlled Trial Pilot Project to Evaluate the Efficacy of Melatonin in Children With Insomnia, Intractable Epilepsy and Neurodevelopmental Disabilities
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in duration of nocturnal sleep time
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of oral melatonin in improving sleep continuity in children with epilepsy and neurodevelopmental delay who have chronic insomnia by comparing Fast Release Melatonin (FR MLT) to placebo and Timed Release Melatonin (TR MLT) with placebo in a randomized cross-over design trial.
详细描述
Sleep disturbance in children is a universal concern. The prevalence of sleep disorders may be as high as 80% in children with neurodevelopmental disabilities. The majority of the parental complaints are with difficulty getting children to settle to sleep at night and stay asleep (insomnia).
Two recent studies comparing children with epilepsy to matched controls or to sibling controls both concluded that children with epilepsy have more daytime sleepiness that may be due to underlying sleep disorders, and significantly greater sleep problems than their non-epileptic peers.
Endogenous melatonin is thought to synchronize the sleep-wake pattern with the light-dark cycle of the normal day. Exogenous melatonin has been found to be effective in reducing sleep onset latency, increasing sleep duration, and increasing sleep efficiency in a meta-analysis of subjects with sleep disorders. The melatonin in fast release preparations is released quickly and has a short half-life of less than 1 hour. It is most helpful in decreasing sleep onset latency (the time to fall asleep). The melatonin in timed release tablets is released in a slower more sustained way and, in a small study in children with severe neurodevelopmental disabilities, was more useful for sleep maintenance.
Fast release melatonin has been shown to be effective in a study of children with multiple disabilities and in one trial in children with epilepsy. Further rigorous evaluation of melatonin is needed as the validity of these studies is limited by their lack of blinding, small sample sizes, and subjective methods of sleep-wake outcome evaluations.
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
- Single (Investigator)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5-17 years
- •Children with epilepsy with at least 2 partial or generalized seizures per month over the last 3 months prior to starting the trial
- •Children with neurodevelopmental disability, i.e. significant delay in development requiring special educational setting or educational assistant
- •Anti-epileptic drugs (AED's) expected to remain unchanged for duration of trial (14 weeks)
- •Not currently using melatonin or any other medication for sleep Subjects will be eligible if they have previous use of melatonin as long as there is a washout period of at least 1 week. Similarly, children taking natural health products for sleep will be included as long as there is a 30 day washout period prior to study enrollment.
- •Chronic insomnia - reported by parent(s) to include one of the following: sleep onset latency of greater than one hour, duration of sleep less than 8.5 hours per night with either/or both these problems occurring at least 3 nights per week and that have occurred 3 months prior to trial, or night wakings of more than 2 per night for same time period
排除标准
- •Planned epilepsy surgery or change in AED's during treatment trial
- •Sleep disturbances that are treatable such as obstructive sleep apnea
- •Allergy or severe adverse effects to melatonin
- •Allergy or severe adverse effects to any of the ingredients of the study product or placebo (e.g. lactose)
- •Lactose intolerance
- •Breastfeeding
- •Known liver disease
- •Ketogenic diet
- •Other drugs being used for sedation
- •Immunosuppressive drugs
- •Known blood clotting abnormalities or who are on anticoagulant therapy (e.g. warfarin, blood thinners)
研究组 & 干预措施
Group A: Fast Release Melatonin
Subjects will be randomized to one of the two treatment arms and to the order of study medication v.s. placebo.
The subject will undergo the assigned treatment for 7 weeks (3 weeks of study drug, a one week wash-out and 3 weeks of placebo, or vice versa).
干预措施: Fast Release Melatonin (FR MLT) (Drug)
Group A: Fast Release Melatonin
Subjects will be randomized to one of the two treatment arms and to the order of study medication v.s. placebo.
The subject will undergo the assigned treatment for 7 weeks (3 weeks of study drug, a one week wash-out and 3 weeks of placebo, or vice versa).
干预措施: Fast Release Placebo (Drug)
Group B: Timed Release Melatonin
Subjects will be randomized to one of the two treatment arms and to the order of study medication v.s. placebo.
The subject will undergo the assigned treatment for 7 weeks (3 weeks of study drug, a one week wash-out and 3 weeks of placebo, or vice versa).
干预措施: Timed Release Melatonin (TR MLT) (Drug)
Group B: Timed Release Melatonin
Subjects will be randomized to one of the two treatment arms and to the order of study medication v.s. placebo.
The subject will undergo the assigned treatment for 7 weeks (3 weeks of study drug, a one week wash-out and 3 weeks of placebo, or vice versa).
干预措施: Timed Release Placebo (Drug)
结局指标
主要结局
Change in duration of nocturnal sleep time
时间窗: Baseline, Weeks 9 and 13
We will measure the sleep time between 7 pm and 9 am. The measures will be analyzed to determine the change from baseline and change between active treatment and placebo.
次要结局
- Sleep onset latency(Baseline, Weeks 9 and 13)
- Sleep efficiency(Baseline, Weeks 9 and 13)
研究者
Shelly Weiss
Staff neurologist
The Hospital for Sick Children