Trial of Melatonin to Improve Sleep in Children With Epilepsy and Neurodevelopmental Disabilities

Last updated: December 1, 2014
Sponsor: The Hospital for Sick Children
Overall Status: Completed

Phase

3

Condition

Insomnia

Epilepsy

Mental Disability

Treatment

N/A

Clinical Study ID

NCT01161108
1000010842
  • Ages 5-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children aged 5-17 years

  • Children with epilepsy with at least 2 partial or generalized seizures per month overthe last 3 months prior to starting the trial

  • Children with neurodevelopmental disability, i.e. significant delay in developmentrequiring special educational setting or educational assistant

  • Anti-epileptic drugs (AED's) expected to remain unchanged for duration of trial (14weeks)

  • Not currently using melatonin or any other medication for sleep Subjects will beeligible if they have previous use of melatonin as long as there is a washout periodof at least 1 week. Similarly, children taking natural health products for sleep willbe 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 onsetlatency of greater than one hour, duration of sleep less than 8.5 hours per night witheither/or both these problems occurring at least 3 nights per week and that haveoccurred 3 months prior to trial, or night wakings of more than 2 per night for sametime period

Exclusion

Exclusion Criteria:

  • 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 orplacebo (e.g. lactose)

  • Lactose intolerance

  • Pregnant

  • 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)

Study Design

Total Participants: 13
Study Start date:
July 01, 2010
Estimated Completion Date:
June 30, 2012

Study Description

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.

Connect with a study center

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.