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Melatonin and Sleep in Patients With Epilepsy

ClinicalTrials.gov · COMPLETED, 2014

11 participants

Abstract

The prevalence of epilepsy is 1% in the USA. About 30% of epilepsy patients eventually become refractory to medical treatment. Co morbid conditions are becoming as important as seizure control as these affect overall wellbeing. Sleep related complaints are frequent in them including, frequent arousals, difficulty falling asleep and excessive daytime sleepiness. Polysomnography shows increased arousal index, sleep onset latency, and stage shifts and fragmented REM sleep. Poor sleep efficiency causes daytime fatigue, poor cognition and behavior and can worsen seizure control. Stabilizing sleep may improve seizure control. Melatonin is a naturally occurring hormone in the body involved in the regulation of circadian rhythm and exogenously given, has been shown to decrease sleep onset latency, arousals, and there-by increase sleep efficiency in healthy pediatric patients. Similar data does not exist in the patients with epilepsy. As sleep has important impact on epilepsy and overall functioning, it is important to study effect of melatonin in children with epilepsy.

We propose a randomized double blind placebo controlled trial with a cross-over design. Our hypothesis is that, for patients with epilepsy, administration of melatonin 30 minutes before bedtime for four weeks may:

* Improve the quality of sleep;

* Improve daytime functioning in terms of cognition, behavior and quality of life;

* Decrease epileptic potential. We will use polysomnography, electroencephalogram,…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 11 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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