Trial reportSleep medicine2015
Melatonin improves sleep in children with epilepsy: a randomized, double-blind, crossover study.
Trial report in Sleep medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05654415 (Efficacy of Melatony Versus Sleep Deprivation for EEG Recordings in Sleep), which is not on this map. Cited by 31 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy of Melatony Versus Sleep Deprivation for EEG Recordings in Sleep: a Randomized Crossed-over Study in Pediatric Patients With Epilepsy
Who cites it
31 citing papers in PubMed, 4 syntheses or guidelines pooled it, 83 citations in OpenAlex.
- Adverse Events Associated with Melatonin for the Treatment of Primary or Secondary Sleep Disorders: A Systematic Review.CNS drugs · 2019Pooled it
- Oral melatonin for non-respiratory sleep disturbance in children with neurodisabilities: systematic review and meta-analyses.Developmental medicine and child neurology · 2019Pooled it
- Pooled it
- Melatonin as add-on treatment for epilepsy.The Cochrane database of systematic reviews · 2016Pooled it
- Randomized Controlled Trial of Melatonin for Sleep Disturbance in Dravet Syndrome: The DREAMS Study.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2018Trial
- Sleep Management and Recovery After TBI in Kids (SMART-Kids): Pilot Trial Using Melatonin.Hospital pediatrics · 2026Article
- Anti-Inflammatory and Antioxidant Strategies in Epilepsy: From Molecular Mechanisms to Threshold Management.International journal of molecular sciences · 2026Review
- Obstructive sleep apnea and seizures: pathophysiological mechanisms and clinical implications: a narrative review.Sleep & breathing = Schlaf & Atmung · 2026Review
- Review
- The Role of Circadian Rhythm in Neurological Diseases: A Translational Perspective.Aging and disease · 2024Review
- The short-term and long-term adverse effects of melatonin treatment in children and adolescents: a systematic review and GRADE assessment.EClinicalMedicine · 2023Article
- Use of melatonin for children and adolescents with chronic insomnia attributable to disorders beyond indication: a systematic review, meta-analysis and clinical recommendation.EClinicalMedicine · 2023Article
- Article
- Effect of melatonin on sleep quality and EEG features in childhood epilepsy: a possible non-conventional treatment.Frontiers in neurology · 2023Article
- The role of melatonin in the treatment of type 2 diabetes mellitus and Alzheimer's disease.International journal of biological sciences · 2022Review
- Parents' Experiences of Weighted Blankets' Impact on Children with Attention-Deficit/Hyperactivity Disorder (ADHD) and Sleep Problems-A Qualitative Study.International journal of environmental research and public health · 2021Article
- Sleep Disruption Worsens Seizures: Neuroinflammation as a Potential Mechanistic Link.International journal of molecular sciences · 2021Review
- Hyperphosphorylation of Tau Due to the Interference of Protein Phosphatase Methylesterase-1 Overexpression by MiR-125b-5p in Melatonin Receptor Knockout Mice.International journal of molecular sciences · 2021Article
- Melatonin for an obese child withWorld journal of clinical cases · 2021Article
- Insomnia in neurological diseases.Neurological research and practice · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
Abstract
objectiveInsomnia, especially maintenance insomnia, is widely prevalent in epilepsy. Although melatonin is commonly used, limited data address its efficacy. We performed a randomized, double-blind, placebo-controlled, crossover study to identify the effects of melatonin on sleep and seizure control in children with epilepsy.
methodsEleven prepubertal, developmentally normal children aged 6-11 years with epilepsy were randomized by a software algorithm to receive placebo or a 9-mg sustained release (SR) melatonin formulation for four weeks, followed by a one-week washout and a four-week crossover condition. The pharmacy performed blinding; patients, parents, and study staff other than a statistician were blinded. The primary outcomes were sleep onset latency and wakefulness after sleep onset (WASO) measured on polysomnography. The secondary outcomes included seizure frequency, epileptiform spike density per hour of sleep on electroencephalogram (EEG), and reaction time (RT) measures on psychomotor vigilance task (PVT). Statistical tests appropriate for crossover designs were used for the analysis.
resultsData were analyzed from 10 subjects who completed the study. Melatonin decreased sleep latency (mean difference, MD, of 11.4 min and p = 0.02) and WASO (MD of 22 min and p = 0.04) as compared to placebo. No worsening of spike density or seizure frequency was seen. Additionally, slow-wave sleep duration and rapid eye movement (REM) latency were increased with melatonin and REM sleep duration was decreased. These changes were statistically significant. Worsening of headache was noted in one subject with migraine on melatonin.
conclusionSR melatonin resulted in statistically significant decreases in sleep latency and WASO. No clear effects on seizures were observed, but the study was too small to allow any conclusions to be drawn in this regard.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.