Randomized Controlled Trial of Melatonin for Sleep Disturbance in Dravet Syndrome: The DREAMS Study

Kenneth A Myers; Margot J Davey; Michael Ching; Cohn Ellis; Bronwyn E Grinton; Annie Roten; Paul A Lightfoot; Ingrid E Scheffer

Journal article

Randomized Controlled Trial of Melatonin for Sleep Disturbance in Dravet Syndrome: The DREAMS Study

Kenneth A Myers, Margot J Davey, Michael Ching, Cohn Ellis, Bronwyn E Grinton, Annie Roten, Paul A Lightfoot, Ingrid E Scheffer

JOURNAL OF CLINICAL SLEEP MEDICINE | AMER ACAD SLEEP MEDICINE | Published : 2018

DOI: 10.5664/jcsm.7376

Abstract

Dravet syndrome is a severe developmental and epileptic encephalopathy, in which 75% of patients have sleep disturbance. Melatonin is often used for sleep problems in childhood; however, there is no quality evidence supporting its use in Dravet syndrome. We hypothesized that melatonin would increase total sleep and quality of life for patients with Dravet syndrome.Methods: A double-blind crossover randomized placebo-controlled trial was conducted, comparing 6 mg regular-release melatonin to placebo for patients with Dravet syndrome and sleep disturbance. The primary outcome measure was total sleep measured by actigraphy, with secondary outcomes including wakefulness after sleep onset (WASO),..

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University of Melbourne Researchers

Bronwyn Grinton Author

Ingrid Scheffer Author

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Grants

Awarded by National Health and Medical Research Council (NHMRC)

Awarded by Taking Flight Award from Citizens United for Research in Epilepsy (CURE)

Awarded by NHMRC Practitioner Fellowship

Funding Acknowledgements

Work for this study was performed at Austin Health, University of Melbourne. All authors have seen and approved the manuscript. This study was primarily funded by philanthropic donations to Prof. Scheffer's Dravet syndrome research program, but also supported by funding from the National Health and Medical Research Council (NHMRC) Program Grants (628952, 1091593); Dr. Myers received salary support during the study from a Taking Flight Award from Citizens United for Research in Epilepsy (CURE; grant number 439534) and Prof. Scheffer holds a NHMRC Practitioner Fellowship (1104831). Dr. Myers received a travel grant from Zynerba, and has received research grant funding from Citizens United for Research in Epilepsy and Supporting Families with Koolen-de Vries Syndrome. Dr. Scheffer serves on the editorial boards of Neurology and Epileptic Disorders and has served on the editorial board of Annals of Neurology Epilepsy Currents; has received revenue from Medvet Science and Bionomics for patents; serves on the epilepsy advisory board for Nutricia; may accrue future revenue on a pending patent on therapeutic compound; has received speaker honoraria from Athena Diagnostics, UCB, GSK, Eisai, and Transgenomics; has received funding for travel from Athena Diagnostics, UCB, and GSK; and receives/has received research support from the National Health and Medical Research Council, Australian Research Council, NIH, Health Research Council of New Zealand, March of Dimes, Weizmann Institute, Citizens United for Research in Epilepsy, US Department of Defense, and Perpetual Charitable Trustees. The remaining authors report no conflicts of interest.