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Volume 14 No. 10
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Scientific Investigations

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

Kenneth A. Myers, MD, PhD1,2; Margot J. Davey, MBBS3; Michael Ching, PhD4; Colin Ellis, MD1; Bronwyn E. Grinton, BSc1; Annie Roten, BSc1; Paul A. Lightfoot, RN1; Ingrid E. Scheffer, MBBS, PhD1,5,6,7
1Epilepsy Research Centre, Department of Medicine, The University of Melbourne, Austin Health, Heidelberg, Victoria, Australia; 2Departments of Pediatrics and Neurology and Neurosurgery, Faculty of Medicine, McGill University, Montreal, Quebec, Canada; 3Melbourne Children's Sleep Centre, Monash Children's Hospital, Melbourne, Victoria, Australia; 4Pharmacy Department, Austin Health, Heidelberg, Victoria, Australia; 5Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; 6Department of Neurology, Royal Children's Hospital, Parkville, Victoria, Australia; 7The Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia

Study Objectives:

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), Sleep Disturbance Scale in Children and Quality of Life in Children with Epilepsy 55 questionnaires, caregiver reports of clinical change, seizure diary and serum antiepileptic drug levels. We also compared actigraphy data of patients with Dravet syndrome to an age-matched healthy control group.

Results:

A total of 13 patients completed the study. There was no difference in total sleep or WASO between melatonin and placebo. However, of the 11 patients for whom caregivers reported a clear clinical difference between treatments (blinded), 8 reported improvement on melatonin (P < .05). Interestingly, when compared to patients in the control group, patients with Dravet syndrome had significantly increased total sleep (P = .002).

Conclusions:

Melatonin did not increase total sleep; however, blinded caregiver reports indicate treatment with melatonin provided considerable clinical benefit for some patients with Dravet syndrome and sleep disturbance.

Clinical Trial Registration:

Registry: Australian Government Department of Health, Therapeutic Goods Administration under the Clinical Trials Notification Scheme (protocol number 2241)

Citation:

Myers KA, Davey MJ, Ching M, Ellis C, Grinton BE, Roten A, Lightfoot PA, Scheffer IE. Randomized controlled trial of melatonin for sleep disturbance in dravet syndrome: the DREAMS study. J Clin Sleep Med. 2018;14(10):1697–1704.




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