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Title: | Randomized controlled trial of melatonin for sleep disturbance in dravet syndrome: The DREAMS study. | Authors: | Lightfoot P.A.;Scheffer I.E.;Myers K.A.;Davey M.J. ;Ching M.;Ellis C.;Grinton B.E.;Roten A. | Institution: | (Myers, Ellis, Grinton, Roten, Lightfoot, Scheffer) Epilepsy Research Centre, Department of Medicine, University of Melbourne, Austin Health, Heidelberg, VIC, Australia (Myers) Departments of Pediatrics and Neurology and Neurosurgery, Faculty of Medicine, McGill University, Montreal, QC, Canada (Davey) Melbourne Children's Sleep Centre, Monash Children's Hospital, Melbourne, VIC, Australia (Ching) Pharmacy Department, Austin Health, Heidelberg, VIC, Australia (Scheffer) Department of Paediatrics, University of Melbourne, Parkville, VIC, Australia (Scheffer) Department of Neurology, Royal Children's Hospital, Parkville, VIC, Australia (Scheffer) Florey Institute of Neuroscience and Mental Health, Heidelberg, VIC, Australia | Issue Date: | 29-Oct-2018 | Copyright year: | 2018 | Publisher: | American Academy of Sleep Medicine (2510 N. Frontage Road, Darien IL 60561, United States) | Place of publication: | United States | Publication information: | Journal of Clinical Sleep Medicine. 14 (10) (pp 1697-1704), 2018. Date of Publication: 15 Oct 2018. | Journal: | Journal of Clinical Sleep Medicine | Abstract: | 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. Method(s): 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. Result(s): 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). Conclusion(s): 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.Copyright © 2018 American Academy of Sleep Medicine. All right reserved. | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.5664/jcsm.7376 | Link to associated publication: | Click here for full text options | PubMed URL: | 30353809 [http://www.ncbi.nlm.nih.gov/pubmed/?term=30353809] | ISSN: | 1550-9389 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/37170 | Type: | Article | Subjects: | tonic clonic seizure/dt [Drug Therapy] wakefulness acetazolamide/dt [Drug Therapy] acetazolamide/pv [Special Situation for Pharmacovigilance] anticonvulsive agent/cr [Drug Concentration] anticonvulsive agent/pv [Special Situation for Pharmacovigilance] atomoxetine/dt [Drug Therapy] atomoxetine/pv [Special Situation for Pharmacovigilance] clobazam/dt [Drug Therapy] clobazam/pv [Special Situation for Pharmacovigilance] clonazepam/dt [Drug Therapy] clonazepam/pv [Special Situation for Pharmacovigilance] clonidine/dt [Drug Therapy] clonidine/pv [Special Situation for Pharmacovigilance] ethosuximide/dt [Drug Therapy] ethosuximide/pv [Special Situation for Pharmacovigilance] lamotrigine/dt [Drug Therapy] lamotrigine/pv [Special Situation for Pharmacovigilance] levetiracetam/dt [Drug Therapy] levetiracetam/pv [Special Situation for Pharmacovigilance] *melatonin/ct [Clinical Trial] *melatonin/cm [Drug Comparison] *melatonin/dt [Drug Therapy] *melatonin/pv [Special Situation for Pharmacovigilance] phenytoin/dt [Drug Therapy] phenytoin/pv [Special Situation for Pharmacovigilance] placebo stiripentol/dt [Drug Therapy] stiripentol/pv [Special Situation for Pharmacovigilance] topiramate/dt [Drug Therapy] valproic acid/dt [Drug Therapy] valproic acid/pv [Special Situation for Pharmacovigilance] zonisamide/dt [Drug Therapy] zonisamide/pv [Special Situation for Pharmacovigilance] topiramate/pv [Special Situation for Pharmacovigilance] actimetry adult anticonvulsant therapy article child clinical article controlled study crossover procedure double blind procedure drug blood level human ketogenic diet middle aged preschool child quality of life randomized controlled trial school child *severe myoclonic epilepsy in infancy *sleep disorder/dm [Disease Management] *sleep disorder/dt [Drug Therapy] preschool child quality of life randomized controlled trial school child *severe myoclonic epilepsy in infancy *sleep disorder / *disease management / *drug therapy tonic clonic seizure / drug therapy wakefulness Article anticonvulsant therapy actimetry adult clinical article controlled study crossover procedure double blind procedure drug blood level human ketogenic diet middle aged child |
Type of Clinical Study or Trial: | Randomised controlled trial |
Appears in Collections: | Articles |
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