Efficacy of melatonin with behavioural sleep-wake scheduling for delayed sleep-wake phase disorder: A double-blind, randomised clinical trial
Tracey L Sletten, Michelle Magee, Jade M Murray, Christopher J Gordon, Nicole Lovato, David J Kennaway, Stella M Gwini, Delwyn J Bartlett, Steven W Lockley, Leon C Lace, Ronald R Grunstein, Shantha MW Rajaratnam
PLOS MEDICINE | PUBLIC LIBRARY SCIENCE | Published : 2018
BACKGROUND: Delayed Sleep-Wake Phase Disorder (DSWPD) is characterised by sleep initiation insomnia when attempting sleep at conventional times and difficulty waking at the required time for daytime commitments. Although there are published therapeutic guidelines for the administration of melatonin for DSWPD, to our knowledge, randomised controlled trials are lacking. This trial tested the efficacy of 0.5 mg melatonin, combined with behavioural sleep-wake scheduling, for improving sleep initiation in clinically diagnosed DSWPD patients with a delayed endogenous melatonin rhythm relative to patient-desired (or -required) bedtime (DBT). METHODS: This randomised, placebo-controlled, double-blin..View full abstract
Awarded by National Health and Medical Research Council (NHMRC)
Awarded by NHMRC
The study was funded by a project grant from the National Health and Medical Research Council (NHMRC; 1031513) to SMWR, SWL, RRG, LCL, DJK and research support from the NHMRC Australasian Sleep Trials Network. Financial support for recruitment advertising was provided by Philips Respironics. RRG is supported by a NHMRC Senior Principal Research Fellowship (1106974). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.