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A Pilot Randomised Controlled Trial of Sublingual Melatonin for Sleep Onset Insomnia in Children With Foetal Alcohol
Ned Chandler-Mather1, Doug Shelton2, Caroline Donovan1
1School of Applied Psychology, Griffith University, Queensland, Australia.
Insights
This pilot study found melatonin potentially effective for treating sleep onset insomnia in children with foetal alcohol spectrum disorder (FASD). While recruitment challenges exist, a randomized crossover design was feasible for future research.
Area of Science:
- Pediatric Sleep Medicine
- Neurodevelopmental Disorders
- Clinical Trial Methodology
Background:
- Children with foetal alcohol spectrum disorder (FASD) often experience significant sleep disturbances.
- Investigating interventions for sleep onset insomnia in this population is crucial.
Purpose of the Study:
- To assess the feasibility of a larger randomized controlled trial (RCT) for sleep issues in children with FASD.
- To evaluate the potential effectiveness of melatonin in treating sleep onset insomnia in this group.
Main Methods:
- A 10-week, double-blind, placebo-controlled, crossover study involving children diagnosed with or at risk of FASD.
- Sleep outcomes measured via actigraphy and the Child Sleep Habit Questionnaire (CSHQ).
- Executive functioning and carer stress were also assessed.
Main Results:
- Significant reductions in sleep onset latency (p=0.003) and bedtime resistance (p=0.004) were observed with melatonin compared to placebo.
- Data collection and retention were acceptable, but recruitment proved challenging.
- No serious adverse events were reported during the trial.
Conclusions:
- A randomized crossover design is feasible for children with or at risk of FASD, though multi-site recruitment is recommended.
- Melatonin shows potential efficacy in reducing sleep onset latency and bedtime behavioral issues in this population.
Aim:
Children with foetal alcohol spectrum disorder (FASD) present with significant sleep disturbance. This pilot trial aimed to examine the feasibility of conducting a larger randomised controlled trial (RCT) in this population and the potential effectiveness of melatonin to treat onset insomnia.
Methods:
Children with sleep onset delay and a designation of 'at risk' of FASD or a diagnosis of FASD were recruited to a 10-week, double-blind, placebo-controlled, crossover study of melatonin. Sleep outcomes were assessed using actigraphy. The child sleep habit questionnaire (CSHQ) and measures of executive functioning and carer stress were completed at baseline and after each treatment phase.
Results:
Fifty-nine children were assessed for eligibility, 18 were ineligible as they were taking sleep medication, and eight children entered the trial. Four received melatonin for 3 weeks followed by placebo for 3 weeks (arm A) and four received placebo followed by melatonin (arm B). Processes involving data collection and retention were acceptable. However, significant issues regarding recruitment were found. Quantitative measures were appropriate with significant reductions in sleep onset latency (n = 6) in the melatonin condition relative to the placebo condition (p = 0.003), and bedtime resistance (n = 8) according to the CSHQ (p = 0.004). No serious adverse events were reported.
Conclusions:
A randomised crossover design was feasible in this population; however, recruitment should be conducted across multiple sites. Melatonin is potentially effective at reducing sleep onset latency and behaviour difficulties at bedtime in children with or 'at risk' of FASD.
Trial Registration:
Australian New Zealand Clinical Trials Registry (12619001360101).
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