CompletedPhase 4ACTRN12611000734965

Efficacy of Melatonin for Sleep Disturbance Following Acquired Brain Injury


Sponsor

Monash University

Enrollment

80 participants

Start Date

Mar 9, 2012

Study Type

Interventional

Conditions

Summary

Sleep disturbance occurs in a significant proportion of the Acquired Brain Injury (ABI) population. Traumatic Brain Injury, a type of ABI, has been associated with reduced sleep quality, more night-time awakenings and longer sleep onset latency's. Recent research has shown that TBI patients have significantly lower endogenous concentrations of melatonin in the evening as compared to healthy controls. Melatonin is a naturally occurring hormone in the body which is intricately involved in the regulation of sleep and more importantly with the timing of sleep. Specifically, recent work has shown that this reduced concentration of melatonin was related to reduced rapid eye movement sleep and that these patients had more arousals during the evening. In light of recent work which provides evidence that a prolonged release melatonin formula is efficacious in treating age-related insomnia in individuals who also have decreased bodily concentrations of melatonin, it is hypothesized that melatonin will reduce the time taken to sleep and will improve sleep quality in ABI patients. The current study will implement a randomized, placebo-controlled crossover study with the aim of recruiting 80 participants. ABI patients who report sleep disturbance post injury will be eligible to participate. As this is a crossover design every participant will receive both the placebo and active melatonin treatments. If melatonin therapy is successful in reducing latency to sleep and improved sleep quality this could substantially improve the quality of life of individuals with ABI. As melatonin is a naturally occurring hormone relatively devoid of side-effects, its use to treat sleep disturbance could be implemented into clinical practice.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether melatonin supplements can improve sleep problems in adults aged 18 to 65 who have had a brain injury such as a traumatic brain injury or stroke. Participants must have significant sleep difficulties as measured by the Pittsburgh Sleep Quality Index. The trial compares melatonin to a placebo to see if it helps restore normal sleep patterns after brain injury.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Circadin melatonin 2mg prolonged release tablet is be taken orally after food and 1-2 hours prior to going to bed. Participants will be required to consume each of the respective treatments for a tota

Circadin melatonin 2mg prolonged release tablet is be taken orally after food and 1-2 hours prior to going to bed. Participants will be required to consume each of the respective treatments for a total of 8 weeks. Treatment intervention will commence at week 3 after the baseline run in period. As this a crossover study, the active melatonin treatment may be administered at either the first or second treatment intervention with each intervention 4 weeks in duration. The frist treatment intervention will commence at week 3 and end at week 6, with the second treatment intervention commencing at week 7 and finishing at week 10.


Locations(2)

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

Epworth Richmond - Richmond

VIC, Australia

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ACTRN12611000734965