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

Inclusion Criteria8

  • Individuals with acquired brain injury (ABI), such as a traumatic brain injury (TBI) or stroke will be eligible to participate in the study;
  • Outpatients not currently hospitalized;
  • Able to understand and converse in English;
  • Adequate cognitive and physical ability to complete questionnaires;
  • Adequate visual acuity determined by the participants ability to read the questionnaires;
  • TBI Patients with mild to severe TBI who have sustained blunt head trauma with loss of consciousness, as determined by an initial Glasgow Coma Scale of 3-15 OR a period of post-traumatic amnesia;
  • Stroke patients with either Hemorrhagic or Ischemic infarctions.
  • ABI patients with reported sleep difficulties as determined by a Pittsburgh sleep quality index greater or equal to a score of 8.

Exclusion Criteria14

  • Pittsburgh sleep quality index less than 8;
  • History of other neurological problems prior to ABI;
  • Have traveled across more than 1 time zone in the preceding 3 months;
  • Have worked night shift in the preceding 3 months;
  • History of sleep disturbance prior to head trauma which required treatment;
  • History of Chronic fatigue requiring treatment prior to head trauma;
  • BMI greater than 30;
  • Requiring surgery during participation in the trial;
  • Current or previous history of illicit drug usage
  • Women who are breast feeding
  • Women currently pregnant or trying to conceive;
  • Currently taking psychotropic medication which includes benzodiazepines or hypnotics;
  • Currently taking Psycho stimulants;
  • Currently consuming complimentary medicines to treat sleep disturbance.

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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