Efficacy of Melatonin for Sleep Disturbance Following Acquired Brain Injury

Phase 4

Completed

• Conditions: The primary health condition to be investigated is sleep disturbance in individuals who have sustained an acquired brain injury.; A secondary health condition is to investigate depression and anxiety.; Neurological - Other neurological disorders; Mental Health - Depression; Mental Health - Anxiety

• Registration Number: ACTRN12611000734965
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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 Criteria

-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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep onset latency[Mean sleep onset latency (minutes) will be measured continuously throughout the trial and over the 10 week period via Actigraphy. Sleep onset latency will be averaged over the baseline period and after each intervention period, respectively. <br>];Sleep quality: Sleep quality will be determined by global scores from the Pittsburgh sleep quality index (PSQI) questionnaire. The PSQI requires participants to subjectively rate their sleep quality in the previous month and will be used to determine treatment efficacy. [Sleep quality will be assessed pre and post baseline, and at the end of each treatment period. Consistent with other measures, sleep quality will be first assessed at baseline (week 0). The second takes place at the end of the baseline run-in period (week 2). The third at the end of treatment one (Week 6). The fourth at the end of treatment two (week 10).]