Efficacy of Melatonin for Sleep Disturbance Following Acquired Brain Injury

Monash University0 个研究点目标入组 80 人开始时间: 2011年7月13日最近更新: 2020年1月13日

适应症

试验速览

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•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.

•-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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