Clinical Trial: Melatonin Treatment for Induced Transient Insomnia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy of Melatonin Treatment in a Phase Advance Model of Transient Insomnia
Brief Summary: Melatonin supplements have been reported to be an effective treatment for circadian rhythm sleep disorders, including shift work dyssomnia, jet-lag, delayed sleep phase syndrome, and sleep disruption suffered by many blind individuals. However, the mechanism(s) by which melatonin affects the timing of sleep are not well-understood. The purpose of this study is to determine if melatonin improves sleep and performance on a schedule simulating eastward travel. This study will provide information regarding the mechanism of action of melatonin that will be critical for the use of melatonin as a treatment for circadian rhythm sleep disorders.
Detailed Summary:
This study uses a randomized, double-blind, placebo-controlled, parallel groups design. The independent variable will be melatonin treatment group (0.3 mg melatonin, 3.0 mg melatonin, or placebo). Day of treatment will be an independent variable in analysis of sleep, cortisol, performance and alertness data. The primary outcome variables will be sleep efficiency and the peak of the plasma cortisol rhythm. Subjective and objective measures of alertness and performance during wake time will also be assessed as part of an exploratory analysis. Safety of short-term melatonin treatment will be assessed. The experimental protocol is divided into 5 segments, the ambulatory baseline segment, the laboratory adaptation segment, the initial constant posture (CP, to assess circadian phase), the melatonin/placebo intervention before advanced scheduled sleep, and second CP to assess final circadian phase.
The experimental protocol is divided into 5 segments, the ambulatory baseline segment, the laboratory adaptation segment, the initial constant posture (CP) for circadian phase assessment, the melatonin/placebo intervention, and a final post-treatment CP for assessment of circadian phase.
The Ambulatory Baseline consists of at least 21 days, outside the laboratory. During this segment, wrist activity and light levels will be recorded using an ambulatory recording device (Actiwatch-L) while the subject goes about his/her normal routine. During this segment, the subject will maintain a regular, self-selected sleep-wake/light-dark schedule (8h in bed, 16h awake), and a sleep diary. The subject will also call in to our time-stamped sleep-wake call-in telephone system just prior to each bedtime and immediately after each wake time.
The Laboratory Adaptation begins upon admission to the labora
Sponsor: Brigham and Women's Hospital
Current Primary Outcome:
- Circadian phase [ Time Frame: Through the last 5 days of the study ]
- Sleep efficiency [ Time Frame: During sleep throughout the 7 day study ]
Original Primary Outcome:
- Circadian phase [ Time Frame: Though the last 5 days of the study ]
- Sleep efficiency [ Time Frame: During sleep thoughout the 7 day study ]
Current Secondary Outcome: Neurobehavioral performance [ Time Frame: During wake throughout the 7 day study ]
Original Secondary Outcome: Same as current
Information By: Brigham and Women's Hospital
Dates:
Date Received: July 22, 2009
Date Started: September 2009
Date Completion:
Last Updated: March 7, 2017
Last Verified: March 2017
