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| Sponsor: | Brigham and Women's Hospital |
|---|---|
| Information provided by: | Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00950885 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Delayed Sleep Phase Disorder Jet-lag Shift-work Disorder |
Dietary Supplement: Melatonin Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science |
| Official Title: | Efficacy of Melatonin Treatment in a Phase Advance Model of Transient Insomnia |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
placebo control group will receive 4 doses of identically-appearing capsules containing cellulose
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Dietary Supplement: Placebo
melatonin and placebo will be delivered as capsules on 5 successive days. All groups will receive placebo on days 1-3. Placebo group will continue to receive placebo on days 4 and 5, while low dose group will receive 0.3mg melatonin on days 4 and 5 and high dose group will receive 3.0mg melatonin on days 4 and 5.
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Experimental: Low dose melatonin
0.5 mg melatonin
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Dietary Supplement: Melatonin
melatonin and placebo will be delivered as capsules on 5 successive days. All groups will receive placebo on days 1-3. Placebo group will continue to receive placebo on days 4 and 5, while low dose group will receive 0.3mg melatonin on days 4 and 5 and high dose group will receive 3.0mg melatonin on days 4 and 5.
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Experimental: High dose
3.0 mg melatonin
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Dietary Supplement: Melatonin
melatonin and placebo will be delivered as capsules on 5 successive days. All groups will receive placebo on days 1-3. Placebo group will continue to receive placebo on days 4 and 5, while low dose group will receive 0.3mg melatonin on days 4 and 5 and high dose group will receive 3.0mg melatonin on days 4 and 5.
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Eligibility| Ages Eligible for Study: | 18 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sean W Cain, Ph.D. | 617-732-5174 | swcain@rics.bwh.harvard.edu |
| Contact: Jeanne F Duffy, MBA, Ph.D. | 617-732-7995 | jduffy@rics.bwh.harvard.edu |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Sean W Cain 617-732-5174 swcain@rics.bwh.harvard.edu | |
| Principal Investigator: | Charles A Czeisler, Ph.D., M.D. | Brigham and Women's Hospital |
More Information
| Responsible Party: | Charles A. Czeisler, Ph.D., M.D. Professor of Medicine, Brigham and Women's Hospital, Harvard Medical School |
| ClinicalTrials.gov Identifier: | NCT00950885 History of Changes |
| Other Study ID Numbers: | 1R01HL093279 |
| Study First Received: | July 22, 2009 |
| Last Updated: | June 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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sleep alertness performance vigilance circadian |
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Sleep Initiation and Maintenance Disorders Sleep Disorders, Circadian Rhythm Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Mental Disorders Chronobiology Disorders Occupational Diseases |
Melatonin Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |