Melatonin Treatment for Induced Transient Insomnia
Completed · Not applicable · Has a placebo group
Conditions studied: Delayed Sleep Phase Disorder, Jet-lag, Shift-work Disorder
In brief
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.
Key facts
- Study ID
- NCT00950885
- Run by
- Brigham and Women's Hospital
- People needed
- 42
- Starts
- 2009-09-01
- Expected to finish
- 2013-08-01
- Last updated by the study team
- 2017-03-08
Who can join
Age: 18 and older, up to 30. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Non-smoking for at least 6 months;
- Healthy (no medical, psychiatric or sleep disorders);
- No clinically significant deviations from normal in medical history, vital signs, physical examination, blood chemistry and hematology, and ECG;
- Women of childbearing potential must agree to use an acceptable method of birth control, and must have a negative serum pregnancy test;
- Body mass index of > 18 or < 30 kg/m2;
- No drugs or medication likely to affect sleep or alertness, as determined by the investigators;
You may not qualify if…
- History of alcohol or substance abuse;
- Positive result on drugs of abuse screening;
- Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, or any significant sleep complaint;
- Psychiatric disorder, including a history of depression or dysthymia (characterized by depressed mood on the majority of days for at least two years);
- Recent acute or chronic medical disorder, including but not limited to hepatic impairment and severe chronic obstructive pulmonary disease;
- History of intolerance or hypersensitivity to melatonin or melatonin agonists;
- Pregnancy or lactation;
- Shift work in the last 3 years;
- Transmeridian travel (2 or more time zones) in past 3 months;
- Any other scientific or medical reason, as determined by the PI, such as non-compliance with protocol or intolerance to inpatient study conditions.
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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