CompletedNot Applicable

Melatonin Treatment for Induced Transient Insomnia

United States42 participantsStarted 2009-09

Plain-language 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.

Who can participate

Age range

18 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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; Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Circadian phase

Timeframe: Through the last 5 days of the study

Sleep efficiency

Timeframe: During sleep throughout the 7 day study

Trial details

NCT IDNCT00950885

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-08

View on ClinicalTrials.gov More Delayed Sleep Phase Disorder trials