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Melatonin Treatment for Induced Transient Insomnia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Charles Andrew Czeisler, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00950885
First received: July 22, 2009
Last updated: March 4, 2013
Last verified: March 2013
  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
Biological: Melatonin
Biological: 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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Circadian phase [ Time Frame: Though the last 5 days of the study ] [ Designated as safety issue: No ]
  • Sleep efficiency [ Time Frame: During sleep thoughout the 7 day study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurobehavioral performance [ Time Frame: During wake throughout the 7 day study ] [ Designated as safety issue: No ]

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
Biological: Placebo
Melatonin and placebo will be delivered as capsules on 4 successive days. All groups will receive placebo on days 1-3. Placebo group will continue to receive placebo on days 4, while low dose group will receive 0.5mg melatonin on day 4 and high dose group will receive 3.0mg melatonin on day 4.
Experimental: Low dose melatonin
0.5 mg melatonin
Biological: Melatonin
Melatonin and placebo will be delivered as capsules on 4 successive days. All groups will receive placebo on days 1-3. Placebo group will continue to receive placebo on days 4, while low dose group will receive 0.5mg melatonin on day 4 and high dose group will receive 3.0mg melatonin on day 4.
Experimental: High dose
3.0 mg melatonin
Biological: Melatonin
Melatonin and placebo will be delivered as capsules on 4 successive days. All groups will receive placebo on days 1-3. Placebo group will continue to receive placebo on days 4, while low dose group will receive 0.5mg melatonin on day 4 and high dose group will receive 3.0mg melatonin on day 4.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950885

Contacts
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

Locations
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   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Charles A Czeisler, Ph.D., M.D. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Charles Andrew Czeisler, MD, PhD, Baldino Professor of Sleep Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00950885     History of Changes
Other Study ID Numbers: 1R01HL093279
Study First Received: July 22, 2009
Last Updated: March 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
sleep
alertness
performance
vigilance
circadian

Additional relevant MeSH terms:
Disease
Pathologic Processes
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014