We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Melatonin Treatment for Induced Transient Insomnia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00950885
First Posted: August 3, 2009
Last Update Posted: March 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Charles Andrew Czeisler, MD, PhD, Brigham and Women's Hospital
  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: Low Dose Melatonin Biological: Placebo Biological: High Dose Melatonin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Charles Andrew Czeisler, MD, PhD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Circadian phase [ Time Frame: Through the last 5 days of the study ]
  • Sleep efficiency [ Time Frame: During sleep throughout the 7 day study ]

Secondary Outcome Measures:
  • Neurobehavioral performance [ Time Frame: During wake throughout the 7 day study ]

Enrollment: 42
Study Start Date: September 2009
Study Completion Date: August 2013
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: Low Dose 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 melatonin
3.0 mg melatonin
Biological: High Dose 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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950885


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
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

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 ( U.S. NIH Grant/Contract )
First Submitted: July 22, 2009
First Posted: August 3, 2009
Last Update Posted: March 8, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Per the NIH Policy on Resource Sharing, we will make the datasets collected in this grant available following publication of the final study results. Such datasets will not contain identifying information per the regulations outlined in HIPAA, and written permission will be obtained from those requesting the datasets.

Keywords provided by Charles Andrew Czeisler, MD, PhD, Brigham and Women's Hospital:
sleep
alertness
performance
vigilance
circadian

Additional relevant MeSH terms:
Disease
Sleep Initiation and Maintenance Disorders
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants