Melatonin Treatment for Induced Transient Insomnia

NCT00950885 | Completed DMC

• 1 other identifier: 1R01HL093279
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delayed Sleep Phase Disorder; Jet-lag; Shift-work Disorder

Keywords

sleep; alertness; performance; vigilance; circadian

Outcome Measures

Primary Outcomes (2)

• Circadian phase

  Through the last 5 days of the study

• Sleep efficiency

  During sleep throughout the 7 day study

Secondary Outcomes (1)

• Neurobehavioral performance

  During wake throughout the 7 day study

Study Arms (3)

Placebo

PLACEBO COMPARATOR

placebo control group will receive 4 doses of identically-appearing capsules containing cellulose

Biological: Placebo

Low dose melatonin

EXPERIMENTAL

0.5 mg melatonin

Biological: Low Dose Melatonin

High dose melatonin

EXPERIMENTAL

3.0 mg melatonin

Biological: High Dose Melatonin

Interventions

Low Dose Melatonin BIOLOGICAL

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.

Low dose melatonin

Placebo BIOLOGICAL

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.

Placebo

High Dose Melatonin BIOLOGICAL

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.

High dose melatonin

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Jet Lag Syndrome

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Sleep Disorders, Circadian Rhythm; Dyssomnias; Sleep Wake Disorders; Travel-Related Illness; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Charles A Czeisler, Ph.D., M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Baldino Professor of Sleep Medicine

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: August 3, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 8, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)