Effects of Light Treatment During Sleep on Young Men

NCT ID: NCT00796939

Last Updated: 2015-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will determine if green light exposure during sleep is effective in reducing mild depression symptoms in young men.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The circadian rhythm is the human body's internal clock. It affects sleeping and wakefulness patterns. Some scientists theorize that a disruption of circadian rhythms, or other circadian abnormalities, can cause a depressed state. Light received through the eyes can alter the circadian rhythm, and sustained exposure to artificial bright light during the last half of usual sleep time can change the phase of the circadian rhythm. Several studies have found that exposure to bright white light in the morning hours is an effective treatment for depression, especially during the first week of depression treatment. Other studies have shown that green or blue light is preferable to yellow or red light in depression treatment. This study will expose young men to different types of light during the last part of their sleep cycle to determine whether the treatment is safe and tolerable and whether it reduces mood disturbance and depression. The study will also determine the light's effect on the production of luteinizing hormone (LH) and testosterone, hormones that may play a role in depression.

Participation in this study will last 15 days. At the beginning of the study, participants will be provided with study materials and instructed in their use. These materials will include a wrist actigraph, which is a sleep and wakefulness monitoring device similar to a wristwatch; a binder containing instructions, questionnaires, and forms; and a light mask. Participants will be randomly assigned to receive a light mask with either intense green or dim red light. Participants will wear the wrist actigraph throughout the study. For the first 3 days of the study, participants will sleep normally and fill out questionnaires and a sleep diary. The questionnaires will measure mood, sleepiness, sleep quality, treatment effects, and sleep time preference. The sleep diary will be a record of time spent sleeping, time it takes to fall asleep, number of times waking during the night, and similar measures. Starting on the third night, participants will wear the light mask when sleeping. Every day participants will fill out the questionnaires and sleep diary, and they will contact the study investigators to ensure compliance and to ask any questions. Participants will also provide saliva and urine samples once at the beginning and once at the end of the study. These samples will be used to test for testosterone and LH, respectively.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Green Light Mask

Group Type ACTIVE_COMPARATOR

Green light mask

Intervention Type DEVICE

Participants will receive approximately 10,000 lux from green light-emitting diodes.

Red light mask

Group Type PLACEBO_COMPARATOR

Red Light Mask

Intervention Type DEVICE

Participants will receive approximately 0.5 lux from white light-emitting diodes covered by a red gel.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Green light mask

Participants will receive approximately 10,000 lux from green light-emitting diodes.

Intervention Type DEVICE

Red Light Mask

Participants will receive approximately 0.5 lux from white light-emitting diodes covered by a red gel.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* Presence of clinical depression
* Presence of a sleep disorder
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of California, San Diego

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UCSD

La Jolla, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH068545

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MH68545

Identifier Type: -

Identifier Source: secondary_id

DATR A3-NSS

Identifier Type: -

Identifier Source: secondary_id

R01MH068545

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Green Light Effect on Sleep
NCT04828473 UNKNOWN NA
Light Sensitization Study
NCT01327040 COMPLETED NA
Shifting Sleep Timing in Teens
NCT05808179 RECRUITING NA
Pilot Sleep Extension and Mood
NCT06675799 COMPLETED NA