Skip to main content
OpenTrials
Completed

NCT Number: NCT00796939

Effects of Light Treatment During Sleep on Young Men

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UCSD

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Exclusion criteria

  • Presence of clinical depression
  • Presence of a sleep disorder

Treatment and study plan

Green light mask

Device

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

Red Light Mask

Device

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

Primary outcomes

  1. Safety, measured through the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire

    Time frame: Measured on Days 3 and 15

  2. Tolerability, measured through compliance reports

    Time frame: Measured daily for the length of the study

  3. Mood disturbance, measured on the Quick Inventory of Depressive Symptomology-Self Report (QIDS-SR)

    Time frame: Measured on Days 3 and 15

Secondary outcomes

  1. Sleep diary

    Time frame: Measured daily for the duration of the study

  2. Mood visual analog scale

    Time frame: Measured daily for the duration of the study

  3. Luteinizing hormone, measured through urinalysis

    Time frame: Measured on Days 3 and 13

  4. Testosterone, measured through saliva analysis

    Time frame: Measured on Days 3 and 13

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Randomized, Placebo-Controlled Trial of Short Wavelength Light Administered Just Prior to Waking in Young Men

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Nov 24, 2008
Registry last updated
Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.