Effects of Light Treatment During Sleep on Young Men

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00796939
First received: November 21, 2008
Last updated: December 3, 2008
Last verified: December 2008
  Purpose

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


Condition Intervention
Depression
Device: Green light mask
Device: Red Light Mask

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled Trial of Short Wavelength Light Administered Just Prior to Waking in Young Men

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Safety, measured through the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire [ Time Frame: Measured on Days 3 and 15 ] [ Designated as safety issue: No ]
  • Tolerability, measured through compliance reports [ Time Frame: Measured daily for the length of the study ] [ Designated as safety issue: No ]
  • Mood disturbance, measured on the Quick Inventory of Depressive Symptomology-Self Report (QIDS-SR) [ Time Frame: Measured on Days 3 and 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep diary [ Time Frame: Measured daily for the duration of the study ] [ Designated as safety issue: No ]
  • Mood visual analog scale [ Time Frame: Measured daily for the duration of the study ] [ Designated as safety issue: No ]
  • Luteinizing hormone, measured through urinalysis [ Time Frame: Measured on Days 3 and 13 ] [ Designated as safety issue: No ]
  • Testosterone, measured through saliva analysis [ Time Frame: Measured on Days 3 and 13 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Green Light Mask Device: Green light mask
Participants will receive approximately 10,000 lux from green light-emitting diodes.
Placebo Comparator: Red light mask Device: Red Light Mask
Participants will receive approximately 0.5 lux from white light-emitting diodes covered by a red gel.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Exclusion Criteria:

  • Presence of clinical depression
  • Presence of a sleep disorder
  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: NCT00796939

Locations
United States, California
UCSD
La Jolla, California, United States, 92093
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Michael Grandner, PhD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00796939     History of Changes
Other Study ID Numbers: R01 MH068545, MH68545, DATR A3-NSS
Study First Received: November 21, 2008
Last Updated: December 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Delayed Sleep Phase Syndrome
Sleep

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014