Effects of Light Treatment During Sleep on Young Men

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

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

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Device: Green light mask; Device: Red Light Mask

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • UCSD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Exclusion Criteria:

• Presence of clinical depression
• Presence of a sleep disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety, measured through the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire	Measured on Days 3 and 15
Tolerability, measured through compliance reports	Measured daily for the length of the study
Mood disturbance, measured on the Quick Inventory of Depressive Symptomology-Self Report (QIDS-SR)	Measured on Days 3 and 15

Secondary Outcome Measures

Outcome Measure	Time Frame
Sleep diary	Measured daily for the duration of the study
Mood visual analog scale	Measured daily for the duration of the study
Luteinizing hormone, measured through urinalysis	Measured on Days 3 and 13
Testosterone, measured through saliva analysis	Measured on Days 3 and 13

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: November 21, 2008
• First Submitted That Met QC Criteria: November 21, 2008
• First Posted (Estimate): November 24, 2008

Study Record Updates

• Last Update Posted (Estimate): April 10, 2015
• Last Update Submitted That Met QC Criteria: April 9, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Sleep; Delayed Sleep Phase Syndrome
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: R01MH068545 (U.S. NIH Grant/Contract); MH68545; DATR A3-NSS (Indiana University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No