NCT00796939

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

7 months

First QC Date

November 21, 2008

Last Update Submit

April 9, 2015

Conditions

Depression

Keywords

Delayed Sleep Phase SyndromeSleep

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

Green Light Mask

ACTIVE COMPARATOR
Device: Green light mask

Red light mask

PLACEBO COMPARATOR
Device: Red Light Mask

Interventions

Green light maskDEVICE

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

Green Light Mask
Red Light MaskDEVICE

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

Red light mask

Eligibility Criteria

Age25 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Presence of clinical depression
  • Presence of a sleep disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

DepressionSleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 24, 2008

Study Start

March 1, 2006

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

US(1)