DepressionNCT00796939
Effects of Light Treatment During Sleep on Young Men
A study testing Green light mask and Red Light Mask in people with Depression, run by University of California, San Diego at 1 site in United States.
Trial summary
This study will determine if green light exposure during sleep is effective in reducing mild depression symptoms in young men. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Green light mask and Red Light Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Oct 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Presence of clinical depression
- Presence of a sleep disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression
- Being tested
- Green light mask, Red Light Mask
- Keywords
- Delayed Sleep Phase Syndrome, Sleep
- Medical subject headings
- Depression, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green light maskDevice
Participants will receive approximately 10,000 lux from green light-emitting diodes.
Red Light MaskDevice
Participants will receive approximately 0.5 lux from white light-emitting diodes covered by a red gel.
| Study group | Role | What they receive |
|---|---|---|
| Green Light Mask | Active comparator | Not described Receives: Device: Green light mask |
| Red light mask | Placebo comparator | Not described Receives: Device: Red Light Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, measured through the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire
Measured: Measured on Days 3 and 15
Tolerability, measured through compliance reports
Measured: Measured daily for the length of the study
Mood disturbance, measured on the Quick Inventory of Depressive Symptomology-Self Report (QIDS-SR)
Measured: Measured on Days 3 and 15
Secondary outcomes (4)
Sleep diary
Measured: Measured daily for the duration of the study
Mood visual analog scale
Measured: Measured daily for the duration of the study
Luteinizing hormone, measured through urinalysis
Measured: Measured on Days 3 and 13
Testosterone, measured through saliva analysis
Measured: Measured on Days 3 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startMar 2006
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796939
- Sponsor's protocol ID
- R01MH068545
- Other IDs
- R01MH068545, MH68545, DATR A3-NSS
- Status last verified
- Apr 2015
- First submitted
- 21 Nov 2008
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled Trial of Short Wavelength Light Administered Just Prior to Waking in Young Men
- ClinicalTrials.gov ID
- NCT00796939
- Acronym / sponsor ID
- R01MH068545
- Conditions
- Depression
- Keywords
- Delayed Sleep Phase Syndrome, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine if green light exposure during sleep is effective in reducing mild depression symptoms in young men.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green Light Mask | Active comparator | Device: Green light mask |
| Red light mask | Placebo comparator | Device: Red Light Mask |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Presence of clinical depression
- Presence of a sleep disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green light maskParticipants will receive approximately 10,000 lux from green light-emitting diodes. | Device | Green Light Mask |
| Red Light MaskParticipants will receive approximately 0.5 lux from white light-emitting diodes covered by a red gel. | Device | Red light mask |
Primary outcome
Safety, measured through the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire
Time frame: Measured on Days 3 and 15
Tolerability, measured through compliance reports
Time frame: Measured daily for the length of the study
Mood disturbance, measured on the Quick Inventory of Depressive Symptomology-Self Report (QIDS-SR)
Time frame: Measured on Days 3 and 15
4 secondary outcomes
Sleep diary
Time frame: Measured daily for the duration of the study
Mood visual analog scale
Time frame: Measured daily for the duration of the study
Luteinizing hormone, measured through urinalysis
Time frame: Measured on Days 3 and 13
Testosterone, measured through saliva analysis
Time frame: Measured on Days 3 and 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green light mask and Red Light Mask in people with Depression, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, measured through the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire (time frame: Measured on Days 3 and 15). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.