Sleep Phase Rhythm DisturbanceNCT03010488
Are Bright Lights and Regulated Sleep Effective Treatment for Depression?
A study testing Morning Light Therapy, Assigned Sleep Times and Goggles in people with Sleep Phase Rhythm Disturbance and Sleep Deprivation, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Previous data suggest some depressed patients act as if their internal biological clock is out of sync with the outside world and re-aligning their clock with the timing of sunlight lessens their depressed mood and accompanying depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Phase Rhythm Disturbance, Sleep Deprivation
- What is being tested?
- Morning Light Therapy, Assigned Sleep Times and Goggles
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently Depressed
- In reasonably good physical health
Who cannot join
- Bipolar Disorder (I, II, or unspecified)
- History of psychosis
- Unstable medical condition
- Current (past 6 months) drug or alcohol use disorder
- Need for hospitalization
- Treating clinician determines not to include patient in this protocol
Show all 9Show fewer
- Currently taking medications approved for the treatment of depression
- Un- or poorly controlled hypertension
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Evaluation Service - New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Are Bright Lights and Regulated Sleep Effective Treatment for Depression.
Previous data suggest some depressed patients act as if their internal biological clock is out of sync with the outside world and re-aligning their clock with the timing of sunlight lessens their depressed mood and accompanying depressive symptoms. This "chronotherapy" may produce remission during the first week of treatment while causing minimal problems. This study aims to demonstrate the efficacy of chronotherapy by comparing two protocols for inducing sleep phase advance. Which chronotherapy condition a participant will receive will be determined randomly (i.e., by chance, essentially a computerized flip of a coin). Prior to determination of which protocol a patient will follow, each patient will declare their desired sleep time (for example, 11 p.m. to 7 a.m.). All patients will be assigned specific times to sleep and sit in front of bight lights wearing clear or amber goggles. Assigned sleep times will differ between groups using different strategies to shift the timing of their sleep from their ideal sleep time as determined by their Morningness-Eveningness Questionnaire (MEQ) score to their desired sleep time. All participants will be rated daily by telephone for the first week following randomization, and then weekly for an additional five weeks. Whenever possible, weekly visits will be in person, although telephone visits will be allowed. All participants will be rated at baseline, 1 week and 6 weeks by an Independent Evaluator blind to treatment assignment (as well as the nature of the treatment and if it has occurred or not). After the six week post-randomization evaluation, all participants will be offered six months of continued treatment and be rated monthly. Treatment during this six month period may consist of Chronotherapy or conventional antidepressants as the patient and doctor determine. Standard ratings of depression, over-all illness and functioning will be obtained. Change in the symptom measures will determine treatment efficacy. Analysis of saliva melatonin levels, sleep logs and activity monitor data will measure the timing of the biological clock and whether it has been shifted by the treatment. Measures of functioning will determine whether functioning improves coincident with, independent of, or subsequent to mood improvement.
Read the detailed description
This study will investigate the utility of regimented sleep and lights in depressed subjects. Based on current timing of sleep, desired sleep time and responses to the Morningness-Eveningness Questionnaire, each subject who remains significantly depressed at their randomization (usually 2nd) visit, will be randomly assigned to one of two regimented sleep and light use protocols. On the night beginning their assigned regimented protocol, each subject will wear amber goggles for five hours and collect half hourly saliva samples for four hours. Each morning they will sit in front of a light box wearing goggles. During the first week following the start of the regimented protocol, they will complete self-report forms and have a telephone interview to document their depressive symptoms. They will have weekly in person interviews for six weeks and evaluations by an independent evaluator in person or by telephone at randomization, 2 and 6 weeks. Prior to their Week 2 Visit, they will wear the goggles for the four hours prior to their assigned bedtime and for the three hours prior to their assigned bedtime, they will collect half hourly saliva samples. At their Week 6 interview, they and their doctor will determine whether they have improved sufficiently or not. Their doctor will discuss with them whether it makes sense for them to continue the same regimented sleep/light schedule, make a change to it or switch to or add additional treatment, such as antidepressant medication. They will then be followed with study ratings monthly for six months, during which treatment is unrestricted; that is, the doctor and patient can determine what the treatment during this time will be. Following the six months follow-up, a referral will be made if appropriate.
All saliva samples will be analyzed for melatonin concentration.
- Conditions
- Sleep Phase Rhythm Disturbance, Sleep Deprivation
- Being tested
- Morning Light Therapy, Assigned Sleep Times, Goggles
- Keywords
- Chronotherapy, Light Therapy
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning Light TherapyBehavioural
Also called Light Therapy
10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.
Assigned Sleep TimesBehavioural
Also called Sleep Phase Advance
Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.
GogglesDevice
Subjects will wear goggles during saliva collection and Bright Light Therapy
| Study group | Role | What they receive |
|---|---|---|
| Rapid Sleep Shift | Experimental | Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing goggles. Receives: Behavioral: Morning Light Therapy; Behavioral: Assigned Sleep Times; Device: Goggles |
| Gradual Sleep Shift | Active comparator | Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing goggles. Receives: Behavioral: Morning Light Therapy; Behavioral: Assigned Sleep Times; Device: Goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-Item Hamilton Rating Scale for Depression Score (Independent Evaluator)
Independent Evaluator's Week 6 17-item Hamilton Rating Scale for Depression Summary Score. The 17-item Hamilton is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the Hamilton list 24 items, the scoring is based on both the first 17 items and the full 24 items.
sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression >=23 = Very Severe Depression
Measured: Week 6
Secondary outcomes (1)
Participant Sleep Efficiency
Sleep Efficiency (percentage of time spent sleeping during target sleep period) as measured by activity monitor and sleep logs.
Sleep logs: Patients were instructed to record all sleep periods in the daily log by marking boxes representing 15-minute intervals. They were also requested to wear the Actigraph activity monitor at all times except for bathing, swimming, or any other activities requiring immersion of the wrist. In addition, patients were provided with schedules delineating their allowed sleep time each day.
Patients chose their target sleep times (an eight-hour time they desired their sleep to occur) and completed the Morningness-Eveningness Questionnaire (MEQ) to estimate the timing of their circadian clocks, including ideal sleep and wake-up times.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionJun 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Phase Rhythm DisturbanceStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David J. Hellerstein, New York State Psychiatric Institute
- Investigators
- Jonathan W Stewart, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010488
- Sponsor's protocol ID
- 7361
- Other IDs
- 7361
- Status last verified
- Feb 2021
- First submitted
- 3 Jan 2017
- Last updated
- 23 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: All non-identifiable data will be made available to qualified researchers on request to the study PI.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Bright Lights and Regulated Sleep Effective Treatment for Depression.
- ClinicalTrials.gov ID
- NCT03010488
- Acronym / sponsor ID
- 7361
- Conditions
- Sleep Phase Rhythm Disturbance, Sleep Deprivation
- Keywords
- Chronotherapy, Light Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Posted 23 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous data suggest some depressed patients act as if their internal biological clock is out of sync with the outside world and re-aligning their clock with the timing of sunlight lessens their depressed mood and accompanying depressive symptoms. This "chronotherapy" may produce remission during the first week of treatment while causing minimal problems. This study aims to demonstrate the efficacy of chronotherapy by comparing two protocols for inducing sleep phase advance. Which chronotherapy condition a participant will receive will be determined randomly (i.e., by chance, essentially a computerized flip of a coin). Prior to determination of which protocol a patient will follow, each patient will declare their desired sleep time (for example, 11 p.m. to 7 a.m.). All patients will be assigned specific times to sleep and sit in front of bight lights wearing clear or amber goggles. Assigned sleep times will differ between groups using different strategies to shift the timing of their sleep from their ideal sleep time as determined by their Morningness-Eveningness Questionnaire (MEQ) score to their desired sleep time. All participants will be rated daily by telephone for the first week following randomization, and then weekly for an additional five weeks. Whenever possible, weekly visits will be in person, although telephone visits will be allowed. All participants will be rated at baseline, 1 week and 6 weeks by an Independent Evaluator blind to treatment assignment (as well as the nature of the treatment and if it has occurred or not). After the six week post-randomization evaluation, all participants will be offered six months of continued treatment and be rated monthly. Treatment during this six month period may consist of Chronotherapy or conventional antidepressants as the patient and doctor determine. Standard ratings of depression, over-all illness and functioning will be obtained. Change in the symptom measures will determine treatment efficacy. Analysis of saliva melatonin levels, sleep logs and activity monitor data will measure the timing of the biological clock and whether it has been shifted by the treatment. Measures of functioning will determine whether functioning improves coincident with, independent of, or subsequent to mood improvement.
Detailed description
This study will investigate the utility of regimented sleep and lights in depressed subjects. Based on current timing of sleep, desired sleep time and responses to the Morningness-Eveningness Questionnaire, each subject who remains significantly depressed at their randomization (usually 2nd) visit, will be randomly assigned to one of two regimented sleep and light use protocols. On the night beginning their assigned regimented protocol, each subject will wear amber goggles for five hours and collect half hourly saliva samples for four hours. Each morning they will sit in front of a light box wearing goggles. During the first week following the start of the regimented protocol, they will complete self-report forms and have a telephone interview to document their depressive symptoms. They will have weekly in person interviews for six weeks and evaluations by an independent evaluator in person or by telephone at randomization, 2 and 6 weeks. Prior to their Week 2 Visit, they will wear the goggles for the four hours prior to their assigned bedtime and for the three hours prior to their assigned bedtime, they will collect half hourly saliva samples. At their Week 6 interview, they and their doctor will determine whether they have improved sufficiently or not. Their doctor will discuss with them whether it makes sense for them to continue the same regimented sleep/light schedule, make a change to it or switch to or add additional treatment, such as antidepressant medication. They will then be followed with study ratings monthly for six months, during which treatment is unrestricted; that is, the doctor and patient can determine what the treatment during this time will be. Following the six months follow-up, a referral will be made if appropriate.
All saliva samples will be analyzed for melatonin concentration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid Sleep Shift | Experimental | Behavioral: Morning Light Therapy, Behavioral: Assigned Sleep Times, Device: GogglesAssigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing goggles. |
| Gradual Sleep Shift | Active comparator | Behavioral: Morning Light Therapy, Behavioral: Assigned Sleep Times, Device: GogglesAssigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing goggles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently Depressed
- In reasonably good physical health
Key exclusion criteria (9 listed)
- Bipolar Disorder (I, II, or unspecified)
- History of psychosis
- Unstable medical condition
- Current (past 6 months) drug or alcohol use disorder
- Need for hospitalization
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 |
|---|---|---|
| Morning Light TherapyAlso: Light Therapy10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time. | Behavioural | Gradual Sleep Shift, Rapid Sleep Shift |
| Assigned Sleep TimesAlso: Sleep Phase AdvanceSleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation. | Behavioural | Gradual Sleep Shift, Rapid Sleep Shift |
| GogglesSubjects will wear goggles during saliva collection and Bright Light Therapy | Device | Gradual Sleep Shift, Rapid Sleep Shift |
Primary outcome
17-Item Hamilton Rating Scale for Depression Score (Independent Evaluator)
Time frame: Week 6
Independent Evaluator's Week 6 17-item Hamilton Rating Scale for Depression Summary Score. The 17-item Hamilton is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the Hamilton list 24 items, the scoring is based on both the first 17 items and the full 24 items. sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression >=23 = Very Severe Depression
1 secondary outcome
Participant Sleep Efficiency
Time frame: Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All non-identifiable data will be made available to qualified researchers on request to the study PI.
Related trials for Sleep Phase Rhythm Disturbance
Recruiting
PICU-related Sleep and Circadian Dysregulation Pilot Study
Circadian Dysrhythmia, Sleep Disturbance
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.
Jonathan W Stewart, MD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning Light Therapy, Assigned Sleep Times and Goggles in people with Sleep Phase Rhythm Disturbance and Sleep Deprivation, run by New York State Psychiatric Institute 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 2 inclusion and 9 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 23 Mar 2021. 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. 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?
Yes. Results are posted in the registry (first posted 23 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
17-Item Hamilton Rating Scale for Depression Score (Independent Evaluator) (time frame: Week 6). 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 23 Mar 2021.