An interventional study of Morning Light Therapy and Assigned Sleep Times in Sleep Phase Rhythm Disturbance and Sleep Deprivation, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-03-23.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Treatment
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.
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.
300 studies on the registry are indexed under Sleep Deprivation; 60 are open to participants now.
This study's enrollment of 44 is close to the median of 45 across 248 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing goggles.
Behavioral: Morning Light Therapy · Behavioral: Assigned Sleep Times · Device: Goggles
Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing goggles.
Behavioral: Morning Light Therapy · Behavioral: Assigned Sleep Times · Device: Goggles
10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.
Also known as: Light Therapy
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.
Also known as: Sleep Phase Advance
Subjects will wear goggles during saliva collection and Bright Light Therapy
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
Time frame: Week 6
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.
Time frame: Week 6
| Milestone | Rapid Sleep Shift | Gradual Sleep Shift |
|---|---|---|
| Started | 22 | 22 |
| Completed | 17 | 15 |
| Not completed | 5 | 7 |
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
| units on a scale | Rapid Sleep Shift | Gradual Sleep Shift |
|---|---|---|
| 17-Item Hamilton Rating Scale for Depression Score (Independent Evaluator) | 8.66 ± 6.09 | 10.46 ± 7.79 |
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.
| percentage of time | Rapid Sleep Shift | Gradual Sleep Shift |
|---|---|---|
| Participant Sleep Efficiency | 76.43 ± 10.82 | 68.23 ± 28.27 |
Collected over 7.5 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rapid Sleep Shift | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Gradual Sleep Shift | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Continuous(years) | Rapid Sleep Shift | Gradual Sleep Shift | Total |
|---|---|---|---|
| Mean | 37.8 ± 14.3 | 38.8 ± 16.4 | 38.3 ± 15.2 |
| Sex: Female, Male(Participants) | Rapid Sleep Shift | Gradual Sleep Shift | Total |
|---|---|---|---|
| Female | 12 | 12 | 24 |
| Male | 10 | 10 | 20 |
| Race (NIH/OMB)(Participants) | Rapid Sleep Shift | Gradual Sleep Shift | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 17 | 17 | 34 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 2 | 2 | 4 |
| Region of Enrollment(participants) | Rapid Sleep Shift | Gradual Sleep Shift | Total |
|---|---|---|---|
| United States | 22 | 22 | 44 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All non-identifiable data will be made available to qualified researchers on request to the study PI.
Supporting information: Study protocol, Icf, Csr, Analytic code
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New York State Psychiatric Institute