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There is evidence that some of the circadian photoreceptors, the intrinsically photosensitive retinal ganglion cells (ipRGCs), project directly to the amygdala, an area of the brain implicated in PTSD. Thus, a self-administered morning light treatment at home (shifts clock earlier and stimulates ipRGCs) may be a potentially efficacious adjunctive strategy for reducing PTSD symptoms. This study will test a 4 week daily 1 hour morning light treatment (active vs placebo) in individuals with PTSD. Outcome measures include measures of PTSD and depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright Light | Experimental |
| |
| Dim Light | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retimer | Device | The Retimer light device in this study is a commercially-available wearable light device. It permits ambulation while receiving light from LEDs positioned below the eyes. The LEDs emit green light (~500nm, 230 µW/m2, 500 lux), close to the peak sensitivity of circadian photoreceptors. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD Checklist for DSM-5 (PCL-5) Scores Over 4 Weeks of Treatment | The PTSD Checklist for DSM-5 (PCL-5) is the gold standard measure of PTSD symptom severity. Range: 0-80. Higher scores indicate worse outcomes. We will assess change in PCL-5 scores over 4 weeks of treatment [Week 2 through Week 6 of the study]. | Week 2 and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Health Questionnaire - 9 (PHQ-9) Scores Over 4 Weeks of Treatment | The Patient Health Questionnaire - 9 (PHQ-9) is the gold standard measure of depression symptom severity. Range: 0-27. Higher scores indicate worse outcomes. We will assess change in PHQ-9 scores over 4 weeks of treatment [Week 2 through Week 6 of the study]. | Week 2 and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Duration Over 4 Weeks of Treatment | Sleep duration will be captured using actigraphy data collected by the wrist actigraphy monitor worn by subjects throughout the intervention. We will assess change in sleep duration over 4 weeks of treatment [Week 2 through Week 6 of the study]. | Week 2 and Week 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alyson Zalta, PhD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bright Light | Retimer: The Retimer light device in this study is a commercially-available wearable light device. It permits ambulation while receiving light from LEDs positioned below the eyes. The LEDs emit green light (~500nm, 230 µW/m2, 500 lux), close to the peak sensitivity of circadian photoreceptors. |
| FG001 | Dim Light | Retimer placebo: The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bright Light | Retimer: The Retimer light device in this study is a commercially-available wearable light device. It permits ambulation while receiving light from LEDs positioned below the eyes. The LEDs emit green light (~500nm, 230 µW/m2, 500 lux), close to the peak sensitivity of circadian photoreceptors. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in PTSD Checklist for DSM-5 (PCL-5) Scores Over 4 Weeks of Treatment | The PTSD Checklist for DSM-5 (PCL-5) is the gold standard measure of PTSD symptom severity. Range: 0-80. Higher scores indicate worse outcomes. We will assess change in PCL-5 scores over 4 weeks of treatment [Week 2 through Week 6 of the study]. | Posted | Mean | Standard Deviation | units on a scale | Week 2 and Week 6 |
|
Adverse event data were collected over the 4 weeks of light treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bright Light | Retimer: The Retimer light device in this study is a commercially-available wearable light device. It permits ambulation while receiving light from LEDs positioned below the eyes. The LEDs emit green light (~500nm, 230 µW/m2, 500 lux), close to the peak sensitivity of circadian photoreceptors. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment | Mild headache |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alyson Zalta | University of California, Irvine | 949-824-3409 | azalta@uci.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2018 | Oct 21, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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|
| Retimer placebo | Device | The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing. |
|
| Change in Sleep Quality Over 4 Weeks of Treatment |
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) with PTSD addendum. We will assess change in sleep quality over 4 weeks of treatment [Week 2 through Week 6 of the study]. |
| Week 2 and Week 6 |
| Dim Light |
Retimer placebo: The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Retimer placebo: The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.
|
|
| Secondary | Change in Patient Health Questionnaire - 9 (PHQ-9) Scores Over 4 Weeks of Treatment | The Patient Health Questionnaire - 9 (PHQ-9) is the gold standard measure of depression symptom severity. Range: 0-27. Higher scores indicate worse outcomes. We will assess change in PHQ-9 scores over 4 weeks of treatment [Week 2 through Week 6 of the study]. | Posted | Mean | Standard Deviation | units on a scale | Week 2 and Week 6 |
|
|
|
| Other Pre-specified | Change in Sleep Duration Over 4 Weeks of Treatment | Sleep duration will be captured using actigraphy data collected by the wrist actigraphy monitor worn by subjects throughout the intervention. We will assess change in sleep duration over 4 weeks of treatment [Week 2 through Week 6 of the study]. | Not Posted | Week 2 and Week 6 | Participants |
| Other Pre-specified | Change in Sleep Quality Over 4 Weeks of Treatment | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) with PTSD addendum. We will assess change in sleep quality over 4 weeks of treatment [Week 2 through Week 6 of the study]. | Not Posted | Week 2 and Week 6 | Participants |
| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Dim Light | Retimer placebo: The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing. | 0 | 6 | 0 | 6 | 0 | 6 |
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