Trial Outcomes & Findings for Morning Light Treatment at Home to Reduce PTSD Symptoms (NCT NCT03513848)
NCT ID: NCT03513848
Last Updated: 2019-10-23
Results Overview
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 \[Week 2 through Week 6 of the study\].
COMPLETED
NA
15 participants
Week 2 and Week 6
2019-10-23
Participant Flow
Participant milestones
| Measure |
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.
|
Dim Light
Retimer placebo: The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
|
Overall Study
COMPLETED
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Morning Light Treatment at Home to Reduce PTSD Symptoms
Baseline characteristics by cohort
| Measure |
Bright Light
n=9 Participants
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.
|
Dim Light
n=6 Participants
Retimer placebo: The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.89 years
STANDARD_DEVIATION 9.36 • n=99 Participants
|
51.00 years
STANDARD_DEVIATION 13.33 • n=107 Participants
|
44.93 years
STANDARD_DEVIATION 11.83 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
6 participants
n=107 Participants
|
15 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 2 and Week 6The 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 \[Week 2 through Week 6 of the study\].
Outcome measures
| Measure |
Bright Light
n=9 Participants
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.
|
Dim Light
n=6 Participants
Retimer placebo: The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.
|
|---|---|---|
|
Change in PTSD Checklist for DSM-5 (PCL-5) Scores Over 4 Weeks of Treatment
|
15.11 units on a scale
Standard Deviation 14.38
|
2.50 units on a scale
Standard Deviation 7.50
|
SECONDARY outcome
Timeframe: Week 2 and Week 6The 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 \[Week 2 through Week 6 of the study\].
Outcome measures
| Measure |
Bright Light
n=9 Participants
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.
|
Dim Light
n=6 Participants
Retimer placebo: The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.
|
|---|---|---|
|
Change in Patient Health Questionnaire - 9 (PHQ-9) Scores Over 4 Weeks of Treatment
|
4.78 units on a scale
Standard Deviation 3.73
|
1.17 units on a scale
Standard Deviation 5.95
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 2 and Week 6Sleep 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 \[Week 2 through Week 6 of the study\].
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 2 and Week 6Sleep 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 \[Week 2 through Week 6 of the study\].
Outcome measures
Outcome data not reported
Adverse Events
Bright Light
Dim Light
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bright Light
n=9 participants at risk
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.
|
Dim Light
n=6 participants at risk
Retimer placebo: The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.
|
|---|---|---|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected over the 4 weeks of light treatment.
|
0.00%
0/6 • Adverse event data were collected over the 4 weeks of light treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place