Trial Outcomes & Findings for Improving Sleep in Veterans With TBI (NCT NCT03785600)
NCT ID: NCT03785600
Last Updated: 2025-09-22
Results Overview
NIH Patient Reported Outcomes Measurement Information System (PROMIS) pain interference short-form 4a. 4 questions; each question is a 1-5 Likert scale, total score range is 4-20. Higher scores represent greater pain interference. \*all are reported as total score, no subscale scores present.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
77 participants
Primary outcome timeframe
Pre- and post-4 weeks of Morning Bright Light Therapy (MBLT) or sham treatment.
Results posted on
2025-09-22
Participant Flow
Participant milestones
| Measure |
Morning Bright Light Therapy
Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
Morning Bright Light Therapy: Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
|
Negative Ion Generator
Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
Negative Ion Generator: Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
24
|
|
Overall Study
COMPLETED
|
44
|
20
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Sleep in Veterans With TBI
Baseline characteristics by cohort
| Measure |
Morning Bright Light Therapy
n=44 Participants
Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
Morning Bright Light Therapy: Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
|
Negative Ion Generator
n=20 Participants
Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
Negative Ion Generator: Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
51.8 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
53.1 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Years of Education
|
16.5 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
15.6 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
16.2 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Pre- and post-4 weeks of Morning Bright Light Therapy (MBLT) or sham treatment.NIH Patient Reported Outcomes Measurement Information System (PROMIS) pain interference short-form 4a. 4 questions; each question is a 1-5 Likert scale, total score range is 4-20. Higher scores represent greater pain interference. \*all are reported as total score, no subscale scores present.
Outcome measures
| Measure |
Morning Bright Light Therapy
n=44 Participants
Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
Morning Bright Light Therapy: Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
|
Negative Ion Generator
n=20 Participants
Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
Negative Ion Generator: Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
|
|---|---|---|
|
Change in Self-reported Pain
Mean Pre-Intervention Pain Interference
|
9.8 Score on Pain Interference
Standard Deviation 4.8
|
10.2 Score on Pain Interference
Standard Deviation 4.7
|
|
Change in Self-reported Pain
Mean Post-Intervention Pain Interference
|
9.3 Score on Pain Interference
Standard Deviation 4.8
|
10.0 Score on Pain Interference
Standard Deviation 5.0
|
Adverse Events
Morning Bright Light Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Negative Ion Generator
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Morning Bright Light Therapy
n=53 participants at risk
Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
Morning Bright Light Therapy: Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
|
Negative Ion Generator
n=24 participants at risk
Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
Negative Ion Generator: Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
|
|---|---|---|
|
Psychiatric disorders
Non-Serious
|
0.00%
0/53 • Adverse event data was collected started immediately after consent and ended after participants completed all study activities (up to 20 weeks).
|
4.2%
1/24 • Number of events 1 • Adverse event data was collected started immediately after consent and ended after participants completed all study activities (up to 20 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place