Trial Outcomes & Findings for Effects of Bright Light Therapy in Mild Traumatic Brain Injury (NCT NCT01747811)
NCT ID: NCT01747811
Last Updated: 2017-06-01
Results Overview
The MSLT is a objective measure of sleepiness. Participants will take a brief nap 3 times during the 1st and second visit. The period of time between wake and sleep onset will be utilized as an objective measure of sleepiness (in minutes). A mean value will be calculated for the entirety of the pre-treatment napping periods and for the post treatment visits.
COMPLETED
NA
32 participants
Change from baseline performance at 6 weeks (post-treatment)
2017-06-01
Participant Flow
Participant milestones
| Measure |
Wavelength-1 Bright Light
30 minutes daily light exposure for 6 weeks
|
Wavelength-2 Bright Light
30 minutes daily light exposure for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Wavelength-1 Bright Light
30 minutes daily light exposure for 6 weeks
|
Wavelength-2 Bright Light
30 minutes daily light exposure for 6 weeks
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
4
|
Baseline Characteristics
Effects of Bright Light Therapy in Mild Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Wavelength-1 Bright Light
n=14 Participants
30 minutes daily light exposure for 6 weeks
wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
Wavelength-2 Bright Light
n=12 Participants
30 minutes daily light exposure for 6 weeks
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
23.07 Years
STANDARD_DEVIATION 7.50 • n=5 Participants
|
23.46 Years
STANDARD_DEVIATION 8.64 • n=7 Participants
|
23.24 Years
STANDARD_DEVIATION 7.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline performance at 6 weeks (post-treatment)The MSLT is a objective measure of sleepiness. Participants will take a brief nap 3 times during the 1st and second visit. The period of time between wake and sleep onset will be utilized as an objective measure of sleepiness (in minutes). A mean value will be calculated for the entirety of the pre-treatment napping periods and for the post treatment visits.
Outcome measures
| Measure |
Wavelength-1 Bright Light
n=14 Participants
30 minutes daily light exposure for 6 weeks
wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
Wavelength-2 Bright Light
n=12 Participants
30 minutes daily light exposure for 6 weeks
|
|---|---|---|
|
Performance on Multiple Sleep Latency Test (MSLT)
MSLT_PreTreatment_Sleep Onset Latency (SOL)
|
6.67 minutes
Standard Deviation 3.91
|
7.32 minutes
Standard Deviation 5.41
|
|
Performance on Multiple Sleep Latency Test (MSLT)
MSLT_PostTreatment_Sleep Onset Latency (SOL)
|
6.73 minutes
Standard Deviation 5.98
|
7.88 minutes
Standard Deviation 5.83
|
SECONDARY outcome
Timeframe: Change from baseline performance at 6 weeks (post-treatment)Population: A total of 22 participants had useable data, 4 participants were excluded due to movement in the images.
Change from baseline in left prefrontal cortical response during a multi source interference task at six weeks. Methods utilized to assess activity in the left prefrontal cortex/inferior frontal operculum included a regions of interest analysis.
Outcome measures
| Measure |
Wavelength-1 Bright Light
n=13 Participants
30 minutes daily light exposure for 6 weeks
wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
Wavelength-2 Bright Light
n=9 Participants
30 minutes daily light exposure for 6 weeks
|
|---|---|---|
|
Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Executive Function Task
|
0.098 Percent Signal Change
Standard Deviation 0.106
|
-0.025 Percent Signal Change
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: Change from baseline at 6 weeks (post-treatment)The Pittsburgh Sleep Quality Index is a self report measure of sleep quality. The overall score takes into account many different facets of sleep, such as sleep quality, sleep latency, sleep duration, sleep disturbances, etc. The scores range from 0-21, and any score that is equal to or greater than 5 is indicative of poor sleep quality.
Outcome measures
| Measure |
Wavelength-1 Bright Light
n=14 Participants
30 minutes daily light exposure for 6 weeks
wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
Wavelength-2 Bright Light
n=12 Participants
30 minutes daily light exposure for 6 weeks
|
|---|---|---|
|
Score on Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index_Mean_PreTreatment
|
6.50 units on a scale
Standard Deviation 2.14
|
8.25 units on a scale
Standard Deviation 1.60
|
|
Score on Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index_Mean_PostTreatment
|
4.79 units on a scale
Standard Deviation 2.29
|
6.25 units on a scale
Standard Deviation 3.19
|
SECONDARY outcome
Timeframe: Change from baseline at 6 weeks (post-treatment)Population: We collected usable actigraphy from 29 participants. The 7 remaining participants had unusable actigraphy data.
Actigraphy is an objective measure that determines sleep vs. wake. It is a watch with an accelerometer worn on the wrist. Sleep quality is determined by the amount of time in bed divided by the amount of time sleeping (in minutes).
Outcome measures
| Measure |
Wavelength-1 Bright Light
n=14 Participants
30 minutes daily light exposure for 6 weeks
wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
Wavelength-2 Bright Light
n=12 Participants
30 minutes daily light exposure for 6 weeks
|
|---|---|---|
|
Actigraphy-measured Sleep Quality
|
86.17 minutes
Standard Deviation 1.60
|
85.70 minutes
Standard Deviation 5.21
|
SECONDARY outcome
Timeframe: Change from baseline at 6 weeks (post-treatment)The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a neuropsychological assessment that measures different facets of memory including the following: immediate memory, visuospatial/constructional, language, attention, and delayed memory. This is given to all participants on both pre and post treatment visits. The total range for this scale is 40-160. Lower values represent a worse outcome, and higher values represent an improved outcome.
Outcome measures
| Measure |
Wavelength-1 Bright Light
n=14 Participants
30 minutes daily light exposure for 6 weeks
wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
Wavelength-2 Bright Light
n=12 Participants
30 minutes daily light exposure for 6 weeks
|
|---|---|---|
|
Performance on Neuropsychological Assessment
Pre-treatment
|
102.71 units on a scale
Standard Deviation 9.55
|
101.67 units on a scale
Standard Deviation 19.01
|
|
Performance on Neuropsychological Assessment
Post Treatment
|
98.50 units on a scale
Standard Deviation 9.20
|
95.33 units on a scale
Standard Deviation 15.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline at 6 weeks (post-treatment)The Beck Depression Inventory (BDI-II) is a self report scale utilized for measuring the severity of depression. Scores can range from 0-63 (0 meaning minimal depressive symptoms, and 63 being severe depressive symptoms). Participants are given this on baseline and post treatment.
Outcome measures
| Measure |
Wavelength-1 Bright Light
n=14 Participants
30 minutes daily light exposure for 6 weeks
wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
Wavelength-2 Bright Light
n=12 Participants
30 minutes daily light exposure for 6 weeks
|
|---|---|---|
|
Change From Baseline in Beck Depression Inventory (BDI-II) Scores at 6 Weeks
|
4.00 units on a scale
Standard Deviation 5.07
|
4.83 units on a scale
Standard Deviation 3.88
|
Adverse Events
Wavelength-1 Bright Light
Wavelength-2 Bright Light
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place