Trial Outcomes & Findings for Bright Light Therapy for Treatment of Sleep Problems Following Mild Traumatic Brain Injury (NCT NCT02374918)
NCT ID: NCT02374918
Last Updated: 2021-06-24
Results Overview
The Pittsburgh Sleep Quality Index (PSQI) subscale measurement that was used is overall sleep quality, which is derived from question 6 on the assessment and uses a Likert scale of 0 to 3. A score of 0 represents "very good" sleep quality (better outcome), while a measurement of 3 represents "very bad" sleep quality (worse outcome).
COMPLETED
NA
77 participants
Post 6-week intervention
2021-06-24
Participant Flow
Participants were recruited from around the city of Tucson. The first participant was enrolled in December 2014. The Effect Localization Arm completed enrollment in April 2015 and the Treatment Arm completed enrollment in May 2019.
No pre-assignment criteria were needed after enrollment but before study group assignment for the Effect Localization Arm. For the Treatment Arm, participants went through a screening visit before study group assignment and were excluded based on the inclusion/exclusion criteria.
Participant milestones
| Measure |
mTBI Wavelength-1 Bright Light
30 minutes daily light exposure for 6 weeks
mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
mTBI Wavelength-2 Bright Light
30 minutes daily light exposure for 6 weeks
mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
HC Wavelength-1 Bright Light
30 minutes of light exposure
HC wavelength-1 bright light: 30 minutes of light exposure
|
HC Wavelength-2 Bright Light
30 minutes of light exposure
HC wavelength-2 bright light: 30 minutes of light exposure
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
22
|
20
|
|
Overall Study
COMPLETED
|
14
|
17
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
4
|
2
|
Reasons for withdrawal
| Measure |
mTBI Wavelength-1 Bright Light
30 minutes daily light exposure for 6 weeks
mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
mTBI Wavelength-2 Bright Light
30 minutes daily light exposure for 6 weeks
mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
HC Wavelength-1 Bright Light
30 minutes of light exposure
HC wavelength-1 bright light: 30 minutes of light exposure
|
HC Wavelength-2 Bright Light
30 minutes of light exposure
HC wavelength-2 bright light: 30 minutes of light exposure
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
1
|
Baseline Characteristics
The RPCSQ was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
Baseline characteristics by cohort
| Measure |
mTBI Wavelength-1 Bright Light
n=17 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
mTBI Wavelength-2 Bright Light
n=18 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
HC Wavelength-1 Bright Light
n=18 Participants
30 minutes of light exposure
HC wavelength-1 bright light: 30 minutes of light exposure
|
HC Wavelength-2 Bright Light
n=18 Participants
30 minutes of light exposure
HC wavelength-2 bright light: 30 minutes of light exposure
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=17 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
7 Participants
n=71 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=17 Participants
|
17 Participants
n=18 Participants
|
17 Participants
n=18 Participants
|
16 Participants
n=18 Participants
|
64 Participants
n=71 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=71 Participants
|
|
Age, Continuous
|
25.53 years
STANDARD_DEVIATION 8.65 • n=17 Participants
|
26.23 years
STANDARD_DEVIATION 7.62 • n=18 Participants
|
21.61 years
STANDARD_DEVIATION 2.86 • n=18 Participants
|
22.28 years
STANDARD_DEVIATION 4.03 • n=18 Participants
|
23.95 years
STANDARD_DEVIATION 6.41 • n=71 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=17 Participants
|
10 Participants
n=18 Participants
|
9 Participants
n=18 Participants
|
10 Participants
n=18 Participants
|
41 Participants
n=71 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=17 Participants
|
8 Participants
n=18 Participants
|
9 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
30 Participants
n=71 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=17 Participants
|
3 Participants
n=18 Participants
|
3 Participants
n=18 Participants
|
6 Participants
n=18 Participants
|
14 Participants
n=71 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=17 Participants
|
15 Participants
n=18 Participants
|
15 Participants
n=18 Participants
|
12 Participants
n=18 Participants
|
57 Participants
n=71 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=71 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=18 Participants
|
5 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=17 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=71 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=17 Participants
|
17 Participants
n=18 Participants
|
15 Participants
n=18 Participants
|
15 Participants
n=18 Participants
|
63 Participants
n=71 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=71 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=17 Participants
|
18 participants
n=18 Participants
|
18 participants
n=18 Participants
|
18 participants
n=18 Participants
|
67 participants
n=71 Participants
|
|
Post-Concussive Symptoms - Rivermead Post-Concussion Symptoms Questionnaire
RPQ3
|
3.3 units on a scale
STANDARD_DEVIATION 3 • n=17 Participants • The RPCSQ was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
3.5 units on a scale
STANDARD_DEVIATION 2.5 • n=18 Participants • The RPCSQ was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
—
|
—
|
3.4 units on a scale
STANDARD_DEVIATION 2.7 • n=35 Participants • The RPCSQ was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
|
Post-Concussive Symptoms - Rivermead Post-Concussion Symptoms Questionnaire
RPQ13
|
12.3 units on a scale
STANDARD_DEVIATION 13 • n=17 Participants • The RPCSQ was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
15.9 units on a scale
STANDARD_DEVIATION 8 • n=18 Participants • The RPCSQ was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
—
|
—
|
14.1 units on a scale
STANDARD_DEVIATION 10.9 • n=35 Participants • The RPCSQ was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
|
Sleep Quality - PSQI
|
1.44 units on a scale
STANDARD_DEVIATION 0.7 • n=17 Participants • The PSQI was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
1.76 units on a scale
STANDARD_DEVIATION 0.66 • n=18 Participants • The PSQI was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
—
|
—
|
1.60 units on a scale
STANDARD_DEVIATION 0.69 • n=35 Participants • The PSQI was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
|
Actigraphy - Sleep Efficiency
|
82.53 Percentage of time asleep
STANDARD_DEVIATION 4.83 • n=17 Participants • Actigraphy was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
80.98 Percentage of time asleep
STANDARD_DEVIATION 4.71 • n=18 Participants • Actigraphy was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
—
|
—
|
81.73 Percentage of time asleep
STANDARD_DEVIATION 4.63 • n=35 Participants • Actigraphy was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
|
Actigraphy - Wake After Sleep Onset (WASO)
|
11.2 Minutes
STANDARD_DEVIATION 3.02 • n=17 Participants • Actigraphy data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
11.97 Minutes
STANDARD_DEVIATION 3.23 • n=18 Participants • Actigraphy data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
—
|
—
|
11.60 Minutes
STANDARD_DEVIATION 3.06 • n=35 Participants • Actigraphy data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
|
RBANS total score (index)
|
88.2 units on a scale
STANDARD_DEVIATION 10 • n=17 Participants • RBANS data was not collected for the HC wavelength-1 and HC wavelength-2 arms.
|
96.1 units on a scale
STANDARD_DEVIATION 11.5 • n=18 Participants • RBANS data was not collected for the HC wavelength-1 and HC wavelength-2 arms.
|
—
|
—
|
92.53 units on a scale
STANDARD_DEVIATION 11.4 • n=35 Participants • RBANS data was not collected for the HC wavelength-1 and HC wavelength-2 arms.
|
|
PVT average speed - Run 1
|
3.27 responses/second
STANDARD_DEVIATION 0.41 • n=17 Participants • PVT data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
3.52 responses/second
STANDARD_DEVIATION 0.35 • n=18 Participants • PVT data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
—
|
—
|
3.39 responses/second
STANDARD_DEVIATION 0.39 • n=35 Participants • PVT data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
|
PVT average speed - Run 2
|
3.22 responses/second
STANDARD_DEVIATION 0.51 • n=17 Participants • PVT data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
3.45 responses/second
STANDARD_DEVIATION 0.42 • n=18 Participants • PVT data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
—
|
—
|
3.33 responses/second
STANDARD_DEVIATION 0.48 • n=35 Participants • PVT data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
|
PVT average speed - Run 3
|
3.17 responses/second
STANDARD_DEVIATION 0.43 • n=17 Participants • PVT data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
3.50 responses/second
STANDARD_DEVIATION 0.59 • n=18 Participants • PVT data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
—
|
—
|
3.33 responses/second
STANDARD_DEVIATION 0.53 • n=35 Participants • PVT data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
|
ANAM Code Substitution Learning - thruput score
|
46.78 correct responses/minute
STANDARD_DEVIATION 14.74 • n=17 Participants • ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
55.88 correct responses/minute
STANDARD_DEVIATION 12.39 • n=18 Participants • ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
—
|
—
|
51.20 correct responses/minute
STANDARD_DEVIATION 13.79 • n=35 Participants • ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
|
ANAM Procedural Reaction Time - thruput score
|
86.83 correct responses/minute
STANDARD_DEVIATION 19.55 • n=17 Participants • ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
97.06 correct responses/minute
STANDARD_DEVIATION 19.41 • n=18 Participants • ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
—
|
—
|
95.26 correct responses/minute
STANDARD_DEVIATION 17.98 • n=35 Participants • ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
|
ANAM Mathematical Processing - thruput score
|
17.89 correct responses/minute
STANDARD_DEVIATION 8.44 • n=17 Participants • ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
21.18 correct responses/minute
STANDARD_DEVIATION 7.38 • n=18 Participants • ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
—
|
—
|
19.49 correct responses/minute
STANDARD_DEVIATION 7.89 • n=35 Participants • ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
|
ANAM Matching to Sample - thruput score
|
29.5 correct responses/minute
STANDARD_DEVIATION 8.05 • n=17 Participants • ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
33.29 correct responses/minute
STANDARD_DEVIATION 11.55 • n=18 Participants • ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
—
|
—
|
31.34 correct responses/minute
STANDARD_DEVIATION 9.86 • n=35 Participants • ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
|
ANAM Code Substitution delay - thruput score
|
41.06 correct responses/minute
STANDARD_DEVIATION 13.11 • n=17 Participants • ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
52.88 correct responses/minute
STANDARD_DEVIATION 8.72 • n=18 Participants • ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
—
|
—
|
46.8 correct responses/minute
STANDARD_DEVIATION 11.96 • n=35 Participants • ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
|
ESS total score
|
8.72 units on a scale
STANDARD_DEVIATION 3.32 • n=17 Participants • ESS data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
8.18 units on a scale
STANDARD_DEVIATION 3.28 • n=18 Participants • ESS data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
—
|
—
|
8.46 units on a scale
STANDARD_DEVIATION 3.27 • n=35 Participants • ESS data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
|
FOSQ Total Score
|
17.10 units on a scale
STANDARD_DEVIATION 2.18 • n=17 Participants • FOSQ data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
15.37 units on a scale
STANDARD_DEVIATION 3.82 • n=18 Participants • FOSQ data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
—
|
—
|
14.06 units on a scale
STANDARD_DEVIATION 10.86 • n=35 Participants • FOSQ data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
|
PRIMARY outcome
Timeframe: Post 6-week interventionPopulation: The PSQI was not administered to the HC wavelength-2 and HC wavelength-1 arms of this study.
The Pittsburgh Sleep Quality Index (PSQI) subscale measurement that was used is overall sleep quality, which is derived from question 6 on the assessment and uses a Likert scale of 0 to 3. A score of 0 represents "very good" sleep quality (better outcome), while a measurement of 3 represents "very bad" sleep quality (worse outcome).
Outcome measures
| Measure |
mTBI Wavelength-2 Bright Light
n=18 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
mTBI Wavelength-1 Bright Light
n=17 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
|---|---|---|
|
Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)
|
1.28 score on a scale
Standard Deviation .67
|
1.35 score on a scale
Standard Deviation .7
|
PRIMARY outcome
Timeframe: Post 6-week interventionPopulation: Actigraphy data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
Sleep Efficiency is the overall percentage of time that the participant was scored as sleeping during their night of sleep (range: 0-100%). Higher percentages suggest higher sleep quality and a better outcome.
Outcome measures
| Measure |
mTBI Wavelength-2 Bright Light
n=18 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
mTBI Wavelength-1 Bright Light
n=17 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
|---|---|---|
|
Sleep Quality - Actigraphy Sleep Efficiency
|
82.57 percentage of time asleep
Standard Deviation 4.2
|
83.43 percentage of time asleep
Standard Deviation 5.11
|
PRIMARY outcome
Timeframe: Post 6-week interventionPopulation: Actigraphy data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
Wake After Sleep Onset (WASO) is how many minutes the participant, during their night of sleep, was determined to be awake after their sleep onset. Sleep onset is defined as a state of at least 2 minutes of uninterrupted sleep. Higher values indicate a worse outcome (range: 1-125 minutes).
Outcome measures
| Measure |
mTBI Wavelength-2 Bright Light
n=18 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
mTBI Wavelength-1 Bright Light
n=17 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
|---|---|---|
|
Sleep Quality - Actigraphy Wake After Sleep Onset
|
11.66 minutes
Standard Deviation 2.91
|
10.4 minutes
Standard Deviation 3.32
|
PRIMARY outcome
Timeframe: Post 6-week interventionPopulation: Data was collected for this measure but was unable to be analyzed due to issues extracting the data from the computer it was stored on. In addition, MSIT data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study 6-weeks after the inital visit.
Neural activation during functional magnetic resonance imaging (fMRI) measuring executive functioning using the MSIT.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Post 6-week interventionPopulation: ANAM data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
The Automated Neuropsychological Assessment Metrics (ANAM) is a neuropsychological battery that uses individual tests to measure cognitive efficiency in areas including attention, concentration, reaction time, memory, processing speed, and decision making. Subscale scores are put in terms of a throughput score, which is calculated to be a ratio of correct responses per minute, as a way to measure cognitive efficiency in the participant; as such, the units for the throughput scores would be in terms of correct responses/minute. Higher throughput scores indicate increased levels of cognitive efficiency in the relevant subscale. The throughput score ranges for the ANAM subscales are: code substitution learning: 0-147 responses per minute procedural reaction time: 0-151 responses per minute mathematical processing: 0-145 responses per minute matching to sample: 0-97 responses per minute code substitution delayed: 0-155 responses per minute
Outcome measures
| Measure |
mTBI Wavelength-2 Bright Light
n=18 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
mTBI Wavelength-1 Bright Light
n=17 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
|---|---|---|
|
Performance on Neuropsychological Assessment - Automated Neuropsychological Assessment Metrics
ANAM Code substitution learning -thruput score
|
51.3 correct responses/minute
Standard Deviation 15.8
|
60.3 correct responses/minute
Standard Deviation 10.8
|
|
Performance on Neuropsychological Assessment - Automated Neuropsychological Assessment Metrics
ANAM Procedural Reaction Time - thruput score
|
89.8 correct responses/minute
Standard Deviation 19.5
|
101.3 correct responses/minute
Standard Deviation 17.9
|
|
Performance on Neuropsychological Assessment - Automated Neuropsychological Assessment Metrics
ANAM Mathematical Processing - thruput score
|
18 correct responses/minute
Standard Deviation 8.5
|
22.1 correct responses/minute
Standard Deviation 8.2
|
|
Performance on Neuropsychological Assessment - Automated Neuropsychological Assessment Metrics
ANAM Matching to Sample - thruput score
|
30.5 correct responses/minute
Standard Deviation 10.1
|
33 correct responses/minute
Standard Deviation 12.2
|
|
Performance on Neuropsychological Assessment - Automated Neuropsychological Assessment Metrics
ANAM Code substitution delay-thruput score
|
43.3 correct responses/minute
Standard Deviation 14.2
|
56.2 correct responses/minute
Standard Deviation 8.9
|
PRIMARY outcome
Timeframe: Post 6-week interventionPopulation: RBANs data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) uses all of its subscales to calculate the RBANS total score (index). To obtain the RBANS total score (index), the raw scores of the subtests must first be computed into index scores for their relevant subscale (different subtest raw scores feed into specific subscales) using RBANS specific tables that have scaled scores embedded and are normed for the age of the participant. The index scores of each subscale are then summed together to get the Sum of Index Scores, which has a possible range of 200-800. Once the Sum of Index Scores is found, the total score (index) is then found using another RBANS specific table with scaled scores embedded within it. The total score (index) has a possible range of 40-160, with a higher total score (index) is related to a better outcome.
Outcome measures
| Measure |
mTBI Wavelength-2 Bright Light
n=18 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
mTBI Wavelength-1 Bright Light
n=17 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
|---|---|---|
|
Performance on Neuropsychological Assessment - Repeatable Battery for the Assessment of Neuropsychological Status
|
88.5 units on a scale
Standard Deviation 10.7
|
97.6 units on a scale
Standard Deviation 12.2
|
PRIMARY outcome
Timeframe: Post 6-week interventionPopulation: PVT data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study 6-weeks after the initial visit.
The Psychomotor Vigilance Task (PVT) is a task that tests alertness by having the participant press a button every time they see a stimulus image appear on a screen. This image is presented at random 2-10 second intervals throughout the entirety of the task. The reaction time (RT) is one of the PVT measurements and is the time, measured in milliseconds, that it takes for the participant to view the stimulus image and then press the button, confirming that they have indeed viewed the stimulus image at that time. The PVT measures speed using the following equation: 1/RT \* 1000. The PVT measurement used here is average speed, so all the calculated speeds were then averaged over the entire trial period to obtain the final value for that trial at that time point (post-tx 1,2,3). Since the PVT is a timed measurement of reaction times, lower scores are considered 'better' or indicate an increased level of vigilance.
Outcome measures
| Measure |
mTBI Wavelength-2 Bright Light
n=18 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
mTBI Wavelength-1 Bright Light
n=17 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
|---|---|---|
|
Performance on Neuropsychological Assessment - Psychomotor Vigilance Task
PVT average speed - Run 3 - post-tx
|
3.3 responses/minute
Standard Deviation 0.6
|
3.4 responses/minute
Standard Deviation 0.5
|
|
Performance on Neuropsychological Assessment - Psychomotor Vigilance Task
PVT average speed - Run 1 - post-tx
|
3.3 responses/minute
Standard Deviation 0.4
|
3.4 responses/minute
Standard Deviation 0.3
|
|
Performance on Neuropsychological Assessment - Psychomotor Vigilance Task
PVT average speed - Run 2 - post-tx
|
3.3 responses/minute
Standard Deviation 0.7
|
3.4 responses/minute
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Post 6-week interventionPopulation: ESS data was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
The Epworth Sleepiness Scale (ESS) is an 8-item questionnaire that characterizes the likelihood of the participant 'dozing off' during typical daily activities over their last 2 weeks, and uses a 0-3 point Likert scale, where 0 corresponds to "Would never doze" and 3 corresponds to having a "High chance of dozing" during the activity in question. The ESS score is calculated by adding up all the scores for each question, which means that the ESS score has a range of 0-24, while a higher score indicates that the participant had more issues with daytime sleepiness (worse outcome).
Outcome measures
| Measure |
mTBI Wavelength-2 Bright Light
n=18 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
mTBI Wavelength-1 Bright Light
n=17 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
|---|---|---|
|
Daytime Sleepiness - Epworth Sleepiness Scale
|
9.33 units on a scale
Standard Deviation 3.74
|
6.82 units on a scale
Standard Deviation 3.11
|
PRIMARY outcome
Timeframe: Post 6-week interventionPopulation: FOSQ was not collected for the HC wavelength-2 and HC wavelength-1 arms of this study.
The Functional Outcome of Sleep Questionnaire (FOSQ) questions 1-26 use a 1-4 (ordinal) likert (1 = "No difficulty" with sleepiness, 4 = "Yes, extreme difficulty" with sleepiness) and the participant also has the option of putting 0 = "I don't do this activity for other reasons". FOSQ questions 27-30 use a 1-4 Likert scale where 1 = "Very low" in terms of characterizing the level that sleepiness affects different aspects of their intimate romantic relations, while a 4 = "High" amount of impact on their intimate romantic relations. The FOSQ total score measurement is determined by calculating the mean of all 5 subscale scores and then multiplying that value by 5 (range: 0-24). A higher score indicates that the participant had more issues with daytime sleepiness.
Outcome measures
| Measure |
mTBI Wavelength-2 Bright Light
n=18 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
mTBI Wavelength-1 Bright Light
n=17 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
|---|---|---|
|
Daytime Sleepiness - Functional Outcome of Sleep Questionnaire
|
16.28 units on a scale
Standard Deviation 1.88
|
17.33 units on a scale
Standard Deviation 2.39
|
PRIMARY outcome
Timeframe: Post 6-week interventionPopulation: The RPCSQ was not administered to the HC wavelength-2 and HC wavelength-1 arms of this study.
The Rivermead Post-Concussion Symptoms Questionnaire (RPCSQ) will be used to assess post-concussive symptoms related to sleep. All questions on the RPCSQ use a 0 to 4 Likert scale concerning the severity of experiencing differing symptoms, where 0 = "not experienced" and 4 = "severe problem". As such, having a higher score is indicative that the participant is having more serious sleep issues related to their head injury. The RPCSQ subscale measurements that were used below are: RPQ3, which is the summed scores from the first 3 questions on the form, with the subscale total ranging from 0-12, and RPQ13, which is the summed scores from questions 4 to 16 on the form, with the subscale total ranging from 0-52. The RPQ3 subscale is associated with earlier symptom clusters of post-concussive symptoms as they relate to sleep disturbances, while the RPQ13 subscale is associated with later symptom clusters of post-concussive symptoms as they relate to sleep disturbances.
Outcome measures
| Measure |
mTBI Wavelength-2 Bright Light
n=18 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
mTBI Wavelength-1 Bright Light
n=17 Participants
30 minutes daily light exposure for 6 weeks
mTBI wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning
|
|---|---|---|
|
Post-Concussive Symptoms (Rivermead Post-Concussion Symptoms Questionnaire)
RPQ3
|
3 score on a scale
Standard Deviation 2.4
|
2.7 score on a scale
Standard Deviation 2.7
|
|
Post-Concussive Symptoms (Rivermead Post-Concussion Symptoms Questionnaire)
RPQ13
|
12.8 score on a scale
Standard Deviation 11.1
|
11.1 score on a scale
Standard Deviation 8.3
|
Adverse Events
mTBI Wavelength-1 Bright Light
mTBI Wavelength-2 Bright Light
HC Wavelength-1 Bright Light
HC 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