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Effects of Bright Light Therapy in Mild Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT01747811
Recruitment Status : Completed
First Posted : December 12, 2012
Results First Posted : August 15, 2016
Last Update Posted : June 1, 2017
Sponsor:
Collaborator:
U.S. Army Medical Research Acquisition Activity
Information provided by (Responsible Party):
William D. Killgore, University of Arizona

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Concussion, Mild
Post-Concussion Symptoms
Sleep Problems
Interventions Device: wavelength-1 bright light
Device: wavelength-2 bright light
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Wavelength-1 Bright Light Wavelength-2 Bright Light
Hide Arm/Group Description 30 minutes daily light exposure for 6 weeks 30 minutes daily light exposure for 6 weeks
Period Title: Overall Study
Started 16 16
Completed 14 12
Not Completed 2 4
Reason Not Completed
Lack of Efficacy             2             4
Arm/Group Title Wavelength-1 Bright Light Wavelength-2 Bright Light Total
Hide Arm/Group Description

30 minutes daily light exposure for 6 weeks

wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning

30 minutes daily light exposure for 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 14 12 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 26 participants
<=18 years
0
   0.0%
2
  16.7%
2
   7.7%
Between 18 and 65 years
14
 100.0%
10
  83.3%
24
  92.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 12 participants 26 participants
23.07  (7.50) 23.46  (8.64) 23.24  (7.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 26 participants
Female
9
  64.3%
6
  50.0%
15
  57.7%
Male
5
  35.7%
6
  50.0%
11
  42.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 12 participants 26 participants
14 12 26
1.Primary Outcome
Title Performance on Multiple Sleep Latency Test (MSLT)
Hide Description 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.
Time Frame Change from baseline performance at 6 weeks (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wavelength-1 Bright Light Wavelength-2 Bright Light
Hide Arm/Group Description:

30 minutes daily light exposure for 6 weeks

wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning

30 minutes daily light exposure for 6 weeks
Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: minutes
MSLT_PreTreatment_Sleep Onset Latency (SOL) 6.67  (3.91) 7.32  (5.41)
MSLT_PostTreatment_Sleep Onset Latency (SOL) 6.73  (5.98) 7.88  (5.83)
2.Secondary Outcome
Title Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Executive Function Task
Hide Description 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.
Time Frame Change from baseline performance at 6 weeks (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 22 participants had useable data, 4 participants were excluded due to movement in the images.
Arm/Group Title Wavelength-1 Bright Light Wavelength-2 Bright Light
Hide Arm/Group Description:

30 minutes daily light exposure for 6 weeks

wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning

30 minutes daily light exposure for 6 weeks

wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning

Overall Number of Participants Analyzed 13 9
Mean (Standard Deviation)
Unit of Measure: Percent Signal Change
0.098  (0.106) -0.025  (0.25)
3.Secondary Outcome
Title Score on Pittsburgh Sleep Quality Index (PSQI)
Hide Description 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.
Time Frame Change from baseline at 6 weeks (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wavelength-1 Bright Light Wavelength-2 Bright Light
Hide Arm/Group Description:
30 minutes daily light exposure for 6 weeks
30 minutes daily light exposure for 6 weeks
Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pittsburgh Sleep Quality Index_Mean_PreTreatment 6.50  (2.14) 8.25  (1.60)
Pittsburgh Sleep Quality Index_Mean_PostTreatment 4.79  (2.29) 6.25  (3.19)
4.Secondary Outcome
Title Actigraphy-measured Sleep Quality
Hide Description 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).
Time Frame Change from baseline at 6 weeks (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
We collected usable actigraphy from 29 participants. The 7 remaining participants had unusable actigraphy data.
Arm/Group Title Wavelength-1 Bright Light Wavelength-2 Bright Light
Hide Arm/Group Description:

30 minutes daily light exposure for 6 weeks

wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning

30 minutes daily light exposure for 6 weeks

wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning

Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: minutes
86.17  (1.60) 85.70  (5.21)
5.Secondary Outcome
Title Performance on Neuropsychological Assessment
Hide Description 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.
Time Frame Change from baseline at 6 weeks (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wavelength-1 Bright Light Wavelength-2 Bright Light
Hide Arm/Group Description:

30 minutes daily light exposure for 6 weeks

wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning

30 minutes daily light exposure for 6 weeks
Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment 102.71  (9.55) 101.67  (19.01)
Post Treatment 98.50  (9.20) 95.33  (15.39)
6.Other Pre-specified Outcome
Title Change From Baseline in Beck Depression Inventory (BDI-II) Scores at 6 Weeks
Hide Description 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.
Time Frame Change from baseline at 6 weeks (post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wavelength-1 Bright Light Wavelength-2 Bright Light
Hide Arm/Group Description:
30 minutes daily light exposure for 6 weeks
30 minutes daily light exposure for 6 weeks
Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.00  (5.07) 4.83  (3.88)
Time Frame [Not Specified]
Adverse Event Reporting Description No serious or adverse events occurred during the course of the study.
 
Arm/Group Title Wavelength-1 Bright Light Wavelength-2 Bright Light
Hide Arm/Group Description 30 minutes daily light exposure for 6 weeks 30 minutes daily light exposure for 6 weeks
All-Cause Mortality
Wavelength-1 Bright Light Wavelength-2 Bright Light
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Wavelength-1 Bright Light Wavelength-2 Bright Light
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Wavelength-1 Bright Light Wavelength-2 Bright Light
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: William Killgore
Organization: University of Arizona
Phone: 520-621-0605
EMail: killgore@psychiatry.arizona.edu
Layout table for additonal information
Responsible Party: William D. Killgore, University of Arizona
ClinicalTrials.gov Identifier: NCT01747811     History of Changes
Other Study ID Numbers: 2010-P-001570/1
First Submitted: December 6, 2012
First Posted: December 12, 2012
Results First Submitted: November 30, 2015
Results First Posted: August 15, 2016
Last Update Posted: June 1, 2017