N/A
N=77
Bright Light Therapy for Treatment of Sleep Problems Following Mild Traumatic Brain Injury
Concussion, Mild · Post-Concussion Symptoms · Sleep Problems
Bottom Line
View on ClinicalTrials.gov: NCT02374918 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Sleep Quality - Pittsburgh Sleep Quality Index (PSQI) — 1.28; 1.35 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mTBI wavelength-1 bright light (Device); mTBI wavelength-2 bright light (Device); HC wavelength-1 bright light (Device); HC wavelength-2 bright light (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arizona
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Quality - Pittsburgh Sleep Quality Index (PSQI) |
1.28; 1.35 | — |
| PRIMARY Sleep Quality - Actigraphy Sleep Efficiency |
82.57; 83.43 | — |
| PRIMARY Sleep Quality - Actigraphy Wake After Sleep Onset |
11.66; 10.4 | — |
| PRIMARY Executive Function Task - Multi-Source Interference Task (MSIT) |
— | — |
| PRIMARY Performance on Neuropsychological Assessment - Automated Neuropsychological Assessment Metrics |
51.3; 60.3; 89.8; 101.3; 18; 22.1 | — |
| PRIMARY Performance on Neuropsychological Assessment - Repeatable Battery for the Assessment of Neuropsychological Status |
88.5; 97.6 | — |
| PRIMARY Performance on Neuropsychological Assessment - Psychomotor Vigilance Task |
3.3; 3.4; 3.3; 3.4; 3.3; 3.4 | — |
| PRIMARY Daytime Sleepiness - Epworth Sleepiness Scale |
9.33; 6.82 | — |
| PRIMARY Daytime Sleepiness - Functional Outcome of Sleep Questionnaire |
16.28; 17.33 | — |
| PRIMARY Post-Concussive Symptoms (Rivermead Post-Concussion Symptoms Questionnaire) |
3; 2.7; 12.8; 11.1 | — |
Summary
The purpose of the research study is to understand the effectiveness of a six-week course of light exposure on cognitive functioning, mood, activity, and sleep in people that have suffered a head injury leading to a concussion.
Eligibility Criteria
Inclusion criteria
- Age range between 18 and 50.
- The primary language of the subjects must be English.
- Subjects have experienced a "concussion" or mTBI within the preceding 18 months, but no sooner that 4 weeks prior to their screening. The occurrence of a concussion or mTBI must be documented by a medical report or other professional witness documentation.
- If documented, Glasgow Coma Scale in the range of 13-15 following the injury.
- Subjects must have complaints of sleep difficulties that emerged or worsened following the most recent head injury.
- At least half of subjects must have evidence of sleep onset insomnia or delayed sleep phase disorder.
Exclusion criteria
- Any other history of neurological illness, current Diagnostic Statistical Manual (DSM-IV) Axis I disorder, lifetime history of psychotic disorder, or head injury with loss of consciousness > 30 minutes
- Complicating medical conditions that may influence the outcome of neuropsychological assessment or functional imaging (e.g., HIV, brain tumor, etc.)
- Abnormal visual acuity that is not corrected by contact lenses
- Metal within the body, claustrophobia, or other contraindications for neuroimaging
- Less than 9th grade education
- Excess current alcohol use (more than 2 instances of intake of 5+ drinks (men) when or 4+ drinks (women) when drinking in the past two months, and/or on average drinking > 2 drinks per day (men); > 1 drinks per day (women) during the past two months
- History of alcoholism or substance use disorder
- Significant use of illicit drugs
- History of marijuana use within the past 6 weeks and/or use of marijuana before the age of 16.
Subjects who engage in shift-work, night work, or who have substantially desynchronized work-sleep schedules (i.e., sleeping later than 10:00 a.m. more than once a week) will be excluded.
Data sourced from ClinicalTrials.gov (NCT02374918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.