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Bright Light Therapy for Treatment of Sleep Problems Following Mild Traumatic Brain Injury

This study is currently recruiting participants.
Verified May 2017 by William D. Killgore, University of Arizona
Sponsor:
ClinicalTrials.gov Identifier:
NCT02374918
First Posted: March 2, 2015
Last Update Posted: May 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
U.S. Army Medical Research Acquisition Activity
Information provided by (Responsible Party):
William D. Killgore, University of Arizona
  Purpose

Mild traumatic brain injuries (mTBI) or "concussions" are an increasingly prevalent injury in the investigators society. Patients with post-concussion syndrome have been shown to have deficits on tests of short term memory, divided attention, multi-tasking, information processing speed, and reaction time, as well as alteration in mood and emotional functioning. Many patients have other vague complaints including fatigue, dizziness, irritability, sleep disturbances, and chronic headaches. Furthermore, sleep disruption of one of the most common complaints in patients suffering from traumatic brain injuries, with as many as 40 to 65% of patients with mTBI complaining of insomnia. Sleep problems in these patients are associated with poorer outcome, while resolution of the sleep disturbance is associated with improvement in cognitive functioning.

Despite recent evidence of the correlation between sleep quality and recovery from traumatic brain injury, and the well-established role of sleep in neural plasticity and neurogenesis, there have been virtually no direct studies of the causal effects of sleep on recovery following mTBI. However, it is quite likely that sleep plays a critical role in recovery following brain injury.

A particularly promising non-pharmacologic approach that shows potential in improving/modifying abnormalities of the circadian rhythm and sleep-wake schedule is bright light therapy. For the proposed investigation, the investigators hypothesize that bright light therapy may be helpful in improving the sleep of patients with a recent history of mTBI and may also have other mood elevating effects, both of which should promote positive treatment outcome in these individuals. Bright light therapy may increase the likelihood that they will recover more quickly, benefit more extensively from other forms of therapy, and build emotional and cognitive resilience.

This study will also have a healthy control (HC)/effect localization arm that will assist in identifying and mapping the brain systems before and after light exposure so that researchers may develop further insights into the relationship between concussion, light exposure, sleep, and brain function. This healthy control arm will also provide brain targets for study in the analysis of the Main Study Arm.


Condition Intervention
Concussion, Mild Post-Concussion Symptoms Sleep Problems Device: mTBI wavelength-1 bright light Device: mTBI wavelength-2 bright light Device: HC wavelength-1 bright light Device: HC wavelength-2 bright light

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bright Light Therapy for Treatment of Sleep Problems Following Mild Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by William D. Killgore, University of Arizona:

Primary Outcome Measures:
  • Sleep Quality ( self-report measure: Pittsburgh Sleep Quality Index, and an objective measure: Actigraphy will be used to assess sleep quality) [ Time Frame: Change from baseline at 6 weeks (post-treatment) and 12 weeks (follow-up) ]
    A self-report measure: Pittsburgh Sleep Quality Index, and an objective measure: Actigraphy will be used to assess sleep quality.

  • Neural activation during functional magnetic resonance imaging (fMRI) executive function task (Multi-Source Interference Task (MSIT) [ Time Frame: Change from baseline performance at 6 weeks (post-treatment) ]
    fMRI Task measuring executive functioning: Multi-Source Interference Task (MSIT)

  • Performance on neuropsychological assessment (Automated Neuropsychological Assessment Metrics, Repeatable Battery for the Assessment of Neuropsychological Status, and Psychomotor Vigilance Task will be used to assess this.) [ Time Frame: Change from baseline performance at 6 weeks (post-treatment) ]
    Automated Neuropsychological Assessment Metrics, Repeatable Battery for the Assessment of Neuropsychological Status, and Psychomotor Vigilance Task will be used to assess this.

  • Post-Concussive Symptoms (Rivermead Post-Concussion Symptoms Questionnaire) [ Time Frame: Change from baseline performance at 6 weeks (post-treatment) ]
    The Rivermead Post-Concussion Symptoms Questionnaire will be used to assess post-concussive symptoms.

  • Daytime Sleepiness ( Stanford Sleepiness Scale, Epworth Sleepiness Scale, Functional Outcome of Sleep Questionnaire, and an Objective Measure: Multiple Sleep Latency Test will be used to assess daytime sleepiness) [ Time Frame: Change from baseline performance at 6 weeks (post-treatment) ]
    Self-Report measures: Stanford Sleepiness Scale, Epworth Sleepiness Scale, Functional Outcome of Sleep Questionnaire, and an Objective Measure: Multiple Sleep Latency Test will be used to assess daytime sleepiness.


Estimated Enrollment: 69
Study Start Date: April 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mTBI wavelength-1 bright light
30 minutes daily light exposure for 6 weeks
Device: mTBI wavelength-1 bright light
6 weeks of daily light exposure, 30 minutes per morning
Placebo Comparator: mTBI wavelength-2 bright light
30 minutes daily light exposure for 6 weeks
Device: mTBI wavelength-2 bright light
6 weeks of daily light exposure, 30 minutes per morning
Experimental: HC wavelength-1 bright light
30 minutes of light exposure
Device: HC wavelength-1 bright light
30 minutes of light exposure
Placebo Comparator: HC wavelength-2 bright light
30 minutes of light exposure
Device: HC wavelength-2 bright light
30 minutes of light exposure

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Age range between 18 and 50.
  • Subjects must be right handed.
  • 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.)
  • Mixed or left-handedness
  • 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, use of marijuana before the age of 16, and/or use of > 20 marijuana cigarettes throughout the participant's lifetime.

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374918


Contacts
Contact: Melissa Millan mmillan@psychiatry.arizona.edu
Contact: Anmol Singh anmolsingh@psychiatry.arizona.edu

Locations
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Melissa Millan       mmillan@psychiatry.arizona.edu   
Contact: Anmol Singh       anmolsingh@psychiatry.arizona.edu   
Principal Investigator: William D Killgore, Ph.D.         
Sponsors and Collaborators
University of Arizona
U.S. Army Medical Research Acquisition Activity
Investigators
Principal Investigator: William D Killgore, Ph.D. University of Arizona
  More Information

Responsible Party: William D. Killgore, Principal Investigator, University of Arizona
ClinicalTrials.gov Identifier: NCT02374918     History of Changes
Other Study ID Numbers: 1404301151
First Submitted: October 15, 2014
First Posted: March 2, 2015
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by William D. Killgore, University of Arizona:
Mild traumatic brain injury
Concussion
Sleep problems
Brain imaging
fMRI

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Dyssomnias
Sleep Wake Disorders
Parasomnias
Post-Concussion Syndrome
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating
Mental Disorders
Neurologic Manifestations
Signs and Symptoms