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

Completed · Not applicable

Conditions studied: Concussion, Mild, Post-Concussion Symptoms, Sleep Problems

In brief

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.

Key facts

Study ID

NCT02374918

Run by

University of Arizona

People needed

77

Starts

2014-12-01

Expected to finish

2019-12-01

Last updated by the study team

2021-06-24

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Arizona — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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