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Bright Light Therapy for TBI (SPTBI Trial)

N/A

Waitlist Available

Led By Jonathan E Elliott, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate to severe pain persisting for longer than 6 months

Be older than 18 years old

Must not have

History of macular degeneration and/or bipolar disorder

Cancer diagnosis within the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre- and post-4 weeks of mblt or sham treatment, and 12 weeks following the end of mblt or sham treatment

Summary

This trial aims to improve sleep quality for veterans with TBI as a means to reduce pain and improve quality of life and functional outcome measures. The investigators predict that the proposed intervention, morning bright light therapy, if found effective, will be rapidly deployable and highly accepted by Veterans with TBI.

Who is the study for?

This trial is for Veterans with a confirmed diagnosis of mild TBI who are experiencing sleep disturbances and have had moderate to severe pain for over 6 months. Participants must speak English and have phone access. It excludes those with decisional impairment, dementia, current light therapy use, shift workers, certain medical conditions like macular degeneration or bipolar disorder, recent surgery or cancer treatment, and recent substance abuse.

What is being tested?

The study tests whether morning bright light therapy can improve sleep quality in Veterans with TBI compared to the use of a negative ion generator. The goal is to see if better sleep helps reduce pain and enhances overall quality of life and functional outcomes.

What are the potential side effects?

Potential side effects from morning bright light therapy may include eyestrain, headache, nausea, irritability or agitation. Negative ion generators are generally considered safe but could cause respiratory discomfort in some individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had moderate to severe pain for more than 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of macular degeneration or bipolar disorder.

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I was diagnosed with cancer in the last 6 months.

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I have been diagnosed with decisional impairment or dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre- and post-4 weeks of mblt or sham treatment, and 12 weeks following the end of mblt or sham treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre- and post-4 weeks of mblt or sham treatment, and 12 weeks following the end of mblt or sham treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre- and post-4 weeks of mblt or sham treatment, and 12 weeks following the end of mblt or sham treatment for reporting.