← Back to Search

Bright Light Therapy for TBI (SPTBI Trial)

N/A
Recruiting
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
Awards & highlights

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
Select...
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:
Select...
I have a history of macular degeneration or bipolar disorder.
Select...
I was diagnosed with cancer in the last 6 months.
Select...
I have been diagnosed with decisional impairment or dementia.

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
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.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
self-reported pain change determined via the NIH PROMIS scale

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Morning Bright Light TherapyExperimental Treatment1 Intervention
Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
Group II: Negative Ion GeneratorPlacebo Group1 Intervention
Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,970 Total Patients Enrolled
Jonathan E Elliott, PhDPrincipal InvestigatorVA Portland Health Care System, Portland, OR
1 Previous Clinical Trials
138 Total Patients Enrolled

Media Library

Morning Bright Light Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03785600 — N/A
Traumatic Brain Injury Research Study Groups: Morning Bright Light Therapy, Negative Ion Generator
Traumatic Brain Injury Clinical Trial 2023: Morning Bright Light Therapy Highlights & Side Effects. Trial Name: NCT03785600 — N/A
Morning Bright Light Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03785600 — N/A
~17 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top