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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
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

SPTBI Trial 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.Check my eligibility
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.See study design
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.

SPTBI Trial 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.

SPTBI Trial 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

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

SPTBI 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
1,609 Previous Clinical Trials
3,306,329 Total Patients Enrolled
Jonathan E Elliott, PhDPrincipal InvestigatorVA Portland Health Care System, Portland, OR

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant count of this clinical research?

"Affirmative. Clinicaltrials.gov data suggests that this clinical trial, which was initially posted on November 1st 2019, is actively enrolling participants. The study requires 100 patients from one medical centre to fully participate."

Answered by AI

Is there still room for additional participants in this clinical experiment?

"According to the medical information accessible on clinicaltrials.gov, this study is actively recruiting patients; it was first advertised in November of 2019 and revised as recently as January 13th 2022."

Answered by AI

Is the age limit for enrollment in this study restricted to those under 40 years of age?

"The criteria for enrollment in this trial specify that prospective participants must be of legal age and 70 years old or younger."

Answered by AI

Am I able to join the research initiative?

"To join this research, prospective participants need to have suffered a brain injury and be within the 18-70 age bracket. At present, roughly 100 individuals are being accepted into the trial."

Answered by AI

Who else is applying?

What state do they live in?
Oregon
How old are they?
18 - 65
What site did they apply to?
VA Portland Health Care System, Portland, OR
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Improving Sleep in Veterans With TBI
2019. "Improving Sleep in Veterans With TBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03785600.
All > Tb > Traumatic Brain Injury
~2 spots leftby May 2024
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