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Light Box Therapy for Traumatic Brain Injury

N/A
Recruiting
Led By Miranda Lim, MD, PhD
Research Sponsored by Portland VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; after 4 weeks of intervention; and 2 months after the end of intervention
Awards & highlights

Study Summary

This trial is testing whether morning bright light therapy can help improve sleep for veterans with traumatic brain injury. It will also explore whether this therapy can affect cognition, mood, and quality of life measures.

Who is the study for?
This trial is for Veterans who have experienced a traumatic brain injury. Participants must speak English and be reachable by phone. It's not suitable for those with decision-making impairments, bipolar disorder, current users of lightbox or negative ion generators, macular degeneration, or those doing shift work.Check my eligibility
What is being tested?
The study tests if morning bright light therapy (MBLT) can improve sleep quality in Veterans with TBI. It also explores how MBLT affects cognition, mood, life quality and examines blood markers to predict response to the treatment. The entire study can be done remotely.See study design
What are the potential side effects?
Potential side effects from MBLT may include eye strain or headache due to bright light exposure. Negative Ion Generator use might cause respiratory discomfort in some individuals but generally has minimal side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; after 4 weeks of intervention; and 2 months after the end of intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; after 4 weeks of intervention; and 2 months after the end of intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Insomnia Severity Index (ISI)
Secondary outcome measures
Change in NFL, GFAP, UCH-L1, and total tau

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Light boxExperimental Treatment1 Intervention
Commercially available lightbox emitting 10,000 lux of light. Subjects asked to use lightbox everyday for an hour for 4 weeks upon waking.
Group II: Negative Ion GeneratorPlacebo Group1 Intervention
Commercially available negative ion generator. Subjects asked to use everyday for an hour for 4 weeks upon waking.

Find a Location

Who is running the clinical trial?

Portland VA Medical CenterLead Sponsor
41 Previous Clinical Trials
7,042 Total Patients Enrolled
Center for Neuroscience and Regenerative Medicine (CNRM)FED
23 Previous Clinical Trials
5,067 Total Patients Enrolled
Miranda Lim, MD, PhDPrincipal InvestigatorPortland VA

Media Library

Light box therapy Clinical Trial Eligibility Overview. Trial Name: NCT03968874 — N/A
Traumatic Brain Injury Clinical Trial 2023: Light box therapy Highlights & Side Effects. Trial Name: NCT03968874 — N/A
Light box therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03968874 — N/A
Traumatic Brain Injury Research Study Groups: Light box, Negative Ion Generator

Frequently Asked Questions

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

Could I be a contender for this research endeavor?

"This clinical study seeks 300 people afflicted with brain injuries that are between 18 and 88 years of age. To qualify, it is imperative they can be reached via telephone."

Answered by AI

How many persons are participating in this medical research?

"Affirmative. Clinicaltrials.gov has published information indicating that recruitment for this clinical trial is ongoing, with the first post being dated August 1st 2019 and the last update on April 4th 2022. The study requires 300 participants from a single site."

Answered by AI

Is this experiment actively recruiting participants?

"Affirmative. Clinicaltrials.gov confirms that this experiment is actively recruiting, having been initially posted on August 1st 2019 and most recently updated on April 4th 2022. The trial requires the participation of 300 individuals from a single site."

Answered by AI

Are participants aged 25 years or older accepted for this research trial?

"The qualifications for participants of this clinical trial are that they must be between 18-88 years old. Seperate trials, 61 and 227 respectively, exist for those underage or elderly to the population in question."

Answered by AI
~15 spots leftby Aug 2024