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Behavioural Intervention
Bright Light Therapy for PTSD (LIONv2 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
Current self-reported sleep disturbances
Be older than 18 years old
Must not have
History of macular degeneration and/or bipolar disorder
Significant impairing post-stroke residual hemiparesis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre- and post-4 weeks of mblt or sham treatment
Summary
This trial aims to help veterans experiencing a combination of traumatic brain injury, post-traumatic stress disorder, and chronic pain, known as the "polytrauma clinical triad". The researchers believe that sleep
Who is the study for?
This trial is for veterans with the 'polytrauma clinical triad'—a combination of traumatic brain injury, post-traumatic stress disorder (PTSD), and chronic pain. Participants should be experiencing sleep disturbances and cognitive impairment related to these conditions.
What is being tested?
The study tests morning bright light therapy as a home-based treatment aimed at improving sleep quality in order to alleviate symptoms associated with the polytrauma clinical triad and enhance overall quality of life for veterans.
What are the potential side effects?
While not explicitly stated, side effects may include discomfort or eye strain from bright light therapy, but generally, this type of intervention is considered low-risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently experiencing problems with my sleep.
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 have significant weakness on one side of my body after a stroke.
Select...
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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre- and post-4 weeks of mblt or sham treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Sleep Efficiency via wrist based actigraphy
Secondary study objectives
Self-reported sleep quality via the Pittsburgh Sleep Quality Index
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 120 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 120 minutes of waking up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Morning Bright Light Therapy
2019
N/A
~100
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,770 Total Patients Enrolled
42 Trials studying Chronic Pain
5,076 Patients Enrolled for Chronic Pain
Jonathan E Elliott, PhDPrincipal InvestigatorVA Portland Health Care System, Portland, OR
1 Previous Clinical Trials
100 Total Patients Enrolled