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Bright Light Therapy for Frailty in Older Veterans (Brite-VET Trial)
N/A
Recruiting
Led By Bruce R. Troen, MD
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
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to endpoint at 12 weeks
Summary
This trial will study whether bright light therapy can reduce frailty, improve sleep & cognitive function in older Veterans.
Who is the study for?
This trial is for older veterans who may be frail and have early-stage health issues. It's open to both men and women living in the community, but not those who are very overweight, without sleep problems, or with severe illnesses or cognitive impairments.
What is being tested?
The study tests Bright Light Therapy using AYO Glasses to see if they can help reduce frailty and improve cognition and sleep quality in elderly veterans by resynchronizing their biological clocks.
What are the potential side effects?
Bright Light Therapy is generally safe but could potentially cause eye strain or headache. Since it involves light exposure, there might also be a risk of disrupted sleep patterns if used improperly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to endpoint at 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to endpoint at 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Amyloid beta 42/40 ratio
Anxiety and depression
Brain Derived Neurotrophic Factor (BDNF)
+16 moreSecondary study objectives
Body Composition (Lean and fat mass)
Frailty assessment
Gait speed
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: BLT interventionActive Control1 Intervention
Bright light glasses that emit a more intense therapeutic blue light.
Group II: BLT controlPlacebo Group1 Intervention
Bright light glasses that emit a non-therapeutic blue light.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,663 Previous Clinical Trials
3,427,253 Total Patients Enrolled
Bruce R. Troen, MDPrincipal InvestigatorKansas City VA Medical Center, Kansas City, MO
2 Previous Clinical Trials
242 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a community dweller, either male or female.My BMI is over 40.I have severe health problems or trouble thinking clearly.I am generally healthy, possibly with minor health issues.
Research Study Groups:
This trial has the following groups:- Group 1: BLT control
- Group 2: BLT intervention
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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