Bright Light Therapy for Frailty in Older Veterans

(Brite-VET Trial)

Overseen By Bruce R Troen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: No sleep disturbances, Morbid obesity, Severe comorbidities, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether bright light therapy (BLT) can reduce frailty, improve sleep, and boost brain function in older Veterans. Participants will wear special glasses, known as AYO Glasses, which emit either a calming or a more powerful therapeutic blue light. The goal is to determine if this simple home treatment can enhance the overall health and well-being of Veterans. The trial seeks relatively healthy older Veterans who experience sleep problems and may have early-stage health issues. As an unphased trial, it offers Veterans the opportunity to contribute to innovative research that could improve their health and quality of life.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that bright light therapy is safe for older Veterans?

Research shows that bright light therapy (BLT) using AYO glasses is generally safe. These glasses emit blue light without harmful UV or infrared rays, ensuring eye safety. They meet international safety standards and have been independently certified by TÜV Rheinland, a global testing service.

Previous studies selected AYO devices to address safety concerns, and participants in those trials reported no major side effects, suggesting the treatment is well-tolerated. Although this trial focuses on older veterans, existing safety data reassures the use of the treatment in this group. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of AYO Glasses for frailty in older veterans because they offer a novel approach using bright light therapy. Unlike traditional treatments for frailty, which often rely on physical exercise and nutritional supplements, AYO Glasses use therapeutic blue light to potentially improve physical and cognitive functions. The glasses are unique because they deliver this light directly to the eyes, which may help regulate circadian rhythms and boost mood and energy levels. This non-invasive method could provide a practical and innovative option, especially for individuals who may have difficulty engaging in traditional therapies.

What evidence suggests that bright light therapy is effective for frailty?

Research shows that bright light therapy (BLT) can help older adults sleep better and think more clearly by resetting the body's internal clock, which manages sleep and alertness. Although BLT hasn't been specifically tested for frailty in older Veterans, its positive effects on sleep and cognition suggest potential benefits. In this trial, participants will join one of two groups: the BLT intervention group, using bright light glasses that emit a more intense therapeutic blue light, or the BLT control group, using glasses that emit a non-therapeutic blue light. Studies have found that bright light can reduce tiredness, often linked to frailty. While more research is needed for this specific group, early signs suggest BLT could enhance overall health and strength in older people. ^{1 2 3 4 6}

Who Is on the Research Team?

Bruce R. Troen, MD

Principal Investigator

Kansas City VA Medical Center, Kansas City, MO

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a community dweller, either male or female.

I am generally healthy, possibly with minor health issues.

Exclusion Criteria

Individuals without sleep disturbances (PSQI >5)

My BMI is over 40.

I have severe health problems or trouble thinking clearly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bright light therapy (BLT) to study impacts on frailty, cognition, and sleep

12 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AYO Glasses

Trial Overview 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.

How Is the Trial Designed?

Group I: BLT intervention Active Control 1 Intervention

Bright light glasses that emit a more intense therapeutic blue light.

Group II: BLT control Placebo Group 1 Intervention

Bright light glasses that emit a non-therapeutic blue light.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05631236

Promoting Cognitive Resilience and Reducing Frailty in ... This randomized trial will assess the feasibility of employing BLT to study impacts on frailty, cognition, and sleep in older Veterans.

2. withpower.com withpower.com/trial/phase-frailty-1-2023-c7f75

Bright Light Therapy for Frailty in Older Veterans (Brite-VET ... Trial Overview 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 ...

3. research.va.gov research.va.gov/about/funded_research/proj-details-FY2024.cfm?pid=752590

Promoting cognitive resilience and reducing frailty in older ... Promoting cognitive resilience and reducing frailty in older Veterans with bright light therapy. Principal Investigator: Bruce R. Troen. Location: Kansas City ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9608534/

Series of virtual light therapy interventions for fatigue Research shows that bright light and dim light therapy may be an efficacious way to reduce symptoms of fatigue. Still, the feasibility, ...

5. cet.org cet.org/ayo-circadian-light-therapy-glasses-scientific-studies/

AYO Circadian Light Therapy Glasses - Scientific Studies The AYO wearable light therapy device, has become a go-to solution and primary light intervention in numerous research studies.

6. goayo.com goayo.com/

AYO: World's Best Light Therapy Glasses UV and Infrared free, AYO is considered safe for the eyes in accordance with international standards and is independently certified by TÜV Rheinland. Natural ...