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Promoting Cognitive Resilience and Reducing Frailty in Older Veterans With Bright Light Therapy (Brite-VET)

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VA Office of Research and Development

Status

Active, not recruiting

Conditions

Veteran Aged 65 and Older

Treatments

Device: Bright Light Therapy (AYO Glasses)

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT05631236
I21RX004420-01 (Other Grant/Funding Number)
E4420-P

Details and patient eligibility

About

Frailty is a multifactorial syndrome characterized by vulnerability to stressors that is intricately linked to cognitive impairment and mortality risk. Bright light therapy (BLT) reduces circadian disturbances by resynchronizing the hypothalamic biological clock via specific wavelengths of light. Human trials have demonstrated that BLT improves sleep quality and cognitive function in older adults. However, BLT has not been examined for use in older Veteran populations, particularly the impact on frailty. This randomized trial will assess the feasibility of employing BLT to study impacts on frailty, cognition, and sleep in older Veterans. Findings from this pilot will establish the power and effect size necessary for larger trials to support the use of BLT as readily available home-based treatment to improve healthspan of Veterans.

Full description

Promoting cognition and reducing frailty in older Veterans with bright light therapy Frailty is a multifactorial syndrome characterized by vulnerability to stressors that increases disability and mortality risk. Thirty percent of Veterans 65 years or older are frail, which is three-times higher than aged matched non-Veterans. Frailty is intricately linked with cognitive impairment and Veterans are particularly susceptible with 14 percent exhibiting cognitive decline, some with early onset as young as 45 years of age. Importantly, 70% of frail and cognitively impaired older adults exhibit sleep disturbances, which makes identifying and improving sleep quality an attractive therapeutic strategy to enhance healthspan. Furthermore, this is of special interest as 55% of older Veterans experience sleep disturbances. The goal of this study is to examine the feasibility of utilizing bright light therapy (BLT) as a strategy to improve sleep via reduction of circadian rhythm disturbances. The long-term goal is to assess the potential for improving cognition and reducing frailty in older Veterans. BLT works by resynchronizing the hypothalamic biological clock via brief exposure to specific wavelengths of light following awakening, which restores melatonin and circadian rhythms. However, BLT has not been examined for reducing frailty in older Veteran populations. This project will therefore lay the foundation for larger trials the evaluate BLT in the treatment and prevention of cognitive disorders and to promote healthy aging.

Enrollment

43 patients

Sex

All

Ages

60 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Participants studied in this project will include 30 men and 5 women of any race who are community dwellers
  • The investigators seek to recruit relatively healthy individuals that may or may not exhibit early-stage co-morbidities

Exclusion criteria

  • The investigators will exclude individuals without sleep disturbances (PSQI >5)
  • Are morbidly obese (BMI > 40)
  • Exhibit severe or advanced co-morbidities, or have cognitive impairment

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

43 participants in 2 patient groups, including a placebo group

BLT control
Placebo Comparator group
Description:
Bright light glasses that emit a non-therapeutic blue light.
Treatment:
Device: Bright Light Therapy (AYO Glasses)
Device: Bright Light Therapy (AYO Glasses)
BLT intervention
Active Comparator group
Description:
Bright light glasses that emit a more intense therapeutic blue light.
Treatment:
Device: Bright Light Therapy (AYO Glasses)
Device: Bright Light Therapy (AYO Glasses)

Trial documents
1

Trial contacts and locations

2

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Central trial contact

Kenneth L Seldeen, PhD; Bruce R Troen, MD

Data sourced from clinicaltrials.gov

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