Promoting Cognitive Resilience and Reducing Frailty in Older Veterans With Bright Light Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Veteran Aged 65 and Older

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized placebo control trial.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Bright light therapy devices include two sets: intervention that emit blue light and the control that emits light at a non-therapeutic intensity.

Study Groups

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BLT control

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

Group Type PLACEBO_COMPARATOR

Bright Light Therapy (AYO Glasses)

Intervention Type DEVICE

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

BLT intervention

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

Group Type ACTIVE_COMPARATOR

Bright Light Therapy (AYO Glasses)

Intervention Type DEVICE

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

Interventions

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Bright Light Therapy (AYO Glasses)

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

Intervention Type DEVICE

Bright Light Therapy (AYO Glasses)

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes