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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Veteran Aged 65 and Older
• Intervention / Treatment: Device: Bright Light Therapy (AYO Glasses); Device: Bright Light Therapy (AYO Glasses)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Kansas City VA Medical Center, Kansas City, MO
    • Kansas City, Missouri, United States, 64128-2226
      • Kansas City VA Medical Center, Kansas City, MO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: BLT control; Bright light glasses that emit a non-therapeutic blue light.	Device: Bright Light Therapy (AYO Glasses); Bright light glasses that emit a more intense therapeutic blue light.; Device: Bright Light Therapy (AYO Glasses); Bright light glasses that emit a non-therapeutic blue light.
Active Comparator: BLT intervention; Bright light glasses that emit a more intense therapeutic blue light.	Device: Bright Light Therapy (AYO Glasses); Bright light glasses that emit a more intense therapeutic blue light.; Device: Bright Light Therapy (AYO Glasses); Bright light glasses that emit a non-therapeutic blue light.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	Sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI). The PSQI contains 19 self-rated questions that combined to form 7 component scores, each with a range of 0 to 3 points. These in turn are added to yield a global score with a range of 0 to 21 points. Higher scores indicate worse sleep quality.	Change from baseline to endpoint at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition (Lean and fat mass)	Body composition will be measured using bioelectric impedance (BIA) - a technique where participants are asked to stand on the measurement device and hold on to two metal handles. A light - and non-detectable - current is then transmitted allowing for collection of body fat and lean mass in the subject. The assessment takes roughly 2-3 minutes.	Change from baseline to endpoint at 12 weeks
Step counts	Objectively measure activity using FITBIT Charge 5 actigraphy devices. These devices are worn on the wrist and capture total steps.	Change from baseline to endpoint at 12 weeks
C-Reactive Protein	Chronic inflammation may be indicative of distress and lead to chronic diseases. The study will examine the change in C-reactive protein in picograms per milliliter in serum from baseline to endpoint at 12 weeks.	Change from baseline to endpoint at 12 weeks
Brain Derived Neurotrophic Factor (BDNF)	Serum cognitive marker: change in Brain Derived Neurotrophic Factor (BDNF) in picograms per milliliter from baseline to endpoint after 12 weeks.	Change from baseline to endpoint at 12 weeks
Cognitive screen - SLUMS	Cognitive status will be assessed using the VA - St. Louis University Mental Survey (VA-SLUMS) involving memory tests, shape recognition, and story recall. The survey scores range from 0 to 30, with a higher score representing greater cognitive capability.	Change from baseline to endpoint at 12 weeks
Quality of life assessment	Change from baseline to endpoint at 12 weeks Quality of life assessment is performed using the Quality of life, enjoyment, and satisfaction questionnaire - short form (Q-LES-Q-SF) survey instrument. The survey instrument scores from 0 to 70 with a greater score representing better quality of life.	Change from baseline to endpoint at 12 weeks
Sleep chronotype	Sleep chronotype as assessed by the Morningness/Eveningness survey, which contains 19 self-rated questions with an aggregate score range of 19 to 72.	Change from baseline at 12 weeks
Sleepiness	Sleepiness as assessed by the Epworth Sleepiness Scale, which contains 8 self-rated questions with an aggregate score range of 0 to 24.	Change from baseline at 12 weeks
Insomnia	Insomnia as assessed by the Insomnia Severity Index, which contains 7 self-rated questions with an aggregate score range of 0 to 28.	Change from baseline at 12 weeks
Fatigue	Fatigue as assessed by the Brief Fatigue Inventory, which contains 9 self-rated questions with an aggregate score range of 0 to 90.	Change from baseline at 12 weeks
Anxiety and depression	Anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS), which contains 14 self-rated questions with an aggregate score range of 0 to 21. Higher scores indicate greater anxiety and depression.	Change from baseline at 12 weeks
Sleep disorders	Sleep disorders as assessed by the Holland Sleep Disorders Questionnaire, which contains 32 self-rated questions with an aggregate score range of 32 and 160. Higher scores indicate more sleep disorders.	Change from baseline at 12 weeks
Sleep quantity	Objectively measure sleep quantity using FITBIT Charge 5 devices. These devices are worn on the wrist and can measure total sleep time.	Change from baseline at 12 weeks
Interleukin-6	Chronic inflammation may be indicative of distress and lead to chronic diseases. The study will examine the change in interleukin-6 in picograms per milliliter in serum from baseline to endpoint at 12 weeks.	Change from baseline at 12 weeks
Interleukin-10	Chronic inflammation may be indicative of distress and lead to chronic diseases. The study will examine the change in interleukin-10 in picograms per milliliter in serum from baseline to endpoint at 12 weeks.	Change from baseline at 12 weeks
Amyloid beta 42/40 ratio	Serum cognitive marker: change in amyloid beta 42/40 ratio (a unitless measure derived from the ratio of serum amyloid-beta 42 in picograms per milliliter divided by serum amyloid-beta 40 in picograms per milliliter) from baseline to endpoint after 12 weeks.	Change from baseline at 12 weeks
Phosphorylated tau (P-tau)	Serum cognitive marker: plasma levels of phosphorylated tau (P-tau) in picograms per milliliter from baseline to endpoint after 12 weeks.	Change from baseline at 12 weeks
Cognitive screen - Cognivue	Cognivue to assess cognition. This is a computer based combinatorial visual and reaction time test, which is scored 0 to 100. Higher scores indicate better cognitive performance.	Change from baseline at 12 weeks
Sleep stages	Objectively measure duration of sleep stages using FITBIT Charge 5 devices. These devices are worn on the wrist and assess time spent in light, deep, and REM sleep stages.	Change from baseline to endpoint at 12 weeks
Short Physical Performance Battery	The Short physical performance battery (SPPB) is a battery of test often used in geriatric research to capture functional capacity in older adults. The test includes a balance and coordination assessment via asking participants to hold stances with three different foot positions (side-by-side, semi-tandem, and tandem: score 0-4), a gait speed test of approximately 10 feet (score 0-4 based on time), and a chair rise timed test where a participant is asked to rise from a chair 5 times (score 0-4 based on time). The composite score is therefore 0 to 12. Higher scores indicate better performance.	Change from baseline to endpoint at 12 weeks
Frailty assessment	Frailty is a syndrome marked by greater susceptibility to adverse outcomes like falls and disability. We will be using the Fried Frailty Phenotype that includes: 1) unexpected weight loss of 5% or more in the last year or BMI < 18.5; score 0 or 1 if positive, 2) grip strength with BMI dependent cut points for men and women; score 0 or 1 if positive, 3) gait speed with height and sex dependent cutoffs; score 0 or 1 if positive, 4) activity assessed by a survey of the frequency of mild/moderate/energetic physical activity; score of 0 or 1, the latter if positive for hardly ever or never engaging in moderate or energetic physical activity, and 5) endurance assessed by survey of bed rest during the day; score of 0 or 1, the latter if occurring every day or every week. The composite score is therefore 0 to 5. Higher scores indicate more frailty.	Change from baseline to endpoint at 12 weeks
Gait speed	Participants are asked to perform a timed walk of approximately 15 feet in length.	Change from baseline to endpoint at 12 weeks
Muscle strength	Change from baseline to endpoint at 12 weeks Leg and arm strength will be measured using a small handheld dynamometer where the device is placed on the wrist or ankle as the participant is asked to extend or contract the limb with full force.	Change from baseline to endpoint at 12 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Bruce R. Troen, MD, Kansas City VA Medical Center, Kansas City, MO

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: sleep; dementia; frailty; cognition; aging; veteran; functional capacity
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Frailty; Dementia; Therapeutics; Phototherapy; Ultraviolet Therapy
• Other Study ID Numbers: E4420-P; I21RX004420-01 (U.S. NIH Grant/Contract: VA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Final data sets will be made available upon specific request and under an authorized Data Use Agreement. This, in addition to the publications being made available via PubMed Central, will enable validation of results by recipients.
• IPD Sharing Time Frame: After analysis and completion of study along with subsequent publication of results.
• IPD Sharing Access Criteria: After analysis and completion of study along with subsequent publication of results.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No