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Veteran Aged 65 and OlderBrite-VETNCT05631236

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

A study testing Bright Light Therapy (AYO Glasses) in people with Veteran Aged 65 and Older, run by VA Office of Research and Development at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Veteran Aged 65 and Older
What is being tested?
Bright Light Therapy (AYO Glasses)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
43 participants
Where
1 siteUnited States
Study dates
29 Jan 2024to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site
  • Kansas City VA Medical Center, Kansas City, MO

    Kansas City, Missouri, 64128-2226

Other trials in United States

About this study

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.

Read the 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.

Being tested
Bright Light Therapy (AYO Glasses)
Keywords
sleep, aging, veteran, cognition, dementia, functional capacity, frailty
Medical subject headings
Dementia, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bright Light Therapy (AYO Glasses)Device

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

  • Bright Light Therapy (AYO Glasses)Device

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

Study groups in NCT05631236
Study groupRoleWhat they receive
BLT controlPlacebo comparatorBright light glasses that emit a non-therapeutic blue light.
Receives: Device: Bright Light Therapy (AYO Glasses)
BLT interventionActive comparatorBright light glasses that emit a more intense therapeutic blue light.
Receives: Device: Bright Light Therapy (AYO Glasses)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline to endpoint at 12 weeks

Secondary outcomes (23)
  1. 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.

    Measured: Change from baseline to endpoint at 12 weeks

  2. 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.

    Measured: Change from baseline to endpoint at 12 weeks

  3. Gait speed

    Participants are asked to perform a timed walk of approximately 15 feet in length.

    Measured: Change from baseline to endpoint at 12 weeks

  4. 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.

    Measured: Change from baseline to endpoint at 12 weeks

  5. 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.

    Measured: Change from baseline to endpoint at 12 weeks

  6. 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.

    Measured: Change from baseline at 12 weeks

  7. Sleep quantity

    Objectively measure sleep quantity using FITBIT Charge 5 devices. These devices are worn on the wrist and can measure total sleep time.

    Measured: Change from baseline at 12 weeks

  8. Step counts

    Objectively measure activity using FITBIT Charge 5 actigraphy devices. These devices are worn on the wrist and capture total steps.

    Measured: Change from baseline to endpoint at 12 weeks

  9. 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.

    Measured: Change from baseline to endpoint at 12 weeks

  10. 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.

    Measured: Change from baseline to endpoint at 12 weeks

  11. Sleepiness

    Sleepiness as assessed by the Epworth Sleepiness Scale, which contains 8 self-rated questions with an aggregate score range of 0 to 24.

    Measured: Change from baseline at 12 weeks

  12. Fatigue

    Fatigue as assessed by the Brief Fatigue Inventory, which contains 9 self-rated questions with an aggregate score range of 0 to 90.

    Measured: Change from baseline at 12 weeks

  13. 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.

    Measured: Change from baseline at 12 weeks

  14. 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.

    Measured: Change from baseline at 12 weeks

  15. 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.

    Measured: Change from baseline at 12 weeks

  16. 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.

    Measured: Change from baseline to endpoint at 12 weeks

  17. 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.

    Measured: Change from baseline at 12 weeks

  18. 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.

    Measured: Change from baseline at 12 weeks

  19. Insomnia

    Insomnia as assessed by the Insomnia Severity Index, which contains 7 self-rated questions with an aggregate score range of 0 to 28.

    Measured: Change from baseline at 12 weeks

  20. 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.

    Measured: Change from baseline at 12 weeks

  21. 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.

    Measured: Change from baseline to endpoint at 12 weeks

  22. 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.

    Measured: Change from baseline at 12 weeks

  23. 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.

    Measured: Change from baseline to endpoint at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2022
  2. Study start29 Jan 2024
  3. Primary completion30 Jun 2026
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized placebo control trial.
Masking
Single blind
Who is masked
Participant
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05631236
Sponsor's protocol ID
E4420-P
Other IDs
I21RX004420-01
Acronym
Brite-VET
Status last verified
Jul 2026
First submitted
9 Aug 2022
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Bright Light Therapy (AYO Glasses) in people with Veteran Aged 65 and Older, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep quality (time frame: Change from baseline to endpoint at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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