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.
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
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.
- Conditions
- Veteran Aged 65 and Older
- 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 group | Role | What they receive |
|---|---|---|
| BLT control | Placebo comparator | Bright light glasses that emit a non-therapeutic blue light. Receives: Device: Bright Light Therapy (AYO Glasses) |
| BLT intervention | Active comparator | Bright 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted30 Nov 2022
- Study start29 Jan 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Veteran Aged 65 and OlderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Bruce R. Troen, MD, Principal investigator, Kansas City VA Medical Center, Kansas City, MO
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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Cognitive Resilience and Reducing Frailty in Older Veterans With Bright Light Therapy
- ClinicalTrials.gov ID
- NCT05631236
- Acronym / sponsor ID
- Brite-VET / E4420-P
- Conditions
- Veteran Aged 65 and Older
- Keywords
- sleep, aging, veteran, cognition, dementia, functional capacity, frailty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized placebo control trial.
| Arm | Type | Receives |
|---|---|---|
| BLT control | Placebo comparator | Device: Bright Light Therapy (AYO Glasses)Bright light glasses that emit a non-therapeutic blue light. |
| BLT intervention | Active comparator | Device: Bright Light Therapy (AYO Glasses)Bright light glasses that emit a more intense therapeutic blue light. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Light Therapy (AYO Glasses)Bright light glasses that emit a more intense therapeutic blue light. | Device | BLT intervention |
| Bright Light Therapy (AYO Glasses)Bright light glasses that emit a non-therapeutic blue light. | Device | BLT control |
Primary outcome
Sleep quality
Time frame: Change from baseline to endpoint at 12 weeks
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.
23 secondary outcomes
Short Physical Performance Battery
Time frame: Change from baseline to endpoint at 12 weeks
Frailty assessment
Time frame: Change from baseline to endpoint at 12 weeks
Gait speed
Time frame: Change from baseline to endpoint at 12 weeks
Muscle strength
Time frame: Change from baseline to endpoint at 12 weeks
Body Composition (Lean and fat mass)
Time frame: Change from baseline to endpoint at 12 weeks
Interleukin-6
Time frame: Change from baseline at 12 weeks
Sleep quantity
Time frame: Change from baseline at 12 weeks
Step counts
Time frame: Change from baseline to endpoint at 12 weeks
Cognitive screen - SLUMS
Time frame: Change from baseline to endpoint at 12 weeks
Brain Derived Neurotrophic Factor (BDNF)
Time frame: Change from baseline to endpoint at 12 weeks
Sleepiness
Time frame: Change from baseline at 12 weeks
Fatigue
Time frame: Change from baseline at 12 weeks
Sleep disorders
Time frame: Change from baseline at 12 weeks
Amyloid beta 42/40 ratio
Time frame: Change from baseline at 12 weeks
Cognitive screen - Cognivue
Time frame: Change from baseline at 12 weeks
Sleep stages
Time frame: Change from baseline to endpoint at 12 weeks
Phosphorylated tau (P-tau)
Time frame: Change from baseline at 12 weeks
Interleukin-10
Time frame: Change from baseline at 12 weeks
Insomnia
Time frame: Change from baseline at 12 weeks
Sleep chronotype
Time frame: Change from baseline at 12 weeks
Quality of life assessment
Time frame: Change from baseline to endpoint at 12 weeks
Anxiety and depression
Time frame: Change from baseline at 12 weeks
C-Reactive Protein
Time frame: Change from baseline to endpoint at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce R. Troen, MD principal investigator
Kansas City VA Medical Center, Kansas City, MO
1 site in 1 country: see every site and its status.
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.