Clinical trial NCT05631236: Promoting Cognitive Resilience and Reducing Frailty in Older Veterans With Bright Light Therapy
Official title: Promoting Cognitive Resilience and Reducing Frailty in Older Veterans With Bright Light Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Veteran Aged 65 and Older
Keywords: sleep
aging
veteran
cognition
dementia
functional capacity
frailty
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-11-30
Enrollment: 44
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo control trial.
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep quality
timeFrame: Change from baseline to endpoint at 12 weeks
measure: Step counts
timeFrame: Change from baseline to endpoint at 12 weeks
measure: C-Reactive Protein
timeFrame: Change from baseline to endpoint at 12 weeks
measure: Cognitive screen - SLUMS
timeFrame: Change from baseline to endpoint at 12 weeks
measure: Quality of life assessment
timeFrame: Change from baseline to endpoint at 12 weeks
measure: Brain Derived Neurotrophic Factor (BDNF)
timeFrame: Change from baseline to endpoint at 12 weeks
measure: Sleep chronotype
timeFrame: Change from baseline at 12 weeks
measure: Sleepiness
timeFrame: Change from baseline at 12 weeks
measure: Insomnia
timeFrame: Change from baseline at 12 weeks
measure: Fatigue
timeFrame: Change from baseline at 12 weeks
measure: Anxiety and depression
timeFrame: Change from baseline at 12 weeks
measure: Sleep disorders
timeFrame: Change from baseline at 12 weeks
measure: Sleep quantity
timeFrame: Change from baseline at 12 weeks
measure: Interleukin-6
timeFrame: Change from baseline at 12 weeks
measure: Interleukin-10
timeFrame: Change from baseline at 12 weeks
measure: Amyloid beta 42/40 ratio
timeFrame: Change from baseline at 12 weeks
measure: Phosphorylated tau (P-tau)
timeFrame: Change from baseline at 12 weeks
measure: Cognitive screen - Cognivue
timeFrame: Change from baseline at 12 weeks
measure: Sleep stages
timeFrame: Change from baseline to endpoint at 12 weeks
Secondary outcomes:
measure: Short Physical Performance Battery
timeFrame: Change from baseline to endpoint at 12 weeks
measure: Frailty assessment
timeFrame: Change from baseline to endpoint at 12 weeks
measure: Gait speed
timeFrame: Change from baseline to endpoint at 12 weeks
measure: Muscle strength
timeFrame: Change from baseline to endpoint at 12 weeks
measure: Body Composition (Lean and fat mass)
timeFrame: Change from baseline to endpoint at 12 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Kansas City VA Medical Center, Kansas City, MO
state: Missouri
city: Kansas City
country: United States
facility: Kansas City VA Medical Center, Kansas City, MO
state: Missouri
Study officials:
affiliation: Kansas City VA Medical Center, Kansas City, MO
name: Bruce R. Troen, MD
role: PRINCIPAL_INVESTIGATOR
References: