Trials / Active Not Recruiting
Active Not RecruitingNCT05631236
Promoting Cognitive Resilience and Reducing Frailty in Older Veterans With Bright Light Therapy
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- VA Office of Research and Development · Federal
- Sex
- All
- Age
- 60 Years – 85 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-01-29
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2022-11-30
- Last updated
- 2026-01-27
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05631236. Inclusion in this directory is not an endorsement.