Promoting Cognitive Resilience and Reducing Frailty in Older Veterans With Bright Light Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Sleep quality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Bright light therapy devices include two sets: intervention that emit blue light and the control that emits light at a non-therapeutic intensity.
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BLT control
Bright light glasses that emit a non-therapeutic blue light.
干预措施: Bright Light Therapy (AYO Glasses) (Device)
BLT intervention
Bright light glasses that emit a more intense therapeutic blue light.
干预措施: Bright Light Therapy (AYO Glasses) (Device)
结局指标
主要结局
Sleep quality
时间窗: 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.
Sleep quality
时间窗: 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.
次要结局
- Short Physical Performance Battery(Change from baseline to endpoint at 12 weeks)
- Frailty assessment(Change from baseline to endpoint at 12 weeks)
- Gait speed(Change from baseline to endpoint at 12 weeks)
- Muscle strength(Change from baseline to endpoint at 12 weeks)
- Body Composition (Lean and fat mass)(Change from baseline to endpoint at 12 weeks)
- Interleukin-6(Change from baseline at 12 weeks)
- Sleep quantity(Change from baseline at 12 weeks)
- Step counts(Change from baseline to endpoint at 12 weeks)
- Cognitive screen - SLUMS(Change from baseline to endpoint at 12 weeks)
- Brain Derived Neurotrophic Factor (BDNF)(Change from baseline to endpoint at 12 weeks)
- Sleepiness(Change from baseline at 12 weeks)
- Fatigue(Change from baseline at 12 weeks)
- Sleep disorders(Change from baseline at 12 weeks)
- Amyloid beta 42/40 ratio(Change from baseline at 12 weeks)
- Cognitive screen - Cognivue(Change from baseline at 12 weeks)
- Sleep stages(Change from baseline to endpoint at 12 weeks)
- Phosphorylated tau (P-tau)(Change from baseline at 12 weeks)
- Interleukin-10(Change from baseline at 12 weeks)
- Insomnia(Change from baseline at 12 weeks)
- Sleep chronotype(Change from baseline at 12 weeks)
- Quality of life assessment(Change from baseline to endpoint at 12 weeks)
- Anxiety and depression(Change from baseline at 12 weeks)
- C-Reactive Protein(Change from baseline to endpoint at 12 weeks)
- Sleepiness(Change from baseline at 12 weeks)
- Fatigue(Change from baseline at 12 weeks)
- Sleep disorders(Change from baseline at 12 weeks)
- Amyloid beta 42/40 ratio(Change from baseline at 12 weeks)
- Cognitive screen - Cognivue(Change from baseline at 12 weeks)
- Sleep stages(Change from baseline to endpoint at 12 weeks)
- Phosphorylated tau (P-tau)(Change from baseline at 12 weeks)
- Interleukin-10(Change from baseline at 12 weeks)
- Quality of life assessment(Change from baseline to endpoint at 12 weeks)
- Anxiety and depression(Change from baseline at 12 weeks)
- C-Reactive Protein(Change from baseline to endpoint at 12 weeks)
- Short Physical Performance Battery(Change from baseline to endpoint at 12 weeks)
- Frailty assessment(Change from baseline to endpoint at 12 weeks)
- Gait speed(Change from baseline to endpoint at 12 weeks)
- Muscle strength(Change from baseline to endpoint at 12 weeks)
- Body Composition (Lean and fat mass)(Change from baseline to endpoint at 12 weeks)
- Interleukin-6(Change from baseline at 12 weeks)
- Sleep quantity(Change from baseline at 12 weeks)
- Step counts(Change from baseline to endpoint at 12 weeks)
- Cognitive screen - SLUMS(Change from baseline to endpoint at 12 weeks)
- Brain Derived Neurotrophic Factor (BDNF)(Change from baseline to endpoint at 12 weeks)