Bright Light Therapy to Treat Fatigue in End Stage Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fatigue Severity Scale
研究概览
简要总结
The goal of this clinical trial is to test light therapy in patients with end stage kidney disease who are receiving hemodialysis. The main aim is to determine if light therapy decreases fatigue severity. Participants will receive light therapy using special glasses for one hour during the dialysis sessions for four weeks of treatment.
详细描述
In a single site, 2-arm (Bright Light Therapy group; Dim Light Group), parallel, randomized controlled trial we will enroll 60 subjects (n=30 per group) to assess the effects of Bright Light Therapy compared to Dim Light Therapy in subjects with end stage kidney disease who are receiving hemodialysis to treat fatigue.
- To compare the effects of bright light therapy to dim light therapy on fatigue severity.
- To explore the effects of bright light therapy to dim light therapy on salivary cortisol.
- To compare the effects of bright light therapy to dim light therapy on insomnia, depression and quality of life.
- To test the effects on bright light therapy to dim light therapy on physical activity levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to initiation of any study mandated procedure
- •Male and female participants ≥ 18 years of age
- •Diagnosis end stage kidney disease with hemodialysis 3 times/week for at least 1 month
- •Fatigue Severity Scale (FSS) > 9 at enrollment
- •Home refrigerator for salivary cortisol storage
排除标准
- •Eye disorders: cataracts, glaucoma, retinal disorders (e.g. macular degeneration)
- •Participants with photosensitivity (e.g. epilepsy)
- •Hospitalized or acutely ill
研究组 & 干预措施
Bright Light
Light therapy will be delivered by the Re-Timer glasses for 60 minutes during dialysis sessions.
干预措施: Bright light (Device)
Dim Light
Dim light therapy will be delivered by the Re-Timer glasses for 60 minutes during dialysis sessions.
干预措施: Dim Light (Device)
结局指标
主要结局
Fatigue Severity Scale
时间窗: 4 weeks
Measures how bad or severe a person's fatigue is. Score range from 9-63; higher scores indicate increased fatigue.
次要结局
未报告次要终点