Treatment of Post-TBI Fatigue With Light Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Multidimensional Assessment of Fatigue (MAF)
研究概览
简要总结
This study aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month follow up. The investigators hypothesize that individuals receiving 4 weeks of bright white light treatment will report significant reductions in fatigue compared to individuals receiving dim red light treatment for the same duration of time, and that these treatment effects will be maintained one month after treatment completion.
详细描述
To determine the efficacy of bright white light exposure compared to dim red light exposure in reducing post-TBI fatigue, an 8-week, randomized parallel-group clinical trial will be performed. Outcome assessment will be blinded. Participants will complete a baseline battery (T1) including 72 hours of actigraphy. Participants will then be randomized to either the Bright White Light (BWL) or the Dim Red Light (DRL) group. After 4 weeks of daily, 30-minute light treatments, the baseline battery will be re-administered (T2) along with 3 more days of Actigraphy. A follow-up assessment involving the same measures will be administered 1 month-post cessation of light therapy (T3). Participant treatment allocations will be masked for research team members conducting outcome measures. Secondary outcome measures will be administered to explore the effects of light therapy on mood, daytime sleepiness, sleep quality, circadian rhythms, anxiety, cognition and life satisfaction.
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
- Single (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
- •Documented TBI of any severity
- •At least 6 months post injury
- •Presence of clinically significant fatigue, operationalized as a score of 22 or more on the Multidimensional Assessment of Fatigue
- •Age 18 or older
- •English speaking
排除标准
- •Neurological disease other than TBI
- •Pregnancy (because of pregnancy fatigue)
- •Medical illness causing fatigue, such as anemia, hypothyroidism, HIV, renal failure, cirrhosis or cancer treatment in the past year
- •Current major depressive episode or substance abuse
- •Diagnosed sleep disorder or high risk for sleep apnea
- •History of bipolar disorder or manic or hypomanic episodes
- •Current chronic, severe headaches
- •Sensitivity to bright light
- •History of retinal damage or disease
研究组 & 干预措施
Bright White Light (BWL)
Participants will self-administer bright white light daily using a Litebook® (The Litebook Company Ltd.). The Litebook is a small (6" x 5" x 1") and lightweight (8 oz.) box.
干预措施: Bright White Light (BWL) (Device)
Dim Red Light (DRL)
Participants will self-administer dim red light daily using a device that appears identical to Bright White Light (BWL) Litebook but that uses red LEDs emitting DRL.
干预措施: Dim Red Light (DRL) (Device)
结局指标
主要结局
Multidimensional Assessment of Fatigue (MAF)
时间窗: baseline, 4 weeks, 8 weeks
Multidimensional Assessment of Fatigue (MAF) yields a Global Fatigue Index (GFI), assessing 5 dimensions of fatigue: distress, degree, severity, impact on ADLs and frequency of fatigue in the past week, and it yields a composite score. GFI full score from 0-50, with a higher score indicating more severe fatigue, fatigue distress, or impact on activities of daily living.
次要结局
- Actiwatch Spectrum - Acrophase(4 weeks post treatment)
- TBI-QOL Fatigue(baseline, 4 weeks, 8 weeks)
- Neuro-QOL Depression and Sleep(baseline, 4 weeks, 8 weeks)
- Epworth Sleepiness Scale (ESS)(baseline, 4 weeks, 8 weeks)
- CNS Vital Signs TBI Rehab Toolbox(baseline, 4 weeks, 8 weeks)
- Cognitive Failures Questionnaire(baseline, 4 weeks, 8 weeks)
- Neuro-QOL Anxiety(baseline, 4 weeks, 8 weeks)
- Actiwatch Spectrum - Mesor(4 weeks post treatment)
- Actiwatch Spectrum - F Statistic(4 weeks post treatment)
- Satisfaction With Life Scale(baseline, 4 weeks, 8 weeks)
- Treatment Satisfaction Questionnaire for Medication(at 4 weeks (end-of-treatment))
- Credibility/Expectancy Questionnaire(at 4 weeks (end-of-treatment))
研究者
Kristen Dams-O'Connor
Associate Professor
Icahn School of Medicine at Mount Sinai