Assessing Fatigue and Attention in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Patients Before and After Treatment With Bright Light Therapy: a Prospective Randomized Controlled Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Chalder Fatigue Score
研究概览
简要总结
In this study patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) will receive bright light therapy through portable lamps for 2 weeks. They will either start with this treatment and then go through a wash-out period of two weeks followed by a wait period of two weeks or they will start with the wait period, followed by a wash-out period, followed by the treatment phase. Patients are asked to fill out questionnaires (rating their level of fatigue) and they go through a standardized computer test assessing their attention levels, both at multiple times throughout the study. The aim of this study is to find out if treatment with bright light will improve subjective fatigue levels and objective attention levels inME/CFS patients.
详细描述
Chronic Fatigue Syndrome (CFS), also referred to as Myalgic Encephalomyelitis (ME), is a chronic, debilitating condition of unknown etiology. Bright light therapy (BLT) has shown promising results in studies investigating its effect in patients with neurological disorders experiencing fatigue symptoms (Mateen et al., 2020, Sinclair et al., 2014, West et al., 2019). Since effective and low to no side effect therapies are duly needed for the treatment of ME/CFS, we propose a randomized-controlled treatment approach with bright light therapy (BLT).
In this proposed study, a total of 38 out-patients with a diagnosis of ME/CFS according to the criteria of the Institute of Medicine will be randomly assigned to a crossover design starting out either with BLT or being waitlisted for the course of two weeks. Portable light boxes emitting full-spectrum visible light with a luminance intensity of 10,000 lux measured at a distance of 50 cm will be used at the participants' home for 2 weeks.
Primary outcome of the study will be the level of fatigue before and after treatment as operationalized by the Chalder Fatigue Score. Secondary outcomes include the objective activity pattern as measured by actigraphy as well as cognitive and metacognitive functioning assessed before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of ME/CFS according to the IOM (IOM, 2015)
- •Chalder Fatigue Score of ≥ 18 points (Likert scoring)
- •age 18-60 years;
- •ability to give informed consent.
排除标准
- •Comorbidities explaining current fatigue symptoms such as sleep-wake disorders (narcolepsy, sleep apnea, periodic limb movements during sleep and irregular sleep-wake-rhythm), untreated hypothyroidism and iatrogenic conditions such as side effects of medication.
- •Previous treatment with BLT (> 10.000 lux) for a duration of >2 weeks.
- •Previously diagnosed medical conditions such as malignancies and hepatitis B or C virus infection.
- •Any past or current diagnosis of bipolar affective disorder; schizophrenia; dementias of any subtype; anorexia nervosa; or bulimia nervosa.
- •Alcohol or other substance abuse disorders within 2 years before the onset of the chronic fatigue and at any time afterward.
- •Severe obesity as defined by a body mass index equal to or greater than
- •Medication use interacting with the circadian rhythm such as regular intake of sleeping pills, sleep-inducing antidepressant medication, and immunosuppressive medication.
- •>20 points in the HDRS-17
- •>10 points in GAD-7 in the psychiatric screening process
- •Pregnancy
- •Change in regimen of ongoing treatment with antidepressants or stimulants within 4 weeks before study inclusion
结局指标
主要结局
Chalder Fatigue Score
时间窗: As a baseline variable: day 1 of inclusion in the study, day 7 before treatment/wait list, day 21 after treatment/wait list, day 35 before treatment/wait list and day 42 after treatment/wait list
subjective Fatigue score
次要结局
- Test of Attentional Performance(On day 7 before treatment/wait list, day 21 after treatment/wait list, day 35 before treatment/wait list and day 42 after treatment/wait list)
研究者
Stefan Seidel
Professor
Medical University of Vienna