Control Fatigue: Sleep Medical Treatment as a Novel Therapeutic Approach to an Unmet Medical Need in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Modified Fatigue Impact Scale value
研究概览
简要总结
This study evaluates the effect of an extensive sleep medical investigation and of the subsequent treatment on multiple sclerosis (MS) related fatigue (provided a previously unknown sleep disorder was found).
详细描述
Fatigue is among the most frequent symptoms in multiple sclerosis (MS) patients with substantial negative impact on quality of life and employment status; one third of patients describe fatigue as their most burdensome symptom. The enormous personal and socioeconomic burden of this symptom is in striking contrast to the limited therapeutic options.
In a previous polysomnographic study, we found a strong association between sleep disorders and fatigue in MS, measured with the Modified Fatigue Impact Scale (MFIS) and the Fatigue-Severity-Scale (FSS). Thus, it is conceivable that a consequent treatment of sleep disorders may improve fatigue, at least in a subset of patients which would yield a great benefit as pharmacological treatment options for fatigue are insufficient.
All consecutive MS patients of our outpatient clinic will be screened for fatigue. In case of fatigue (MFIS values > 34) or signs of sleep disorders (Pittsburgh sleep quality index > 5) the MS patients were invited to participate in the study. All MS patients will be interviewed by a sleep specialist, and will fill out questionnaires. Afterwards, they will be investigated by two consecutive polysomnographies in the sleep laboratory, followed (if necessary) by multiple sleep latencies tests. Subsequently, a sleep medical diagnosis will be established (no sleep disorder or sleep apnea or insomnia or restless legs syndrome or any other sleep disorders according to the International Classification of Sleep disorders 3th ed.). The primary endpoint will be the Modified Fatigue Impact Scale (MFIS) value six months after sleep medical treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •multiple sclerosis
- •MFIS values greater than 34 or Pittsburgh Sleep Quality Index greater than 5
排除标准
- •Expanded disability status scale greater than 5
- •relapse in the last four weeks
- •immunosuppressants in the last two years
- •therapy with positive airway pressure (CPAP or BIPAP/ASV)
- •treatment with opioids
- •treatment with oestrogen
- •body mass index greater than 40
- •depression (beck depression inventory (BDI) values greater 20; in case of treatment with antidepressants BDI values greater than 12 or suicidal ideas)
- •pregnancy
- •anaemia (hemoglobine < 11,5 g/dl in women and < 12,5 g/dl in men)
- •thyroid-stimulating hormone outside the normal range
- •renal insufficiency (creatinine clearance < 75ml/min)
- •elevated transaminases (tripled)
- •chronic heart failure (NYHA II, III or IV)
- •respiratory insufficiency (CO2 > 45 mmHg or pO2 < 60 mmHg (capillary or arterial) or long-term oxygen therapy)
- •carcinoma in the medical history (except for curative approach without relapse in the last 10 years)
- •chemotherapy
- •poorly controlled diabetes (Glycated hemoglobin greater than 8 per cent)
- •pituitary adenomas
- •diabetes insipidus
- •fibromyalgia
- •unclear weight loss greater than 12 kg in one year
- •myasthenia gravis or any neuromuscular disorder
- •ulcerating colitis or Crohn's disease
- •AIDS or infection with HIV
- •acute infection in the last two months
- •stroke or apoplexy in the history
- •Parkinson's Disease
- •substance or drug abuse
- •participation in other interventional trials
- •capacity for consent is lacking
研究组 & 干预措施
Treatment group
Standard Treatment of Sleep disorder according to applicable guideline
干预措施: Sleep medical treatment (Other)
Waiting list
Continuation of former treatment, after completing the study standard treatment of Sleep disorder according to applicable guidelines
结局指标
主要结局
Modified Fatigue Impact Scale value
时间窗: six months after treatment
Measuring fatigue Total value of the Modified Fatigue Impact Scale: 0-84 (min-max), higher values represent increased fatigue, and lower values are considered to be a better outcome
次要结局
未报告次要终点
研究者
Friedemann Paul
Prof. Dr. Friedemann Paul
Charite University, Berlin, Germany