The Effect of Nasal CPAP in Patients With Chronic Fatigue and Sleep-disordered Breathing
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: second treatment + effect evaluation.
研究概览
简要总结
Chronic fatigue (CF) and chronic fatigue syndrome (CFS) are disabling disorders that may be induced or aggravated by underlying sleep disturbances. The relationship between sleep quality and fatigue is still not fully elucidated. To evaluate the effect of improved sleep quality on fatigue, a randomized controlled and cross-over trial with nasal continuous positive airway pressure (nCPAP) is carried out in patients who present with a primary complaint of chronic disabling fatigue and who are found to have an apnea-hypopnea index (AHI) >= 15 on polysomnography (PSG).
The aim of this study is to address the issue of Continuous Positive Airway Pressure-responsiveness regarding fatigue as a presenting symptom in CF and CFS patient with obstructive sleep apnea (OSA), in the absence of underlying medical or psychiatric illness. The answer to this question may shed further light on the enigmatic relationship between sleep and fatigue. We also want to investigate the Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population. Zero-hypothesis: there is no effect.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients primarily referred for disabling, unexpected fatigue.
- •According to the Fukuda criteria, diagnostic work-up yields a final diagnosis of chronic fatigue (CF) or chronic fatigue syndrome (CFS).
- •18 <= age <= 65
- •Polysomnography Test (PSG) demonstrates an apnea-hypopnea index (AHI) >=15, as evidence for obstructive sleep apnea (OSA).
- •Female patient of childbearing potential (premenopausal female biologically capable of becoming pregnant) has a confirmed negative pregnancy test at the start of the Continuous Positive Airway Pressure (CPAP) trial and has to employ an acceptable method of birth control.
- •Written, signed and dated informed consent must be obtained from each patient.
- •Patient able to understand and follow the requirements of the study and to comply.
- •Willing to abstain from taking any medication or treatment prohibited in the protocol.
排除标准
- •Patients primarily referred for Excessive Daytime Sleepiness (EDS) or snoring.
- •Fatigue that is explained by medical or psychiatric causes.
- •18 > age > 65
- •Apnea-Hypopnea Index (AHI) < 15
- •Body Mass Index (BMI) >= 40, calculated as weight(m)/(height (m))²
- •Parasomnia
- •Severe sleepiness with (Epworth Sleepiness Scale) ESS >= 16 (=15% of the Chronic fatigue syndrome (CFS) population)
- •Tonsillar hypertrophy (Friedman grade III and IV tonsils)
- •Signs of nasal obstruction, including chronic use of topical nasal drugs.
- •Earlier CPAP treatment
- •Physical and mental disability that compromises the normal use of CPAP
- •CPAP intolerance
- •Current use of sedative (benzodiazepine and non-benzodiazepine GABA-esgic agonist) or antidepressant medication for a time period inferior to 3 weeks.
- •Female patient who is pregnant, lactating or has a positive pregnancy test result.
结局指标
主要结局
Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: second treatment + effect evaluation.
时间窗: Treatment takes 28 days after second evaluation
At the end of the second treatment: effect evaluation. Questionnaires Fatigue Severity Scale (FSS), Checklist Individual Strength(CIS), Visual Analogue Scale for Fatigue (VAS-F) are used.
Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: first treatment + effect evaluation.
时间窗: Treatment takes 28 days after first evaluation
At the end of the first treatment: effect evaluation. Questionnaires Fatigue Severity Scale (FSS), Checklist Individual Strength(CIS), Visual Analogue Scale for Fatigue (VAS-F) are used.
Continuous Positive Airway Pressure-responsiveness regarding fatigue after 28 days: baseline evaluation.
时间窗: At day 0
Baseline evaluation before treatment. Questionnaires Fatigue Severity Scale (FSS), Checklist Individual Strength(CIS), Visual Analogue Scale for Fatigue (VAS-F) are used.
次要结局
- The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: first treatment + effect evaluation.(Treatment takes 28 days after first evaluation)
- The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: second treatment + effect evaluation.(Treatment takes 28 days after second evaluation)
- The Continuous Positive Airway Pressure responsiveness regarding sleepiness and general health in the same target population: baseline evaluation.(At day 0)