Prevalence of Obstructive Sleep Apnea Syndrome in Sarcoidosis and Impact of CPAP Treatment on Associated Fatigue Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Prevalence of Obstructive Sleep Apnea
研究概览
简要总结
Sarcoidosis is a multisystemic granulomatous disease that affects individuals worldwide without known pathogenesis, and the role of comorbidities has not been fully assessed in the scientific literature. An increased incidence of Obstructive Sleep Apnea Syndrome (OSAS) has been described in Sarcoidosis although this association has not been explained yet and no data is available about the effect of treatment with Continuous Positive Airway Pressure (CPAP) in Sarcoidosis. Also, patients affected by Sarcoidosis usually experience a state of physical and mental weariness called fatigue and reported in approximately 60-80% sarcoid patients and thought to be a consequence of inflammatory mediators but the high prevalence of OSAS could be a remarkable bias in clinical evaluation because fatigue is also strongly associated with sleep disorders.
Thus, there is a real need for assessing not only the real prevalence of OSAS in Sarcoidosis but also the effect of CPAP treatment on fatigue status experienced by sarcoidotic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline
排除标准
- •Ongoing CPAP treatment
- •Psychiatric disorders
结局指标
主要结局
Prevalence of Obstructive Sleep Apnea
时间窗: Day 1
Number of participants for whom polysomnography has shown an Apnea Hypopnea Index (AHI) more than 5 events/hour. Mild OSA is defined as AHI between 5 and 15 events/hour. Moderate OSA is defined as AHI between 15 and 30 events/hour. Severe OSA is defined as AHI more than 30 events/hour.
次要结局
- Impact of Continuous Positive Airway Pressure (CPAP) treatment on fatigue associated status(Day 1, month 3 of CPAP treatment)
- Compliance to CPAP treatment(3 month post CPAP treatment)
- Baseline evaluation of fatigue status(Day 1)
- Impact of Continuous Positive Airway Pressure (CPAP) treatment on daytime sleepiness(Day 1, month 3 of CPAP treatment)
- Baseline evaluation sleepiness(Day 1)
研究者
Pier Valerio Mari
Pulmonary and Critical Care Medicine (P/CCM) senior fellow
Fondazione Policlinico Universitario Agostino Gemelli IRCCS