Obstructive Sleep Apnoea in Sarcoidosis: A Cross-sectional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Prevalence of OSA in sarcoidosis patients compared to matched controls
研究概览
简要总结
Sarcoidosis is a multisystemic granulomatous disease of unknown origin. Fatigue is a common problem in sarcoidosis affecting between 50% and 80% of patients, and thus represents a major impairment of their quality of life.
The findings of recent studies suggest a high prevalence of obstructive sleep apnoea (OSA) in patients with sarcoidosis, estimating a range from 17% to 67%. Pathomechanisms leading to this increased OSA prevalence are still unclear, yet likely to be multifactorial including sarcoid myopathy and neuropathy leading to impaired integrity of the upper airways as well as corticosteroid induced obesity.
While both diseases, Sarcoidosis and OSA, could lead to fatigue and excessive daytime sleepiness (EDS) the current managing strategies differ significantly. OSA patients are mostly treated with continuous positive airway pressure (CPAP) whereas sarcoidosis associated fatigue may require increased immunosuppressive therapy. Little is known about treatment of fatigue and sleepiness in patients suffering from both conditions.This study aims to close this knowledge gap and define prevalence of OSA in a swiss cohort with sarcoidosis patients.
Therefore, we plan a prospective, observational, controlled study to investigate the prevalence of sleepiness, fatigue, life quality and obstructive sleep apnoea in patients with Sarcoidosis.
Patients treated in the University Hospital Zurich due to sarcoidosis will be invited by letter to take part in this study. After confirmed consent and baseline assessments at the University Hospital Zurich, these patients will undergo a single night, in-home sleep study to assess possible OSA.
Sleepiness and fatigue specific questionnaires and in-home respiratory polygraphy (oRP) are obtained in all subjects. To assess inflammation status and other conditions connected to sleepiness like hypothyroidism and anaemia, sarcoidosis patients will undergo blood sampling.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sarcoidosis group: Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline.
- •Informed consent
- •18 years or above
- •Control group: No sarcoidosis, no OSA
排除标准
- •Moribund or severe disease prohibiting protocol adherence
- •Continuous positive airway pressure treatment for OSA at baseline
- •Use of oxygen therapy or home ventilation
- •Physical or intellectual impairment precluding informed consent or protocol adherence
- •Pregnant patients
结局指标
主要结局
Prevalence of OSA in sarcoidosis patients compared to matched controls
时间窗: through one sleep study night
Conventional thresholds according to the American Academy of Sleep Medicine Task Force of AHI ≥5, ≥15 and ≥30 will be used to define mild, moderate and severe OSA respectively. OSA prevalence will be compared between both groups.
次要结局
- Fatigue Severity Scale (FAS)(one day)
- Blood pressure(one day)
- Lung function test(one day)
- Puls wave analysis(one day)
- Functional outcomes of sleep questionnaire (FOSQ)(one day)
- Apnoea-Hypopnea Index (AHI)(through one sleep study night)
- Interleukin-2 blood levels(one day)
- Oxygen-Desaturation Index (ODI)(through one sleep study night)
- Epworth Sleepiness Scale (ESS)(one day)
- Short-form-36 (SF-36)(one day)
- Patient Health Questionnaire (PHQ) Module 9(one day)
- NoSAS-Score(one day)
- Heart rate(one day)
- C-reactive protein (CRP) blood levels(one day)
- Neopterin blood level(one day)
研究者
Malcolm Kohler
Head of the department of pulmonology
University of Zurich