Clinical trial NCT04156789: Obstructive Sleep Apnoea in Sarcoidosis
Official title: Obstructive Sleep Apnoea in Sarcoidosis: A Cross-sectional Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Obstructive Sleep Apnea
Fatigue
Sleepiness
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sarcoidosis group: Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline

vs

Control group: matched control subjects without sarcoidosis

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prevalence of OSA in sarcoidosis patients compared to matched controls
timeFrame: through one sleep study night
Secondary outcomes:
measure: Apnoea-Hypopnea Index (AHI)
timeFrame: through one sleep study night
measure: Fatigue Severity Scale (FAS)
timeFrame: one day
measure: Blood pressure
timeFrame: one day
measure: Lung function test
timeFrame: one day
measure: Puls wave analysis
timeFrame: one day
measure: Interleukin-2 blood levels
timeFrame: one day
measure: Oxygen-Desaturation Index (ODI)
timeFrame: through one sleep study night
measure: Epworth Sleepiness Scale (ESS)
timeFrame: one day
measure: Functional outcomes of sleep questionnaire (FOSQ)
timeFrame: one day
measure: Short-form-36 (SF-36)
timeFrame: one day
measure: Patient Health Questionnaire (PHQ) Module 9
timeFrame: one day
measure: NoSAS-Score
timeFrame: one day
measure: Heart rate
timeFrame: one day
measure: Neopterin blood level
timeFrame: one day
measure: C-reactive protein (CRP) blood levels
timeFrame: one day
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Malcolm Kohler, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roeder M, Sievi NA, Schneider A, Osswald M, Malesevic S, Kolios A, Nilsson J, Kohler M, Franzen D. The prevalence of obstructive sleep apnea in sarcoidosis and its impact on sleepiness, fatigue, and sleep-associated quality of life: a cross-sectional study with matched controls (the OSASA study). J Clin Sleep Med. 2022 Oct 1;18(10):2415-2422. doi: 10.5664/jcsm.10140.