Obstructive Sleep Apnoea in Sarcoidosis

NCT04156789 | Completed

• 1 other identifier: 2019-01604
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoidosis; Obstructive Sleep Apnea; Fatigue; Sleepiness

Outcome Measures

Primary Outcomes (1)

• Prevalence of OSA in sarcoidosis patients compared to matched controls

  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.

  through one sleep study night

Secondary Outcomes (15)

• Apnoea-Hypopnea Index (AHI)

  through one sleep study night

• Fatigue Severity Scale (FAS)

  one day

• Blood pressure

  one day

• Lung function test

  one day

• Puls wave analysis

  one day

Study Arms (2)

Sarcoidosis group

Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline

Diagnostic Test: Home sleep apnea testing

Control group

Control subjects have no sarcoidosis and will be sex, age (± 3 years), height (± 20 cm), and weight (± 15 kg) matched to sarcoidosis patients.

Diagnostic Test: Home sleep apnea testing

Interventions

Home sleep apnea testing DIAGNOSTIC_TEST

Sarcoidosis patients and control subjects will undergo one night of home sleep apnea testing using ApnoeaLinkTM Plus device (ResMed Corporation, Poway, Calif). The device records the patient's nasal respiratory pressure signal as a surrogate of nasal flow, respiratory movements by a thoracic impedance belt, and finger pulse oximetry. The results of the sleep study will be scored automatically with dedicated software (ResMed Corporation, Poway, Calif), and manually reviewed to ensure data accuracy.

Control group; Sarcoidosis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Sarcoidosis group: Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline.
• Informed consent
• years or above
• Control group: No sarcoidosis, no OSA

You may not qualify if:

• 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

Sponsors & Collaborators

• Malcolm Kohler: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35855534 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling to assess inflammation marker: sIL-2-Receptor, Neopterin, Angiotensin Converting Enzyme (ACE) and hsCRP

MeSH Terms

Conditions

Sarcoidosis; Sleep Apnea, Obstructive; Fatigue; Sleepiness

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Malcolm Kohler, Prof

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the department of pulmonology

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 8, 2019
• Study Start: October 28, 2019
• Primary Completion: August 31, 2021
• Study Completion: October 31, 2021
• Last Updated: January 14, 2022

Record last verified: 2022-01

Locations

CH (1)