Obstructive Sleep Apnoea in Sarcoidosis

NCT ID: NCT04156789

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 149 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-28
• Study Completion Date: 2021-10-31

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Sarcoidosis group

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

Home sleep apnea testing

Intervention Type: 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

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

Home sleep apnea testing

Intervention Type: 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.

Interventions

Home sleep apnea testing

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Malcolm Kohler

OTHER

Sponsor Role: lead

Responsible Party

Malcolm Kohler

Head of the department of pulmonology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Malcolm Kohler, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 35855534 (View on PubMed)

Other Identifiers

2019-01604

Identifier Type: -

Identifier Source: org_study_id