Obstructive Sleep Apnoea in Sarcoidosis (OSASA)

Malcolm Kohler

Status: Completed

Conditions: Sarcoidosis; Sleepiness; Fatigue; Obstructive Sleep Apnea

Treatments: Diagnostic Test: Home sleep apnea testing

Study type: Observational

Funder types: Other

Identifiers

NCT04156789

2019-01604

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

149 participants in 2 patient groups

Sarcoidosis group

Description:

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

Treatment:

Diagnostic Test: Home sleep apnea testing

Control group

Description:

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

Treatment:

Diagnostic Test: Home sleep apnea testing