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NCT Number: NCT04156789

Obstructive Sleep Apnoea in Sarcoidosis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Prevalence of OSA in sarcoidosis patients compared to matched controls

    Time frame: 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.

Secondary outcomes

  1. Apnoea-Hypopnea Index (AHI)

    Time frame: through one sleep study night

    AHI will be compared between both groups.

  2. Fatigue Severity Scale (FAS)

    Time frame: one day

    FAS will be compared between both groups. Score ranges from 10 to 50 points with 50 points presenting the most severe form of fatigue.

  3. Blood pressure

    Time frame: one day

    Blood pressure will be compared between both groups.

  4. Lung function test

    Time frame: one day

    Lung function tests will be compared between both groups.

  5. Puls wave analysis

    Time frame: one day

    Applanation-derived augmentation index (AIx) will be compared between both groups.

  6. Interleukin-2 blood levels

    Time frame: one day

    Association between Interleukin-2 blood levels and OSA severity (AHI) and excessive daytime sleepiness (ESS) in sarcoidosis will be assessed.

  7. Oxygen-Desaturation Index (ODI)

    Time frame: through one sleep study night

    ODI will be compared between both groups.

  8. Epworth Sleepiness Scale (ESS)

    Time frame: one day

    ESS will be compared between both groups. The test measures subjective sleepiness. The scale ranges from 0 to 24 points. More points indicate higher sleepiness.

  9. Functional outcomes of sleep questionnaire (FOSQ)

    Time frame: one day

    FOSQ will be compared between both groups. The score ranges from 5 to 20 points. Higher scores indicate better functional status.

  10. Short-form-36 (SF-36)

    Time frame: one day

    SF-36 will be compared between both groups. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

  11. Patient Health Questionnaire (PHQ) Module 9

    Time frame: one day

    PHQ 9 will be compared between both groups. The test results range between 0 and 27 points. Higher scores indicate severe forms of depression.

  12. NoSAS-Score

    Time frame: one day

    NoSAS-Score will be compared between both groups. The score ranges from 0-17 points. The patient has a high probability of sleep disordered breathing if he has a NoSAS-Score of 8 or higher.

  13. Heart rate

    Time frame: one day

    Heart rate will be compared between both groups

  14. Neopterin blood level

    Time frame: one day

    Association between Neopterin blood levels and OSA severity (AHI) and excessive daytime sleepiness (ESS) in sarcoidosis will be assessed.

  15. C-reactive protein (CRP) blood levels

    Time frame: one day

    Association between CRP blood levels and OSA severity (AHI) and excessive daytime sleepiness (ESS) in sarcoidosis will be assessed.

Sponsors and collaborators

Lead sponsor

Malcolm Kohler

Other

Registry information

Official study title

Obstructive Sleep Apnoea in Sarcoidosis: A Cross-sectional Observational Study

Acronym: OSASA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 8, 2019
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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