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Obstructive Sleep Apnoea in Sarcoidosis (OSASA)

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ClinicalTrials.gov Identifier: NCT04156789
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Malcolm Kohler, University of Zurich

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.


Condition or disease Intervention/treatment
Sarcoidosis Obstructive Sleep Apnea Fatigue Sleepiness Diagnostic Test: Home sleep apnea testing

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Study Type : Observational
Estimated Enrollment : 71 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Obstructive Sleep Apnoea in Sarcoidosis: A Cross-sectional Observational Study
Actual Study Start Date : October 28, 2019
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Sarcoidosis group
Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline
Diagnostic Test: 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.

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
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 Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Blood sampling to assess inflammation marker: sIL-2-Receptor, Neopterin, Angiotensin Converting Enzyme (ACE) and hsCRP


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156789


Contacts
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Contact: Malcolm Kohler, Prof +41 44 255 38 28 malcolm.kohler@usz.ch
Contact: Maurice Roeder, Dr +41 44 255 48 01 maurice.roeder@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zürich, Switzerland, 8091
Contact: Malcolm Kohler, Prof    +41 44 255 38 28    malcolm.kohler@usz.ch   
Contact: Maurice Roeder, Dr    +41 44 255 48 01    maurice.roeder@usz.ch   
Sponsors and Collaborators
Malcolm Kohler
Investigators
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Principal Investigator: Malcolm Kohler, Prof University of Zurich

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Responsible Party: Malcolm Kohler, Head of the department of pulmonology, University of Zurich
ClinicalTrials.gov Identifier: NCT04156789     History of Changes
Other Study ID Numbers: 2019-01604
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sarcoidosis
Fatigue
Sleepiness
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Lymphoproliferative Disorders
Lymphatic Diseases