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Trial record 1 of 22 for:    kohler malcolm
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Obstructive Sleep Apnoea in Sarcoidosis (OSASA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date October 30, 2019
First Posted Date November 8, 2019
Last Update Posted Date November 8, 2019
Actual Study Start Date October 28, 2019
Estimated Primary Completion Date October 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 5, 2019)
  • Apnoea-Hypopnea Index (AHI) [ Time Frame: through one sleep study night ]
    AHI will be compared between both groups.
  • 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.
  • Blood pressure [ Time Frame: one day ]
    Blood pressure will be compared between both groups.
  • Lung function test [ Time Frame: one day ]
    Lung function tests will be compared between both groups.
  • Puls wave analysis [ Time Frame: one day ]
    Applanation-derived augmentation index (AIx) will be compared between both groups.
  • 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.
  • Oxygen-Desaturation Index (ODI) [ Time Frame: through one sleep study night ]
    ODI will be compared between both groups.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Heart rate [ Time Frame: one day ]
    Heart rate will be compared between both groups
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Obstructive Sleep Apnoea in Sarcoidosis
Official Title Obstructive Sleep Apnoea in Sarcoidosis: A Cross-sectional Observational Study
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood sampling to assess inflammation marker: sIL-2-Receptor, Neopterin, Angiotensin Converting Enzyme (ACE) and hsCRP
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

Condition
  • Sarcoidosis
  • Obstructive Sleep Apnea
  • Fatigue
  • Sleepiness
Intervention 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.
Study Groups/Cohorts
  • Sarcoidosis group
    Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline
    Intervention: 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.
    Intervention: Diagnostic Test: Home sleep apnea testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 5, 2019)
71
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 15, 2021
Estimated Primary Completion Date October 15, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
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
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04156789
Other Study ID Numbers 2019-01604
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Malcolm Kohler, University of Zurich
Study Sponsor Malcolm Kohler
Collaborators Not Provided
Investigators
Principal Investigator: Malcolm Kohler, Prof University of Zurich
PRS Account University of Zurich
Verification Date November 2019