An observational study in Sarcoidosis, Obstructive Sleep Apnea and Fatigue, sponsored by Malcolm Kohler. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-14.
Sponsored by Malcolm Kohler · Observational
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 149 is above the median of 106 across 386 observational studies indexed under Apnea.
Browse Apnea studies →Malcolm Kohler is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Sarcoidosis group: Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline
vs
Control group: matched control subjects without sarcoidosis
Exclusion Criteria:
Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline
Diagnostic Test: Home sleep apnea testing
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.
Prevalence of OSA in sarcoidosis patients compared to matched controls
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.
Time frame: through one sleep study night
Apnoea-Hypopnea Index (AHI)
AHI will be compared between both groups.
Time frame: through one sleep study night
Fatigue Severity Scale (FAS)
FAS will be compared between both groups. Score ranges from 10 to 50 points with 50 points presenting the most severe form of fatigue.
Time frame: one day
Blood pressure
Blood pressure will be compared between both groups.
Time frame: one day
Lung function test
Lung function tests will be compared between both groups.
Time frame: one day
Puls wave analysis
Applanation-derived augmentation index (AIx) will be compared between both groups.
Time frame: one day
Interleukin-2 blood levels
Association between Interleukin-2 blood levels and OSA severity (AHI) and excessive daytime sleepiness (ESS) in sarcoidosis will be assessed.
Time frame: one day
Oxygen-Desaturation Index (ODI)
ODI will be compared between both groups.
Time frame: through one sleep study night
Epworth Sleepiness Scale (ESS)
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.
Time frame: one day
Functional outcomes of sleep questionnaire (FOSQ)
FOSQ will be compared between both groups. The score ranges from 5 to 20 points. Higher scores indicate better functional status.
Time frame: one day
Short-form-36 (SF-36)
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.
Time frame: one day
Patient Health Questionnaire (PHQ) Module 9
PHQ 9 will be compared between both groups. The test results range between 0 and 27 points. Higher scores indicate severe forms of depression.
Time frame: one day
NoSAS-Score
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.
Time frame: one day
Heart rate
Heart rate will be compared between both groups
Time frame: one day
Neopterin blood level
Association between Neopterin blood levels and OSA severity (AHI) and excessive daytime sleepiness (ESS) in sarcoidosis will be assessed.
Time frame: one day
C-reactive protein (CRP) blood levels
Association between CRP blood levels and OSA severity (AHI) and excessive daytime sleepiness (ESS) in sarcoidosis will be assessed.
Time frame: one day
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Malcolm Kohler