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NCT03926832: SARCOIDOSAS

Prevalence of Obstructive Sleep Apnea Syndrome in Sarcoidosis and Impact of CPAP Treatment on Associated Fatigue Status

Completed NA Last updated 23 October 2019
What this trial tests

NA trial testing Continuous Positive Airway Pressure (CPAP) in Sarcoidosis in 68 participants. Completed in 30 July 2019.

Timeline
27 April 2019
Primary endpoint
15 May 2019
30 July 2019

Quick facts

Lead sponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment68
Start date27 April 2019
Primary completion15 May 2019
Estimated completion30 July 2019
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

Adults 18 to 85, any sex, with Sarcoidosis or Sleep Apnea, Obstructive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sarcoidosis is a multisystemic granulomatous disease that affects individuals worldwide without known pathogenesis, and the role of comorbidities has not been fully assessed in the scientific literature. An increased incidence of Obstructive Sleep Apnea Syndrome (OSAS) has been described in Sarcoidosis although this association has not been explained yet and no data is available about the effect of treatment with Continuous Positive Airway Pressure (CPAP) in Sarcoidosis. Also, patients affected by Sarcoidosis usually experience a state of physical and mental weariness called fatigue and reported in approximately 60-80% sarcoid patients and thought to be a consequence of inflammatory mediators but the high prevalence of OSAS could be a remarkable bias in clinical evaluation because fatigue is also strongly associated with sleep disorders. Thus, there is a real need for assessing not only the real prevalence of OSAS in Sarcoidosis but also the effect of CPAP treatment on fatigue status experienced by sarcoidotic patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Obstructive sleep apnea in sarcoidosis and impact of cpap treatment on fatigue.
    Mari PV, Pasciuto G, Siciliano M, Simonetti J, et al · · 2020 · cited 13× · PMID 33093780 · DOI 10.36141/svdld.v37i2.9169

Verify or expand the search:

Other trials of Continuous Positive Airway Pressure (CPAP)

Trials testing the same drug.

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Currently open trials in the same condition.

Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03926832.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing