NCT03926832

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sarcoidosis
• Sleep Apnea, Obstructive
• Fatigue

Interventions

Type	Name	Description
DEVICE	Continuous Positive Airway Pressure (CPAP)	Continuous positive airway pressure (CPAP) is the gold standard for Obstructive Sleep Apnea Syndrome (OSAS) management when moderate-to-severe. Subjects with OSA will be trained in the use of CPAP and will be instructed to use it every night for 3 months. These subjects will then return for a post-treatment completion of questionnaires (ESS and FAS) and compliance analysis.

Timeline

• Start date: 2019-04-27
• Primary completion: 2019-05-15
• Completion: 2019-07-30
• First posted: 2019-04-25
• Last updated: 2019-10-23

Locations

1 site across 1 country: Italy