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

NCT ID: NCT03926832

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-27
• Study Completion Date: 2019-07-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with Sarcoidosis

Participants with Sarcoidosis. This arm will complete baseline questionnaires assessing daytime sleepiness (Epworth Sleepiness Scale - ESS) and fatigue (Fatigue Assessment Scale - FAS). All participants will perform home polygraphy and will be treated with CPAP for three months if moderate-to-severe OSA has been diagnosed and re-assessed with the same questionnaires along with a complete analysis of CPAP adherence by analyzing the compliance report of the device.

Group Type: EXPERIMENTAL

Continuous Positive Airway Pressure (CPAP)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

positive airway pressure; positive pressure ventilation

Eligibility Criteria

Inclusion Criteria

• Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline

Exclusion Criteria

• Ongoing CPAP treatment
• Psychiatric disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Pier Valerio Mari

Pulmonary and Critical Care Medicine (P/CCM) senior fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luca Richeldi, MD, PhD

Role: STUDY_DIRECTOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

Policlinico Universitario Agostino Gemelli

Rome, , Italy

Countries

Italy

Other Identifiers

2455

Identifier Type: -

Identifier Source: org_study_id