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

NCT03926832 | Completed

• 1 other identifier: 2455
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Keywords

CPAP

Outcome Measures

Primary Outcomes (1)

• Prevalence of Obstructive Sleep Apnea

  Number of participants for whom polysomnography has shown an Apnea Hypopnea Index (AHI) more than 5 events/hour. Mild OSA is defined as AHI between 5 and 15 events/hour. Moderate OSA is defined as AHI between 15 and 30 events/hour. Severe OSA is defined as AHI more than 30 events/hour.

  Day 1

Secondary Outcomes (5)

• Impact of Continuous Positive Airway Pressure (CPAP) treatment on fatigue associated status

  Day 1, month 3 of CPAP treatment

• Impact of Continuous Positive Airway Pressure (CPAP) treatment on daytime sleepiness

  Day 1, month 3 of CPAP treatment

• Compliance to CPAP treatment

  3 month post CPAP treatment

• Baseline evaluation of fatigue status

  Day 1

• Baseline evaluation sleepiness

  Day 1

Study Arms (1)

Patients with Sarcoidosis

EXPERIMENTAL

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.

Device: Continuous Positive Airway Pressure (CPAP)

Interventions

Continuous Positive Airway Pressure (CPAP) 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.

Also known as: positive airway pressure, positive pressure ventilation

Patients with Sarcoidosis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Ongoing CPAP treatment
• Psychiatric disorders

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Sarcoidosis; Sleep Apnea, Obstructive; Fatigue

Interventions

Continuous Positive Airway Pressure; Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Luca Richeldi, MD, PhD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary and Critical Care Medicine (P/CCM) senior fellow

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 25, 2019
• Study Start: April 27, 2019
• Primary Completion: May 15, 2019
• Study Completion: July 30, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)