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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive; Fatigue; Sarcoidosis
• Intervention / Treatment: Device: Continuous Positive Airway Pressure (CPAP)

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Policlinico Universitario Agostino Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Ongoing CPAP treatment
• Psychiatric disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

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.; Other Names: positive pressure ventilation; positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of Continuous Positive Airway Pressure (CPAP) treatment on fatigue associated status	Change of "Fatigue Assessment Scale" (FAS) questionnaire result after the start of CPAP treatment in moderate-to-severe OSA patients affected by sarcoidosis. The total score ranges from 10 to 50. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue. The minimal important difference is defined as a reduction of at least 4 points or 10% of baseline value.	Day 1, month 3 of CPAP treatment
Impact of Continuous Positive Airway Pressure (CPAP) treatment on daytime sleepiness	Change of "Epworth Sleepiness Scale" (ESS) questionnaire result after the start of CPAP treatment in moderate-to-severe OSA patients affected by sarcoidosis. Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-1-2-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. A result more than 10 is suggestive of daytime sleepiness. The minimal important difference is defined as a reduction of at least 2 points of baseline value.	Day 1, month 3 of CPAP treatment
Compliance to CPAP treatment	Evaluate the treatment compliance of Sarcoidosis patients affected by moderate-to-severe OSA to CPAP therapy. Good CPAP compliance is defined as using the device for an average of more than 4 hours per night and at least 70% of total nights. Poor CPAP compliance is defined as using the device for an average of less than 4 hours per night and less than 70% of total nights. No compliance to CPAP treatment is defined if a patient refused to start CPAP treatment. Data about average time, percentages of device use during treatment will be determined analyzing the compliance report of the device based on integrated CPAP SD card data storage.	3 month post CPAP treatment
Baseline evaluation of fatigue status	Baseline assessment of fatigue status using the questionnaire "Fatigue Assessment Scale" (FAS). The total score ranges from 10 to 50. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.	Day 1
Baseline evaluation sleepiness	Baseline assessment of sleepiness status using the questionnaire "Epworth Sleepiness Score" (ESS). The total score ranges from 0 to 24. Respondents are asked to rate, on a 4-point scale (0-1-2-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. A result in ESS score more than 10 is suggestive for daytime sleepiness.	Day 1

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Study Director: Luca Richeldi, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 27, 2019
• Primary Completion (ACTUAL): May 15, 2019
• Study Completion (ACTUAL): July 30, 2019

Study Registration Dates

• First Submitted: April 19, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (ACTUAL): April 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: CPAP
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Fatigue; Apnea; Sarcoidosis
• Other Study ID Numbers: 2455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No