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NCT Number: NCT03926832

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Ongoing CPAP treatment
  • Psychiatric disorders

Treatment and study plan

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.

Other names: positive airway pressure, positive pressure ventilation

Primary outcomes

  1. Prevalence of Obstructive Sleep Apnea

    Time frame: Day 1

    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.

Secondary outcomes

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

    Time frame: Day 1, month 3 of CPAP treatment

    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.

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

    Time frame: Day 1, month 3 of CPAP treatment

    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.

  3. Compliance to CPAP treatment

    Time frame: 3 month post 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.

  4. Baseline evaluation of fatigue status

    Time frame: Day 1

    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.

  5. Baseline evaluation sleepiness

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: SARCOIDOSAS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 25, 2019
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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