Fatigue, Sarcoidosis, Sleep Apnea, Obstructive
Conditions
Keywords
CPAP
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.
Interventions
DEVICEContinuous 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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline
Exclusion criteria
* Ongoing CPAP treatment * Psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Obstructive Sleep Apnea | 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
| Measure | Time frame | Description |
|---|---|---|
| Impact of Continuous Positive Airway Pressure (CPAP) treatment on fatigue associated status | 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. |
| Impact of Continuous Positive Airway Pressure (CPAP) treatment on daytime sleepiness | 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. |
| Compliance to CPAP treatment | 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. |
| Baseline evaluation of fatigue status | 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. |
| Baseline evaluation sleepiness | 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. |
Countries
Italy
Outcome results
None listed