Fatigue Clinical Trial
— SARCOIDOSASOfficial title:
Prevalence of Obstructive Sleep Apnea Syndrome in Sarcoidosis and Impact of CPAP Treatment on Associated Fatigue Status
NCT number | NCT03926832 |
Other study ID # | 2455 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 27, 2019 |
Est. completion date | July 30, 2019 |
Verified date | October 2019 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | July 30, 2019 |
Est. primary completion date | May 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline Exclusion Criteria: - Ongoing CPAP treatment - Psychiatric disorders |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Universitario Agostino Gemelli | Rome |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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