SarcoidosisSARCOIDOSASNCT03926832
Prevalence of Obstructive Sleep Apnea Syndrome in Sarcoidosis and Impact of CPAP Treatment on Associated Fatigue Status
A study testing Continuous Positive Airway Pressure (CPAP) in people with Sarcoidosis and Sleep Apnea, Obstructive, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sarcoidosis, Sleep Apnea, Obstructive, Fatigue
- What is being tested?
- Continuous Positive Airway Pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- 27 Apr 2019to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline
Who cannot join
- Ongoing CPAP treatment
- Psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Continuous Positive Airway Pressure (CPAP)
- Keywords
- CPAP
- Medical subject headings
- Sarcoidosis, Sleep Apnea, Obstructive, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP)Device
Also called positive airway pressure, positive pressure ventilation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous Positive Airway Pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start27 Apr 2019
- Primary completion15 May 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pier Valerio Mari, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Luca Richeldi, MD, PhD, Study director, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926832
- Sponsor's protocol ID
- 2455
- Acronym
- SARCOIDOSAS
- Status last verified
- Oct 2019
- First submitted
- 19 Apr 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Obstructive Sleep Apnea Syndrome in Sarcoidosis and Impact of CPAP Treatment on Associated Fatigue Status
- ClinicalTrials.gov ID
- NCT03926832
- Acronym / sponsor ID
- SARCOIDOSAS / 2455
- Conditions
- Sarcoidosis, Sleep Apnea, Obstructive, Fatigue
- Keywords
- CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 27 Apr 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Sarcoidosis | Experimental | Device: Continuous Positive Airway Pressure (CPAP)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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline
Key exclusion criteria (2 listed)
- Ongoing CPAP treatment
- Psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP)Also: positive airway pressure, positive pressure ventilationContinuous 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. | Device | Patients with Sarcoidosis |
Primary outcome
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.
5 secondary outcomes
Impact of Continuous Positive Airway Pressure (CPAP) treatment on fatigue associated status
Time frame: Day 1, month 3 of CPAP treatment
Impact of Continuous Positive Airway Pressure (CPAP) treatment on daytime sleepiness
Time frame: Day 1, month 3 of CPAP treatment
Compliance to CPAP treatment
Time frame: 3 month post CPAP treatment
Baseline evaluation of fatigue status
Time frame: Day 1
Baseline evaluation sleepiness
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Richeldi, MD, PhD study director
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure (CPAP) in people with Sarcoidosis and Sleep Apnea, Obstructive, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Obstructive Sleep Apnea (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.