SarcoidosisOSASANCT04156789
Obstructive Sleep Apnoea in Sarcoidosis
An observational study of Sarcoidosis and Obstructive Sleep Apnea, run by Malcolm Kohler at 1 site in Switzerland.
Trial summary
Sarcoidosis is a multisystemic granulomatous disease of unknown origin. Fatigue is a common problem in sarcoidosis affecting between 50% and 80% of patients, and thus represents a major impairment of their quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcoidosis, Obstructive Sleep Apnea, Fatigue
- What is being tested?
- Home sleep apnea testing
- How many people
- 149 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Oct 2019to 31 Oct 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sarcoidosis group: Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline vs Control group: matched control subjects without sarcoidosis
Who may be able to join
- Sarcoidosis group: Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline.
- Informed consent
- 18 years or above
- Control group: No sarcoidosis, no OSA
Who cannot join
- Moribund or severe disease prohibiting protocol adherence
- Continuous positive airway pressure treatment for OSA at baseline
- Use of oxygen therapy or home ventilation
- Physical or intellectual impairment precluding informed consent or protocol adherence
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obstructive Sleep Apnoea in Sarcoidosis: A Cross-sectional Observational Study
Sarcoidosis is a multisystemic granulomatous disease of unknown origin. Fatigue is a common problem in sarcoidosis affecting between 50% and 80% of patients, and thus represents a major impairment of their quality of life.
The findings of recent studies suggest a high prevalence of obstructive sleep apnoea (OSA) in patients with sarcoidosis, estimating a range from 17% to 67%. Pathomechanisms leading to this increased OSA prevalence are still unclear, yet likely to be multifactorial including sarcoid myopathy and neuropathy leading to impaired integrity of the upper airways as well as corticosteroid induced obesity.
Read more
While both diseases, Sarcoidosis and OSA, could lead to fatigue and excessive daytime sleepiness (EDS) the current managing strategies differ significantly. OSA patients are mostly treated with continuous positive airway pressure (CPAP) whereas sarcoidosis associated fatigue may require increased immunosuppressive therapy. Little is known about treatment of fatigue and sleepiness in patients suffering from both conditions.This study aims to close this knowledge gap and define prevalence of OSA in a swiss cohort with sarcoidosis patients.
Therefore, we plan a prospective, observational, controlled study to investigate the prevalence of sleepiness, fatigue, life quality and obstructive sleep apnoea in patients with Sarcoidosis.
Patients treated in the University Hospital Zurich due to sarcoidosis will be invited by letter to take part in this study. After confirmed consent and baseline assessments at the University Hospital Zurich, these patients will undergo a single night, in-home sleep study to assess possible OSA.
Sleepiness and fatigue specific questionnaires and in-home respiratory polygraphy (oRP) are obtained in all subjects. To assess inflammation status and other conditions connected to sleepiness like hypothyroidism and anaemia, sarcoidosis patients will undergo blood sampling.
- Conditions
- Sarcoidosis, Obstructive Sleep Apnea, Fatigue, Sleepiness
- Being tested
- Home sleep apnea testing
- Medical subject headings
- Sarcoidosis, Sleep Apnea, Obstructive, Fatigue, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home sleep apnea testingDiagnostic test
Sarcoidosis patients and control subjects will undergo one night of home sleep apnea testing using ApnoeaLinkTM Plus device (ResMed Corporation, Poway, Calif). The device records the patient's nasal respiratory pressure signal as a surrogate of nasal flow, respiratory movements by a thoracic impedance belt, and finger pulse oximetry. The results of the sleep study will be scored automatically with dedicated software (ResMed Corporation, Poway, Calif), and manually reviewed to ensure data accuracy.
| Study group | Role | What they receive |
|---|---|---|
| Sarcoidosis group | Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline Receives: Diagnostic Test: Home sleep apnea testing | |
| Control group | Control subjects have no sarcoidosis and will be sex, age (± 3 years), height (± 20 cm), and weight (± 15 kg) matched to sarcoidosis patients. Receives: Diagnostic Test: Home sleep apnea testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of OSA in sarcoidosis patients compared to matched controls
Conventional thresholds according to the American Academy of Sleep Medicine Task Force of AHI ≥5, ≥15 and ≥30 will be used to define mild, moderate and severe OSA respectively. OSA prevalence will be compared between both groups.
Measured: through one sleep study night
Secondary outcomes (15)
Apnoea-Hypopnea Index (AHI)
AHI will be compared between both groups.
Measured: through one sleep study night
Fatigue Severity Scale (FAS)
FAS will be compared between both groups. Score ranges from 10 to 50 points with 50 points presenting the most severe form of fatigue.
Measured: one day
Blood pressure
Blood pressure will be compared between both groups.
Measured: one day
Lung function test
Lung function tests will be compared between both groups.
Measured: one day
Puls wave analysis
Applanation-derived augmentation index (AIx) will be compared between both groups.
Measured: one day
Interleukin-2 blood levels
Association between Interleukin-2 blood levels and OSA severity (AHI) and excessive daytime sleepiness (ESS) in sarcoidosis will be assessed.
Measured: one day
Oxygen-Desaturation Index (ODI)
ODI will be compared between both groups.
Measured: through one sleep study night
Epworth Sleepiness Scale (ESS)
ESS will be compared between both groups. The test measures subjective sleepiness. The scale ranges from 0 to 24 points. More points indicate higher sleepiness.
Measured: one day
Functional outcomes of sleep questionnaire (FOSQ)
FOSQ will be compared between both groups. The score ranges from 5 to 20 points. Higher scores indicate better functional status.
Measured: one day
Short-form-36 (SF-36)
SF-36 will be compared between both groups. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: one day
Patient Health Questionnaire (PHQ) Module 9
PHQ 9 will be compared between both groups. The test results range between 0 and 27 points. Higher scores indicate severe forms of depression.
Measured: one day
NoSAS-Score
NoSAS-Score will be compared between both groups. The score ranges from 0-17 points. The patient has a high probability of sleep disordered breathing if he has a NoSAS-Score of 8 or higher.
Measured: one day
Heart rate
Heart rate will be compared between both groups
Measured: one day
Neopterin blood level
Association between Neopterin blood levels and OSA severity (AHI) and excessive daytime sleepiness (ESS) in sarcoidosis will be assessed.
Measured: one day
C-reactive protein (CRP) blood levels
Association between CRP blood levels and OSA severity (AHI) and excessive daytime sleepiness (ESS) in sarcoidosis will be assessed.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start28 Oct 2019
- Primary completion31 Aug 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malcolm Kohler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Malcolm Kohler, University of Zurich
- Investigators
- Malcolm Kohler, Prof, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156789
- Sponsor's protocol ID
- 2019-01604
- Other IDs
- 2019
- Acronym
- OSASA
- Status last verified
- Jan 2022
- First submitted
- 30 Oct 2019
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roeder M, Sievi NA, Schneider A, Osswald M, Malesevic S, Kolios A, Nilsson J, Kohler M, Franzen D. The prevalence of obstructive sleep apnea in sarcoidosis and its impact on sleepiness, fatigue, and sleep-associated quality of life: a cross-sectional study with matched controls (the OSASA study). J Clin Sleep Med. 2022 Oct 1;18(10):2415-2422. doi: 10.5664/jcsm.10140.
PubMed 35855534
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnoea in Sarcoidosis: A Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT04156789
- Acronym / sponsor ID
- OSASA / 2019-01604
- Conditions
- Sarcoidosis, Obstructive Sleep Apnea, Fatigue, Sleepiness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Malcolm KohlerUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 8 Nov 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 of unknown origin. Fatigue is a common problem in sarcoidosis affecting between 50% and 80% of patients, and thus represents a major impairment of their quality of life.
The findings of recent studies suggest a high prevalence of obstructive sleep apnoea (OSA) in patients with sarcoidosis, estimating a range from 17% to 67%. Pathomechanisms leading to this increased OSA prevalence are still unclear, yet likely to be multifactorial including sarcoid myopathy and neuropathy leading to impaired integrity of the upper airways as well as corticosteroid induced obesity.
While both diseases, Sarcoidosis and OSA, could lead to fatigue and excessive daytime sleepiness (EDS) the current managing strategies differ significantly. OSA patients are mostly treated with continuous positive airway pressure (CPAP) whereas sarcoidosis associated fatigue may require increased immunosuppressive therapy. Little is known about treatment of fatigue and sleepiness in patients suffering from both conditions.This study aims to close this knowledge gap and define prevalence of OSA in a swiss cohort with sarcoidosis patients.
Therefore, we plan a prospective, observational, controlled study to investigate the prevalence of sleepiness, fatigue, life quality and obstructive sleep apnoea in patients with Sarcoidosis.
Patients treated in the University Hospital Zurich due to sarcoidosis will be invited by letter to take part in this study. After confirmed consent and baseline assessments at the University Hospital Zurich, these patients will undergo a single night, in-home sleep study to assess possible OSA.
Sleepiness and fatigue specific questionnaires and in-home respiratory polygraphy (oRP) are obtained in all subjects. To assess inflammation status and other conditions connected to sleepiness like hypothyroidism and anaemia, sarcoidosis patients will undergo blood sampling.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcoidosis group | – | Diagnostic Test: Home sleep apnea testingSubjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline |
| Control group | – | Diagnostic Test: Home sleep apnea testingControl subjects have no sarcoidosis and will be sex, age (± 3 years), height (± 20 cm), and weight (± 15 kg) matched to sarcoidosis patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sarcoidosis group: Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline vs Control group: matched control subjects without sarcoidosis
Key inclusion criteria (4 listed)
- Sarcoidosis group: Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline.
- Informed consent
- 18 years or above
- Control group: No sarcoidosis, no OSA
Key exclusion criteria (5 listed)
- Moribund or severe disease prohibiting protocol adherence
- Continuous positive airway pressure treatment for OSA at baseline
- Use of oxygen therapy or home ventilation
- Physical or intellectual impairment precluding informed consent or protocol adherence
- Pregnant patients
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 |
|---|---|---|
| Home sleep apnea testingSarcoidosis patients and control subjects will undergo one night of home sleep apnea testing using ApnoeaLinkTM Plus device (ResMed Corporation, Poway, Calif). The device records the patient's nasal respiratory pressure signal as a surrogate of nasal flow, respiratory movements by a thoracic impedance belt, and finger pulse oximetry. The results of the sleep study will be scored automatically with dedicated software (ResMed Corporation, Poway, Calif), and manually reviewed to ensure data accuracy. | Diagnostic test | Control group, Sarcoidosis group |
Primary outcome
Prevalence of OSA in sarcoidosis patients compared to matched controls
Time frame: through one sleep study night
Conventional thresholds according to the American Academy of Sleep Medicine Task Force of AHI ≥5, ≥15 and ≥30 will be used to define mild, moderate and severe OSA respectively. OSA prevalence will be compared between both groups.
15 secondary outcomes
Apnoea-Hypopnea Index (AHI)
Time frame: through one sleep study night
Fatigue Severity Scale (FAS)
Time frame: one day
Blood pressure
Time frame: one day
Lung function test
Time frame: one day
Puls wave analysis
Time frame: one day
Interleukin-2 blood levels
Time frame: one day
Oxygen-Desaturation Index (ODI)
Time frame: through one sleep study night
Epworth Sleepiness Scale (ESS)
Time frame: one day
Functional outcomes of sleep questionnaire (FOSQ)
Time frame: one day
Short-form-36 (SF-36)
Time frame: one day
Patient Health Questionnaire (PHQ) Module 9
Time frame: one day
NoSAS-Score
Time frame: one day
Heart rate
Time frame: one day
Neopterin blood level
Time frame: one day
C-reactive protein (CRP) blood levels
Time frame: one day
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 14 Jan 2022.
- Derived from this study: PubMed 35855534Roeder M, Sievi NA, Schneider A, Osswald M, Malesevic S, Kolios A, Nilsson J, Kohler M, Franzen D. The prevalence of obstructive sleep apnea in sarcoidosis and its impact on sleepiness, fatigue, and sleep-associated quality of life: a cross-sectional study with matched controls (the OSASA study). J Clin Sleep Med. 2022 Oct 1;18(10):2415-2422. doi: 10.5664/jcsm.10140.
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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.
Malcolm Kohler, Prof principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis and Obstructive Sleep Apnea, run by Malcolm Kohler at 1 site in Switzerland.
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 4 inclusion and 5 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 14 Jan 2022. 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 Switzerland. 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 OSA in sarcoidosis patients compared to matched controls (time frame: through one sleep study night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04156789, which also lists 1 linked publication.
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 14 Jan 2022.