Scleroderma, SystemicOSASPINCT02740569
Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement
An observational study of Scleroderma, Systemic and Sleep Apnea, Obstructive, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. Obstructive sleep apnea (OSA) may also be seen in scleroderma. Less is known regarding the prevalence of OSA in scleroderma and its association with pulmonary involvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Systemic, Sleep Apnea, Obstructive, Pulmonary Disease
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2016to 1 Oct 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with known Scleroderma
Who may be able to join
- Known scleroderma diagnosis
- Must be able to give informed consent
Who cannot join
- Serious neurological and/or psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. Obstructive sleep apnea (OSA) may also be seen in scleroderma. Less is known regarding the prevalence of OSA in scleroderma and its association with pulmonary involvement.
Read the detailed description
Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. OSA may also be seen in scleroderma. Less is known regarding the prevalence of obstructive sleep apnea in scleroderma and its association with pulmonary involvement.
The investigators would like to address the prevalence of OSA in patients with Scleroderma, using overnight cardiorespiratory polygraphy. Other comorbidities and pulmonary findings on computer tomography (CT) as well as lung function tests will be evaluated.
The investigators plan to include 60 patients.
- Being tested
- No intervention
- Keywords
- scleroderma, sleep apnea, pulmonary disease
- Medical subject headings
- Scleroderma, Systemic, Sleep Apnea, Obstructive, Lung Diseases, Scleroderma, Diffuse, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study. Intervention according to the clinical routines (not included in this part)
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of OSA defined by apnea-hypopnea index (AHI) of at least 15/h on the overnight sleep study
All participants will be evaluated within 6 months
Measured: 6 months
Secondary outcomes (1)
Occurrence of pulmonary involvement based on computer tomography findings
All patients will be evaluated within 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion1 Oct 2016
- Study completion1 Oct 2016
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 Scleroderma, SystemicStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuksel Peker, MD, Prof, Principal investigator, Marmara University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740569
- Sponsor's protocol ID
- 09.2016.208
- Acronym
- OSASPI
- Status last verified
- Sep 2018
- First submitted
- 6 Apr 2016
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Yakut T, Balcan B, Karakurt S, Direskeneli H, Yalcinkaya Y, Peker Y. Impact of concomitant obstructive sleep apnea on pulmonary involvement and main pulmonary artery diameter in adults with scleroderma. Sleep Breath. 2021 Mar;25(1):135-143. doi: 10.1007/s11325-020-02059-4. Epub 2020 Apr 13.
PubMed 32285251
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement
- ClinicalTrials.gov ID
- NCT02740569
- Acronym / sponsor ID
- OSASPI / 09.2016.208
- Keywords
- scleroderma, sleep apnea, pulmonary disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 15 Apr 2016 (estimated)
- 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.
Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. Obstructive sleep apnea (OSA) may also be seen in scleroderma. Less is known regarding the prevalence of OSA in scleroderma and its association with pulmonary involvement.
Detailed description
Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. OSA may also be seen in scleroderma. Less is known regarding the prevalence of obstructive sleep apnea in scleroderma and its association with pulmonary involvement.
The investigators would like to address the prevalence of OSA in patients with Scleroderma, using overnight cardiorespiratory polygraphy. Other comorbidities and pulmonary findings on computer tomography (CT) as well as lung function tests will be evaluated.
The investigators plan to include 60 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with known Scleroderma
Key inclusion criteria (2 listed)
- Known scleroderma diagnosis
- Must be able to give informed consent
Key exclusion criteria (1 listed)
- Serious neurological and/or psychiatric disease
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 |
|---|---|---|
| No interventionObservational study. Intervention according to the clinical routines (not included in this part) | Other | – |
Primary outcome
Occurrence of OSA defined by apnea-hypopnea index (AHI) of at least 15/h on the overnight sleep study
Time frame: 6 months
All participants will be evaluated within 6 months
1 secondary outcome
Occurrence of pulmonary involvement based on computer tomography findings
Time frame: 6 months
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 7 Sep 2018.
- Derived from this study: PubMed 32285251Yakut T, Balcan B, Karakurt S, Direskeneli H, Yalcinkaya Y, Peker Y. Impact of concomitant obstructive sleep apnea on pulmonary involvement and main pulmonary artery diameter in adults with scleroderma. Sleep Breath. 2021 Mar;25(1):135-143. doi: 10.1007/s11325-020-02059-4. Epub 2020 Apr 13.
- Individual participant dataSharing planned: Undecided
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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.
Yuksel Peker, MD, Prof principal investigator
Marmara University Medical School
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 Scleroderma, Systemic and Sleep Apnea, Obstructive, run by Marmara University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 7 Sep 2018. 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 Turkey (Türkiye). 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?
Occurrence of OSA defined by apnea-hypopnea index (AHI) of at least 15/h on the overnight sleep study (time frame: 6 months). 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 NCT02740569, 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 7 Sep 2018.