Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement (OSASPI)
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|ClinicalTrials.gov Identifier: NCT02740569|
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment|
|Scleroderma, Systemic Sleep Apnea, Obstructive Pulmonary Disease||Other: No intervention|
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 Type :||Observational|
|Actual Enrollment :||62 participants|
|Official Title:||Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||October 1, 2016|
|Actual Study Completion Date :||October 1, 2016|
- Other: No intervention
Observational study. Intervention according to the clinical routines (not included in this part)
- 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
- Occurrence of pulmonary involvement based on computer tomography findings [ Time Frame: 6 months ]All patients will be evaluated within 6 months
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740569
|Istanbul, Pendik, Turkey|
|Principal Investigator:||Yuksel Peker, MD, Prof||Marmara University Medical School|