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Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement

Completed
Conditions
Pulmonary Disease
Scleroderma, Systemic
Sleep Apnea, Obstructive
Registration Number
NCT02740569
Lead Sponsor
Marmara University
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
62
Inclusion Criteria
  • Known scleroderma diagnosis
  • Must be able to give informed consent
Exclusion Criteria
  • Serious neurological and/or psychiatric disease

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Occurrence of OSA defined by apnea-hypopnea index (AHI) of at least 15/h on the overnight sleep study6 months

All participants will be evaluated within 6 months

Secondary Outcome Measures
NameTimeMethod
Occurrence of pulmonary involvement based on computer tomography findings6 months

All patients will be evaluated within 6 months

Trial Locations

Locations (1)

Marmara University

🇹🇷

Istanbul, Pendik, Turkey

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