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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
Sponsor:
Information provided by (Responsible Party):
Marmara University

Study Description
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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.

Condition or disease Intervention/treatment
Scleroderma, Systemic Sleep Apnea, Obstructive Pulmonary Disease Other: No intervention

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
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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: No intervention
    Observational study. Intervention according to the clinical routines (not included in this part)

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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
Blood samples for metabolic and cardiovascular markers

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients with known Scleroderma
Criteria

Inclusion Criteria:

  • Known scleroderma diagnosis
  • Must be able to give informed consent

Exclusion Criteria:

  • Serious neurological and/or psychiatric disease
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Turkey
Marmara University
Istanbul, Pendik, Turkey
Sponsors and Collaborators
Marmara University
Investigators
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Principal Investigator: Yuksel Peker, MD, Prof Marmara University Medical School
More Information
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Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT02740569    
Other Study ID Numbers: 09.2016.208
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Marmara University:
scleroderma
sleep apnea
pulmonary disease
Additional relevant MeSH terms:
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Lung Diseases
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Respiratory Tract Diseases
 Respiration Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases