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NCT02740569 Clinical Trial

Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement

Sleep Apnea, Obstructive Clinical Trial

— OSASPI  

Official title:
Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02740569
Other study ID # 09.2016.208
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2016
Est. completion date October 1, 2016

Study information
Verified date September 2018
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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 information / eligibility
Status Completed
Enrollment 62
Est. completion date October 1, 2016
Est. primary completion date October 1, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Known scleroderma diagnosis

- Must be able to give informed consent

Exclusion Criteria:

- Serious neurological and/or psychiatric disease

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Turkey Marmara University Istanbul Pendik

Sponsors (1)
Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 6 months
Secondary Occurrence of pulmonary involvement based on computer tomography findings All patients will be evaluated within 6 months 6 months
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