Sleep Apnea, Obstructive Clinical Trial
— OSASPIOfficial title:
Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement
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 |
Verified date | September 2018 |
Source | Marmara University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Marmara University | Istanbul | Pendik |
Lead Sponsor | Collaborator |
---|---|
Marmara University |
Turkey,
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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