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Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement

Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02740569
Acronym
OSASPI
Enrollment
62
Registered
2016-04-15
Start date
2016-04-30
Completion date
2016-10-01
Last updated
2018-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Scleroderma, Systemic, Sleep Apnea, Obstructive

Keywords

scleroderma, sleep apnea, pulmonary disease

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.

Interventions

OTHERNo intervention

Observational study. Intervention according to the clinical routines (not included in this part)

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Serious neurological and/or psychiatric disease

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of OSA defined by apnea-hypopnea index (AHI) of at least 15/h on the overnight sleep study6 monthsAll participants will be evaluated within 6 months

Secondary

MeasureTime frameDescription
Occurrence of pulmonary involvement based on computer tomography findings6 monthsAll patients will be evaluated within 6 months

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026