Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement

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.

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Key information

Conditions

Scleroderma, Systemic Apnea Connective Tissue Diseases Dyssomnias Lung Diseases Nervous System Diseases Pulmonary Disease Respiration Disorders Respiratory Tract Diseases Scleroderma, Diffuse Skin Diseases Skin and Connective Tissue Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University

Istanbul, Pendik, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Known scleroderma diagnosis
Must be able to give informed consent

Exclusion criteria

Serious neurological and/or psychiatric disease

Treatment and study plan

No intervention

Other

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

Primary outcomes

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 outcomes

Occurrence of pulmonary involvement based on computer tomography findings

Time frame: 6 months

All patients will be evaluated within 6 months

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Acronym: OSASPI

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Apr 15, 2016
Registry last updated: Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed