Utility of Breath-holding Test in Systemic Sclerosis
- Conditions
- Systemic Sclerosis
- Interventions
- Other: scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWT
- Registration Number
- NCT04484948
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
This study aims to evaluate the utility of breath-holding test as a marker of pulmonary disease severity in patients with systemic sclerosis.
- Detailed Description
Systemic sclerosis (SSc) is a chronic autoimmune disease of unknown etiology with high morbidity and mortality. SSc manifests by fibrosis of skin and internal organs. Although the underlying mechanisms are still subject to investigation, endothelial dysfunction and abnormal immune response are thought to contribute to vascular dysfunction and fibrosis in SSc.
Pulmonary involvement, such as pulmonary arterial hypertension (PAH) and interstitial lung disease (ILD) is a major cause of death in SSc. Although the 6MWT is generally used for evaluating PAH and ILD, the utility in SSc is undetermined. Several investigators have found weak or moderate correlations of 6MWT in pulmonary involvement in SSc. The 6MWT is influenced by the status of all organ systems involved in exercise (pulmonary, cardiac, peripheral vascular, neuromuscular unit and muscle metabolism) as well as by specifics of test conditions. There is a pressing need for new, practical method which corroborates the current 6MWT for the evaluation of pulmonary disease severity in SSc.
Breath-holding test (BHT) is one of the most useful methods for assessing the sensitivity of peripheral chemoreflex. Recent studies have demonstrated that BHT was correlated to pulmonary function test. BHT can be safely conducted and doctors handle a medical emergency during test easily as well. Therefore, this study evaluates the utility of BHT as surrogate marker of pulmonary involvement in patients with SSc.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- A diagnosis of systemic sclerosis according to 2013 ACR/EULAR criteria
- Must understand and voluntarily sign an informed consent form including writing consent for data protection
- The resting oxygen saturation by pulse oximetry < 90% in room air
- Unstable angina or myocardial infarction during the previous month
- Patients considered unable to the breath-holding test or 6 minute walk test
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Systemic sclerosis group scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWT Systemic sclerosis diagnosis according to 2013 American College of Rheumatology(ACR)/European League Against Rheumatism(EULAR) classification criteria
- Primary Outcome Measures
Name Time Method Correlation of breath-holding test with Borg Dyspnea Index Day 1 at inclusion Borg Scale on a 0-10 point
- Secondary Outcome Measures
Name Time Method Correlation of breath-holding time with pulmonary function indices Day 1 at inclusion Pulmonary function indices including FVC (%) and DLCO (%)
Correlation of breath-holding time with data on the echocardiography Day 1 at inclusion Echocardiography including left ventricular ejection fraction and pulmonary arterial systolic pressure (mmHg)
Correlation of breath-holding time with scleroderma health assessment questionnaire (SHAQ) Day 1 at inclusion SHAQ ranging from 0 to 3
Correlation of breath-holding time with 6 minute walk test (6MWT) distance Day 1 at inclusion 6MWT distance measured in meters according to American Thoracic Society guidelines
Correlation of breath-holding time with oxygen saturation during 6MWT Day 1 at inclusion Oxygen saturation monitored by wearable pulse oximeter (Radius PPG™ Tetherless Pulse Oximetry, Masimo Corp., Irvine, CA, USA)
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of