Transdiapragmatic pressure and contractile properties of the diaphragm following magnetic stimulation.
Jens Spiesshoefer, Carolin Henke, Simon Herkenrath...
https://pubmed.ncbi.nlm.nih.gov/31029769/Actively Recruiting
Led by RWTH Aachen University · Updated on 2026-01-28
800
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating the role of diaphragm function as a biomarker in patients with respiratory diseases such as Asthma, COPD, Fibrosis, and Pulmonary Hypertension. This study aims to better understand the causes of breathlessness dyspnea and how diaphragm dysfunction may relate to symptoms and disease outcomes. The research will include up to 800 patients from these four groups to explore the connection between respiratory muscle function and patient health. Participants will undergo comprehensive respiratory muscle testing, including diaphragm and intercostal muscle ultrasounds, lung function tests, exercise tolerance evaluations, and symptom questionnaires during one day at the study center. Follow-up will be conducted primarily by phone at 3, 6, 12, and 18 months after the initial visit. A smaller subgroup of patients starting certain approved drug therapies will have additional in-person follow-ups with repeated non-invasive measurements. Throughout the study, participants will complete various assessments such as dyspnea scales, walking tests, breathlessness ratings, and respiratory questionnaires. Researchers will also monitor hospitalizations and steroid use related to exacerbations to assess the prognostic significance of diaphragm dysfunction. The study includes detailed measurement of respiratory pressures, blood gas analysis, and electromyography, with participation lasting up to 18 months after enrollment.
CONDITIONS
Diaphragmatic Function as a Biomarker
J
Jens Spiesshoefer, MD
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RWTH Aachen University
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo comprehensive measurements of respiratory muscle function, lung function, exercise tolerance, and symptom burden during one day in the study lab.
1 baseline visit (in-person)
Duration - 18 months
Participants are followed up by phone at 3, 6, 12, and 18 months after the baseline visit to assess symptom progression and health outcomes. A small subset of participants initiating certain drug therapies will have in-person follow-up visits to repeat diagnostic measurements.
Phone follow-up at 3, 6, 12, and 18 months; in-person visits for a subset depending on therapy
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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Lead Sponsor