Assessing diaphragm function in patients with respiratory diseases
Diaphragmatic Function as a Biomarker in Patients With Respiratory Diseases
This study is testing how well the diaphragm works in people with respiratory diseases to see if it affects their breathing difficulties and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RWTH Aachen University Academic / other |
| Drugs / interventions | Dupilumab |
| Locations | 1 site (Aachen, North Rhine-Westphalia) |
| Trial ID | NCT05903001 on ClinicalTrials.gov |
What this trial studies
This observational study aims to measure respiratory muscle function and strength in patients suffering from respiratory diseases such as asthma, COPD, fibrosis, and pulmonary hypertension. The researchers will recruit 800 patients and evaluate diaphragm and accessory muscle function, lung function, exercise tolerance, and symptom burden in a lab setting. Participants will be followed up via phone at 3, 6, 12, and 18 months to assess the relationship between diaphragm function and dyspnea, as well as the prognostic significance of diaphragm dysfunction in predicting hospitalizations and steroid use.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of COPD, asthma, pulmonary fibrosis, or pulmonary hypertension.
Not a fit: Patients with a BMI over 35 or those with conditions that could interfere with the study's evaluations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into diaphragm function as a potential biomarker for managing respiratory diseases and improving patient outcomes.
How similar studies have performed: While diaphragm function has been studied in various contexts, this specific approach to assessing its prognostic significance in respiratory diseases is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patient has one of the following lung diseases: COPD, bronchial asthma, pulmonary fibrosis, pulmonary hypertension * is 18 years or older * is mentally and physically able to understand the study and to follow instructions * are legally competent * signed declaration of consent Exclusion Criteria: * BMI \> 35 * current or treatments or diseases in the past which could influence the evaluation of the study * Expected lack of willingness to actively participate in study-related measures * alcohol or drug abuse * disc herniation/prolapse * epilepsy * wheelchair bound * in custody due to an official or court order * in a dependent relationship or employment relationship with investigating physician or one of their deputy * emergency inpatient hospital stay within 4 weeks before study-specific examinations
Where this trial is running
Aachen, North Rhine-Westphalia
- RWTH Aachen University Hospital — Aachen, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Jens Spiesshoefer, MD — Uniklinik RWTH Aachen
- Study coordinator: Jens Spiesshoefer, MD
- Email: jspiesshoefer@ukaachen.de
- Phone: 0049 2418037036
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.