Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT04563468
Eligibility Criteria:
Inclusion Criteria for UDP patients:
* Stable, symptomatic adult UDP patients (age ≥18 yrs)
* UDP due to presumed neuralgic amyotrophy
* UDP after surgery/anesthesia (as long as there is no trauma/complete section of the phrenic nerves)
* idiopathic UDP
* UDP patients with Baseline Dyspnea Index (BDI) equal or lower than 9 out of 12.
* UDP patients who have reduced Pi,max (\<70% of predicted normal value), reduced vital capacity (\<75% predicted normal value in sitting and more than 15% reduction when performed supine compared to sitting).
Exclusion Criteria for UDP patients:
* underlying cardiac or respiratory disease that explains symptoms of dyspnea
* malignancy (i.e. metastatic lung cancer)
* diagnosed psychiatric or cognitive disorders
* concomitant progressive neurological, neuromuscular, or vestibular disorders
* severe orthopedic problems that have a major impact on performance of functional tests
Healthy adult (age ≥18 yrs) control subjects:
\- recruitement via two methods. First, friends and family of the MSc student involved in this project will be asked to participate. Secondly, posters with information about the study will be displayed in the University hospital Leuven.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04563468
Study Brief:
Protocol Section:
NCT04563468