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:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT00689234
Eligibility Criteria:
Inclusion Criteria:
* Uni- or bilateral diaphragmatic paralysis due to phrenic nerve paralysis present for at least 1 year
* With reduced VC, at least in supine position and no significant change in VC for at least 6 months
* At the time of randomisation symptomatic patient, defined by one of the following symptoms: not able to sleep in supine position or exertional dyspnoea
Exclusion Criteria:
* No informed consent obtained
* Other disease that may interfere with the evaluation of pulmonary function or the exercise capacity: COPD, parenchymal lung disease on the thoracic X-ray, documented ischemic heart disease or left heart failure, active rheumatological disease, severe orthopaedic problems,....
* Abnormal neuromuscular clinical investigation (apart from diaphragmatic dysfunction) and/or abnormal electromyography of the limbs compatible with generalized neuromuscular disease
* Known diseases resulting in abnormal blood coagulation
* Proven oncological origine of the phrenic nerve paralysis
* Age below 18 yrs old
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00689234
Study Brief:
Protocol Section:
NCT00689234