Long-term follow-up of patients with implanted phrenic nerve stimulators
Follow-up Database of Patients Who Are Candidates for Implanted Phrenic Nerve Stimulator and Implanted Patients
This study looks at how living with a phrenic nerve stimulator affects the quality of life and health of people with breathing problems over ten years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT03659019 on ClinicalTrials.gov |
What this trial studies
This observational study aims to track the long-term quality of life and medical complications in patients who are candidates for a permanent implanted phrenic nerve stimulator. It focuses on individuals with central respiratory paralysis or congenital central hypoventilation who are dependent on external mechanical ventilatory support. Over a period of 10 years, the study will collect data through quality of life questionnaires to assess the impact of the phrenic nerve stimulation technique. The study will include both patients who have been implanted with the device and those who are candidates but have not yet received it.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with central respiratory paralysis or congenital central hypoventilation who require mechanical ventilatory support.
Not a fit: Patients who are not affiliated with the social security system or who cannot understand French may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve the quality of life for patients with respiratory paralysis by providing insights into the effectiveness of phrenic nerve stimulation.
How similar studies have performed: While this approach is relatively novel, similar studies on neurostimulation techniques have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with central respiratory paralysis (medullary lesions or supramedullary lesions, whatever their causes) or patients with congenital central hypoventilation (including Ondine syndrome by Phox2B mutation) or acquired (whatever the cause), with permanent hypoventilation or related to sleep. Exclusion Criteria: * Patient not affiliated to the social security system * Patient unable to oppose his participation in research * Patient not understanding French
Where this trial is running
Paris, Île-de-France Region
- Thomas SIMILOWSKI — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Study coordinator: Thomas SIMILOWSKI, PU-PH,MD,PhD
- Email: thomas.similowski@upmc.fr
- Phone: 01 42 16 77 97
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.