Implanted Phrenic Nerve Stimulator Database.

NCT03659019 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Observational

Started

2018-11-20

Last updated

2018-12-07

Condition(s) studied

External Mechanical Ventilatory Support

Investigational drug(s) / intervention(s)

Quality of life questionnaires

Quality of life questionnaires: During 10 years, the study will be conduct to obtain the quality of life evolution and medical complications in patients candidates but not implanted, and in patients candidates then implanted with the phrenic nerve stimulator.

Study summary

Phrenic nerve stimulation is a neurostimulation technique that allows patients who are dependent on external mechanical ventilatory support to regain their breathing autonomy. This study aim at long term following of patients who may be candidates for permanent implanted phrenic nerve stimulator.

Eligibility

Sex

ALL

Min age

5 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Score at the Medical Outcomes Study Short-Form General Health Survey (SF-12) scale in patients with implanted phrenic nerve stimulator — 10 years
Evolution of the physical (score between 9.95 and 70.02) and mental (score between 5.89 and 71.97) dimensions included into the SF-12 scale in patients with implanted phrenic nerve stimulator before, and up to 10 years after the implantation

Trial sites (1)

Facility	City	Region	Status
Thomas SIMILOWSKI	Paris	Île-de-France Region	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03659019 on ClinicalTrials.gov ↗ ← All trials in France