Implanted Phrenic Nerve Stimulator Database.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quality of life questionnaires.
- Who it may be relevant to
- Registry conditions: External Mechanical Ventilatory Support. Basic parameters: from 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Follow-up Database of Patients Who Are Candidates for Implanted Phrenic Nerve Stimulator and Implanted Patients
Overview
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.
Detailed description
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.
Interventions
- Other 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.
Primary outcome measures
- Score at the Medical Outcomes Study Short-Form General Health Survey (SF-12) scale in patients with implanted phrenic nerve stimulator [Time frame: 10 years]
Secondary outcome measures (1)
- Number of evolving episodes involving care, whether pathology events or intercurrent events [Time frame: 10 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Thomas SIMILOWSKI — Paris
Identifiers
NCT: NCT03659019 · NI17032J.