Implanted Phrenic Nerve Stimulator Database.

Recruiting

• Conditions: External Mechanical Ventilatory Support
• Interventions: Other: Quality of life questionnaires

• Registration Number: NCT03659019
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

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.

Study Timeline

• Study First Submitted: 2018-08-27
• Study First Submitted QC: 2018-09-03
• Study First Posted: 2018-09-06
• Study Start: 2018-11-20
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-06
• Last Update Posted: 2018-12-07
• Primary Completion: 2028-11-19
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ventilatory paralysis	Quality of life questionnaires	dependence on mechanical ventilatory support
central hypoventilation	Quality of life questionnaires	documented permanent or nocturnal hypoventilation

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Number of evolving episodes involving care, whether pathology events or intercurrent events	10 years	Follow-up of complications in implanted patients compared with the natural course of the disease (i.e. non-implanted patients)

Trial Locations

Locations (1)

Thomas SIMILOWSKI; 🇫🇷 Paris, Ile De France, France