Implanted Phrenic Nerve Stimulator Database. (SPi-REG)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: External Mechanical Ventilatory Support

Treatments: Other: Quality of life questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT03659019

NI17032J.

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No 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

Trial design

100 participants in 2 patient groups

ventilatory paralysis

Description:

dependence on mechanical ventilatory support

Treatment:

Other: Quality of life questionnaires

central hypoventilation

Description:

documented permanent or nocturnal hypoventilation

Treatment:

Other: Quality of life questionnaires