Implanted Phrenic Nerve Stimulator Database.

Follow-up Database of Patients Who Are Candidates for Implanted Phrenic Nerve Stimulator and Implanted Patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03659019

Acronym

SPi-REG

Enrollment

100

Registered

2018-09-06

Start date

2018-11-20

Completion date

2028-12-31

Last updated

2018-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

External Mechanical Ventilatory Support

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.

Interventions

OTHERQuality of life questionnaires

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

France

Contacts

Primary ContactThomas SIMILOWSKI, PU-PH,MD,PhD

thomas.similowski@upmc.fr01 42 16 77 97

Backup ContactSophie LAVAULT, PhD

sophie.lavault@aphp.fr0142178196

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026