Implanted Phrenic Nerve Stimulator Database. (SPi-REG)

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

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.

Study Overview

• Status: Recruiting
• Conditions: External Mechanical Ventilatory Support
• Intervention / Treatment: Other: Quality of life questionnaires

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Sophie LAVAULT, PhD; Phone Number: 0033 0142178196; Email: sophie.lavault@aphp.fr
• Study Contact Backup: Name: Thomas SIMILOWSKI, PU-PH,MD,PhD; Phone Number: 0033 01 42 16 77 97; Email: thomas.similowski@upmc.fr

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75013
      • Recruiting
      • Thomas Similowski
      • Contact: THOMAS SIMILOWSKI, PUPH; Phone Number: 0033 01 42 16 77 97; Email: thomas.similowski@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients adressed to the Respiratory and Medical Resuscitation Unit of the Pitié-Salpêtrière Charles Foix Hospital Group for the search for an indication of SPi in the context of central ventilatory paralysis or central hypoventilation, whether or not the indication is retained at the end of the balance sheet; this population is essentially made up of adults, some but not all of whom benefit from a protection regime; it may occasionally include minors;

Patients addressed to the adult branch of the Rare Disease Reference Center for Congenital Central Venous Hypoventilation, located within the hospital group Pitié-Salpêtrière Charles Foix, for the assessment and monitoring of their disease. By definition, this population consists solely of adults.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ventilatory paralysis; dependence on mechanical ventilatory support	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.
central hypoventilation; documented permanent or nocturnal hypoventilation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score at the Medical Outcomes Study Short-Form General Health Survey (SF-12) scale in patients with implanted phrenic nerve stimulator	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	10 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Neuroresp, Reference centre Syndrome d'Ondine

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Anticipated): November 19, 2028
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: September 3, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NI17032J.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No