Implanted Phrenic Nerve Stimulator Database.

NCT03659019 | Recruiting

• 1 other identifier: NI17032J.
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

External Mechanical Ventilatory Support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of evolving episodes involving care, whether pathology events or intercurrent events

  10 years

Study Arms (2)

ventilatory paralysis

dependence on mechanical ventilatory support

Other: Quality of life questionnaires

central hypoventilation

documented permanent or nocturnal hypoventilation

Other: Quality of life questionnaires

Interventions

Quality of life questionnaires OTHER

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; ventilatory paralysis

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patient not affiliated to the social security system
• Patient unable to oppose his participation in research
• Patient not understanding French

Sponsors & Collaborators

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

Study Sites (1)

Thomas SIMILOWSKI

Paris, Île-de-France Region, 75013, France

RECRUITING

Central Study Contacts

Thomas SIMILOWSKI, PU-PH,MD,PhD

CONTACT

01 42 16 77 97; thomas.similowski@upmc.fr

Sophie LAVAULT, PhD

CONTACT

0142178196; sophie.lavault@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 6, 2018
• Study Start: November 20, 2018
• Primary Completion (Estimated): November 19, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 7, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)