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Implanted Phrenic Nerve Stimulator Database.

NCT ID: NCT03659019

Last Updated: 2018-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-20

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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External Mechanical Ventilatory Support

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ventilatory paralysis

dependence on mechanical ventilatory support

Quality of life questionnaires

Intervention Type 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

documented permanent or nocturnal hypoventilation

Quality of life questionnaires

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neuroresp, Reference centre Syndrome d'Ondine

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Thomas SIMILOWSKI

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Thomas SIMILOWSKI, PU-PH,MD,PhD

Role: CONTACT

Phone: 01 42 16 77 97

Email: [email protected]

Sophie LAVAULT, PhD

Role: CONTACT

Phone: 0142178196

Email: [email protected]

Facility Contacts

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THOMAS SIMILOWSKI, PUPH

Role: primary

Other Identifiers

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NI17032J.

Identifier Type: -

Identifier Source: org_study_id