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Implanted Phrenic Nerve Stimulator Database. (SPi-REG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03659019
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
Neuroresp, Reference centre Syndrome d'Ondine
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment
External Mechanical Ventilatory Support 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Follow-up Database of Patients Who Are Candidates for Implanted Phrenic Nerve Stimulator and Implanted Patients
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : November 19, 2028
Estimated Study Completion Date : December 31, 2028
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Score at the Medical Outcomes Study Short-Form General Health Survey (SF-12) scale in patients with implanted phrenic nerve stimulator [ Time Frame: 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 Outcome Measures :
  1. Number of evolving episodes involving care, whether pathology events or intercurrent events [ Time Frame: 10 years ]
    Follow-up of complications in implanted patients compared with the natural course of the disease (i.e. non-implanted patients)


Eligibility Criteria
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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659019


Contacts
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Contact: Thomas SIMILOWSKI, PU-PH,MD,PhD 01 42 16 77 97 ext 0033 thomas.similowski@upmc.fr
Contact: Sophie LAVAULT, PhD 0142178196 ext 0033 sophie.lavault@aphp.fr

Locations
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France
Thomas SIMILOWSKI Recruiting
Paris, Ile De France, France, 75013
Contact: THOMAS SIMILOWSKI, PUPH    01 42 16 77 97 ext 0033    thomas.similowski@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Neuroresp, Reference centre Syndrome d'Ondine
More Information
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Additional Information:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03659019    
Other Study ID Numbers: NI17032J.
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No