External Mechanical Ventilatory SupportSPi-REGNCT03659019
Implanted Phrenic Nerve Stimulator Database.
An observational study of External Mechanical Ventilatory Support, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- External Mechanical Ventilatory Support
- What is being tested?
- Quality of life questionnaires
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2018to 31 Dec 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient not affiliated to the social security system
- Patient unable to oppose his participation in research
- Patient not understanding French
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Thomas SIMILOWSKI
Paris, Île-de-France Region, 75013
THOMAS SIMILOWSKI, PUPH, 01 42 16 77 97 ext. 0033, thomas.similowski@aphp.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- External Mechanical Ventilatory Support
- Being tested
- Quality of life questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnairesOther
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 group | Role | What they receive |
|---|---|---|
| ventilatory paralysis | dependence on mechanical ventilatory support Receives: Other: Quality of life questionnaires | |
| central hypoventilation | documented permanent or nocturnal hypoventilation Receives: Other: Quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Secondary outcomes (1)
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)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start20 Nov 2018
- Primary completion19 Nov 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for External Mechanical Ventilatory SupportStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Neuroresp, Reference centre Syndrome d'Ondine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659019
- Sponsor's protocol ID
- NI17032J.
- Acronym
- SPi-REG
- Status last verified
- Dec 2018
- First submitted
- 27 Aug 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Database of Patients Who Are Candidates for Implanted Phrenic Nerve Stimulator and Implanted Patients
- ClinicalTrials.gov ID
- NCT03659019
- Acronym / sponsor ID
- SPi-REG / NI17032J.
- Conditions
- External Mechanical Ventilatory Support
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Neuroresp, Reference centre Syndrome d'Ondine
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 19 Nov 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ventilatory paralysis | – | Other: Quality of life questionnairesdependence on mechanical ventilatory support |
| central hypoventilation | – | Other: Quality of life questionnairesdocumented permanent or nocturnal hypoventilation |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Patient not affiliated to the social security system
- Patient unable to oppose his participation in research
- Patient not understanding French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life questionnairesDuring 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. | Other | central hypoventilation, ventilatory paralysis |
Primary outcome
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
1 secondary outcome
Number of evolving episodes involving care, whether pathology events or intercurrent events
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of External Mechanical Ventilatory Support, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas SIMILOWSKI, PU-PH,MD,PhD (01 42 16 77 97 ext. 0033, thomas.similowski@upmc.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018.