Velopharyngeal InsufficiencyNCT00213343
Effects of Phrenic Nerve Stimulation During Swallowing : Experimental Model of Aspiration
An observational study of Velopharyngeal Insufficiency, run by University Hospital, Rouen at 1 site in France.
Trial summary
the purpose of this study is to compare the oesophageal depression induced by bilateral phrenic nerve stimulation during swallowing in patients with neurological laryngeal aspiration Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Velopharyngeal Insufficiency
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- May 2005to Jul 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients
Who may be able to join
- stroke with aspiration
Who cannot join
- obstructive rhinitis bronchial obstruction pace maker phrenic nerve paralysis
Trial locations and contacts
1 site in 1 country.
About this study
the purpose of this study is to compare the oesophageal depression induced by bilateral phrenic nerve stimulation during swallowing in patients with neurological laryngeal aspiration
Read the detailed description
phrenic nerve stimulation during swallowing
- Conditions
- Velopharyngeal Insufficiency
- Keywords
- aspiration, phrenic nerve, magnetic stimulation
- Medical subject headings
- Velopharyngeal Insufficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionJun 2005
- Study completionJul 2005
Why it stopped: dyspnea
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Velopharyngeal InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- eric verin, MD -PHD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213343
- Sponsor's protocol ID
- 2002 /149/HP
- Status last verified
- Jun 2013
- First submitted
- 13 Sep 2005
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Phrenic Nerve Stimulation During Swallowing : Experimental Model of Aspiration
- ClinicalTrials.gov ID
- NCT00213343
- Acronym / sponsor ID
- 2002 /149/HP
- Conditions
- Velopharyngeal Insufficiency
- Keywords
- aspiration, phrenic nerve, magnetic stimulation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: dyspnea
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 21 Sep 2005 (estimated)
- 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.
the purpose of this study is to compare the oesophageal depression induced by bilateral phrenic nerve stimulation during swallowing in patients with neurological laryngeal aspiration
Detailed description
phrenic nerve stimulation during swallowing
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients
Key inclusion criteria (1 listed)
- stroke with aspiration
Key exclusion criteria (1 listed)
- obstructive rhinitis bronchial obstruction pace maker phrenic nerve paralysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: dyspnea). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
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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. This study is not recruiting at the moment.
eric verin, MD -PHD principal investigator
University Hospital, Rouen
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 Velopharyngeal Insufficiency, run by University Hospital, Rouen 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 1 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: stopped early, as of the sponsor's last update on 18 Jun 2013. 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?
The study was stopped early (reason given: dyspnea). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 18 Jun 2013.