NCT00213343

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

1 month

First QC Date

September 13, 2005

Last Update Submit

June 17, 2013

Conditions

Velopharyngeal Insufficiency

Keywords

aspirationphrenic nervemagnetic stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke patients

You may qualify if:

  • stroke with aspiration

You may not qualify if:

  • obstructive rhinitis bronchial obstruction pace maker phrenic nerve paralysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Velopharyngeal Insufficiency

Condition Hierarchy (Ancestors)

Mouth AbnormalitiesMouth DiseasesStomatognathic DiseasesPharyngeal DiseasesStomatognathic System AbnormalitiesOtorhinolaryngologic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • eric verin, MD -PHD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

May 1, 2005

Primary Completion

June 1, 2005

Study Completion

July 1, 2005

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

FR(1)