Evaluation of Executive Functions in Children With Cochleovestibular Deficit
Vestibulex
2 other identifiers
observational
60
1 country
1
Brief Summary
Vestibular system activity supports many functions ranging from gaze stabilization and postural control to high-level cortical functions involving spatial cognition, body perception, verticality perception, orientation, navigation, and spatial memory. Few studies have assessed the impact of a vestibular deficit on executive functions taking into account the simultaneous existence of sensorineural deafness in a child population. The BRIEF questionnaire (Behavioral Rating Inventory of Executive Function) allows a parental assessment of executive functions and is validated from the age of 5. Children were recruited from a pediatric population followed in the Ear Nose and Throat (ENT) department for audio-vestibular assessment and BRIEF questionnaire was completed by the accompanying parent.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2022
CompletedFirst Posted
Study publicly available on registry
December 27, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedDecember 27, 2022
November 1, 2022
1 year
December 16, 2022
December 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Global scores on the BRIEF (Behavioral Rating Inventory of Executive Function) questionnaire
Comparison of global scores obtained in children with vestibular dysfunction, with hearing loss or normal inner ear function
1 year
Study Arms (2)
children with vestibular dysfunction with hearing loss
children with vestibular dysfunction with hearing loss
children with vestibular dysfunction with normal inner ear function
children with vestibular dysfunction with normal inner ear function
Interventions
Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)
Eligibility Criteria
children with vestibular dysfunction, with hearing loss or normal inner ear function
You may qualify if:
- Patient aged ≥ 5 years \< 18 years with vestibulopathy confirmed during an ENT consultation
- Affiliated to the social security system
- Holders of parental authority and Patients informed and not opposed to participating in the research
- Mastery of the French language by patients and their parents
You may not qualify if:
- Refusal to participate
- Existence of another neurodevelopmental pathology or specific cognitive disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robert Debre Hospital
Paris, 75019, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Audrey MAUDOUX, MD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2022
First Posted
December 27, 2022
Study Start
January 1, 2023
Primary Completion
January 1, 2024
Study Completion
January 1, 2024
Last Updated
December 27, 2022
Record last verified: 2022-11