Vestibulex: Evaluation of Executive Functions in Children With Cochleovestibular Deficit

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05665907
Collaborator
(none)
60
1
12
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Executive Functions in Children With Cochleovestibular Deficit
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
children with vestibular dysfunction with hearing loss

children with vestibular dysfunction with hearing loss

Other: Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)
Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)

children with vestibular dysfunction with normal inner ear function

children with vestibular dysfunction with normal inner ear function

Other: Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)
Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)

Outcome Measures

Primary Outcome Measures

  1. Global scores on the BRIEF (Behavioral Rating Inventory of Executive Function) questionnaire [1 year]

    Comparison of global scores obtained in children with vestibular dysfunction, with hearing loss or normal inner ear function

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 18 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • Refusal to participate

  • Existence of another neurodevelopmental pathology or specific cognitive disorder

Contacts and Locations

Locations

Site City State Country Postal Code
1 Robert Debre Hospital Paris France 75019

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Audrey MAUDOUX, MD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT05665907
Other Study ID Numbers:
  • APHP220224
  • IDRCB: 2022-A00160-43
First Posted:
Dec 27, 2022
Last Update Posted:
Dec 27, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 27, 2022