Evaluation of Executive Functions in Children With Cochleovestibular Deficit (Vestibulex)

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 Overview

• Status: Not yet recruiting
• Conditions: Hearing Loss; Cognitive Function; Executive Function; Vestibular Function
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Audrey MAUDOUX, MD; Phone Number: +331 40 03 24 49; Email: audrey.maudoux@aphp.fr
• Study Contact Backup: Name: Fabien BLANC, MD; Phone Number: +331 40 03 24 49; Email: blancfm@gmail.com

Study Locations

• France
  • Paris, France, 75019
    • Robert Debré Hospital
    • Contact: Audrey MAUDOUX, MD; Phone Number: +331 40 03 24 49; Email: audrey.maudoux@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children with vestibular dysfunction, with hearing loss or normal inner ear function

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function); Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: APHP220224; IDRCB: 2022-A00160-43 (Registry Identifier: French Health Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No