CClinicalTrials.gg
Status unknownNCT05665907VestibulexUpdated Dec 27, 2022

Evaluation of Executive Functions in Children With Cochleovestibular Deficit

An observational study in Vestibular Function, Hearing Loss and Cognitive Function, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-12-27.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
5 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Vestibular Function
  • Hearing Loss
  • Cognitive Function
  • Executive Function

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03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's planned enrollment of 60 is below the median of 87 across 270 observational studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Refusal to participate
  • Existence of another neurodevelopmental pathology or specific cognitive disorder
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • children with vestibular dysfunction with hearing loss

    children with vestibular dysfunction with hearing loss

    Other: 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)

Interventions

  • OtherQuestionnaire BRIEF (Behavioral Rating Inventory of Executive Function)

    Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)

06

What researchers measure

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

    Time frame: 1 year

07

Study locations

1 site
  • Robert Debre Hospital
    Paris, 75019, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05665907
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Dec 27, 2022
Start date
Jan 1, 2023 (estimated)
Primary completion
Jan 1, 2024 (estimated)
Completion
Jan 1, 2024 (estimated)
Last update
Dec 27, 2022

Study contacts

Audrey MAUDOUX, MD
Contact
audrey.maudoux@aphp.fr
+331 40 03 24 49
Fabien BLANC, MD
Contact
blancfm@gmail.com
+331 40 03 24 49
Audrey MAUDOUX, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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