NCT05665907

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 16, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

December 27, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

December 16, 2022

Last Update Submit

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

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

Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)

children with vestibular dysfunction with hearing losschildren with vestibular dysfunction with normal inner ear function

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Audrey MAUDOUX, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabien BLANC, MD

CONTACT

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

Locations