Vestibular FunctionVestibulexNCT05665907
Evaluation of Executive Functions in Children With Cochleovestibular Deficit
An observational study of Vestibular Function and Hearing Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Vestibular Function, Hearing Loss, Cognitive Function
- What is being tested?
- Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Child, Adult
Study population: children with vestibular dysfunction, with hearing loss or normal inner ear function
Who may be able to join
- 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
Who cannot join
- Refusal to participate
- Existence of another neurodevelopmental pathology or specific cognitive disorder
Trial locations and contacts
1 site in 1 country.
France1 site
Robert Debre Hospital
Paris, 75019
Audrey MAUDOUX, MD, +331 40 03 24 49, audrey.maudoux@aphp.fr
About this study
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.
- Being tested
- Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)Other
Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)
| Study group | Role | What they receive |
|---|---|---|
| children with vestibular dysfunction with hearing loss | children with vestibular dysfunction with hearing loss Receives: 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 Receives: Other: Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular FunctionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey MAUDOUX, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665907
- Sponsor's protocol ID
- APHP220224
- Other IDs
- IDRCB: 2022-A00160-43
- Acronym
- Vestibulex
- Status last verified
- Nov 2022
- First submitted
- 16 Dec 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Executive Functions in Children With Cochleovestibular Deficit
- ClinicalTrials.gov ID
- NCT05665907
- Acronym / sponsor ID
- Vestibulex / APHP220224
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with vestibular dysfunction with hearing loss | – | Other: Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)children with vestibular dysfunction with hearing loss |
| children with vestibular dysfunction with normal inner ear function | – | Other: Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)children with vestibular dysfunction with normal inner ear function |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- children with vestibular dysfunction, with hearing loss or normal inner ear function
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Refusal to participate
- Existence of another neurodevelopmental pathology or specific cognitive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function)Questionnaire BRIEF (Behavioral Rating Inventory of Executive Function) | Other | children with vestibular dysfunction with hearing loss, children with vestibular dysfunction with normal inner ear function |
Primary outcome
Global scores on the BRIEF (Behavioral Rating Inventory of Executive Function) questionnaire
Time frame: 1 year
Comparison of global scores obtained in children with vestibular dysfunction, with hearing loss or normal inner ear function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey MAUDOUX, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Function and Hearing Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Audrey MAUDOUX, MD (+331 40 03 24 49, audrey.maudoux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global scores on the BRIEF (Behavioral Rating Inventory of Executive Function) questionnaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.