AzTrials
AzTrials

Vestibular DysfunctionIVANSNCT06909266

Impact of Vestibular Function on Deaf Infants' Activities of Daily Living

An observational study of Vestibular Dysfunction and Hearing Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This non-interventional study aims to assess the impact of vestibular impairments on the daily life activities of deaf children aged 0 to 2 years old. Three groups of participants will be included: deaf children with vestibular impairment, deaf children without vestibular impairment, and hearing children without… Read more about this study

Who is it for?
Ages 1 day to 2 years
What is being tested?
OT Hope 0 - 5 ans Therapeutic tool and Qualitative interviews with parents
How many people
105 participants
Where
1 siteFrance
Study dates
27 Mar 2025to 1 Apr 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 1 day to 2 years
  • All sexes
  • Child

Study population: Children coming in consultations in the ENT department

Who may be able to join

  • Group 1: Deaf children with confirmed vestibular impairment.
  • Group 2: Deaf children without vestibular impairment.
  • Group 3: Hearing children without vestibular impairment (control group).

Who cannot join

  • Presence of neuromotor or orthopedic disorders.
  • Presence of pervasive developmental disorders that could interfere with daily activity assessments.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Audrey MAUDOUX, MD contact

+33140032449

audrey.maudoux@aphp.fr

Amandine TISSIER, MD contact

+33140032449

amandine_tissier@hotmail.fr

France1 site, 1 recruiting
  • Robert Debré Hospital

    Paris, 75019

    Audrey MAUDOUX, MD, +33140032449, audrey.maudoux@aphp.fr

    Amandine TISSIER, 0140032449, amandine_tissier@hotmail.fr

    Recruiting

Other trials in France

About this study

This non-interventional study aims to assess the impact of vestibular impairments on the daily life activities of deaf children aged 0 to 2 years old. Three groups of participants will be included: deaf children with vestibular impairment, deaf children without vestibular impairment, and hearing children without vestibular dysfunction (control group).

Children's daily activities will be evaluated through the OT Hope 0-5 years tool, a parent-administered questionnaire designed to measure competencies in different areas: personal care, play, and social interactions. This study also includes qualitative interviews with parents to further explore how vestibular impairments affect children's daily routines.

Read more

It is hypothesized that:

  • Deaf children with vestibular impairments will show lower scores in daily life activities compared to the other two groups.
  • Deaf children without vestibular impairments will demonstrate scores closer to those of hearing children but may show some differences due to their hearing status.

The research is conducted at the Robert Debré Hospital, in Paris, and aims to enroll 105 children over a three-year period. The data collected will provide insights into the specific needs of children with vestibular impairments and lay the groundwork for targeted early interventions.

Read the detailed description

This non-interventional, observational, case-control study aims to evaluate the impact of vestibular impairments on the daily life activities and functional development of deaf children aged 0 to 2 years. The study focuses on understanding how vestibular dysfunction, a condition affecting balance, posture, and motor skills, influences children's ability to perform essential daily tasks such as walking, sitting, and interacting with their environment from a occupational therapist point of view.

Study Design:

Participants will be divided into three distinct groups:

  1. Group 1: Deaf children with confirmed vestibular impairment.
  2. Group 2: Deaf children without vestibular impairment.
  3. Group 3 (Control Group): Hearing children without vestibular deficits. A total of 105 children (35 per group) will be enrolled over a three-year period during their consultations at the ENT departement.

Methods and Data Collection:

  • Quantitative Evaluation:

Children's daily life activities will be assessed using the OT Hope 0-5 years questionnaire, which is completed by parents with assistance from an occupational therapist. This tool measures children's competences across key domains, including personal care, play, and social interactions. Responses are categorized into four levels:

  • ""Yes, we can do this.""
  • ""Yes, we can do this with help.""
  • ""We can't do this very well.""
  • ""No, we can't do this."" Scores will be assigned to each response, and the overall scores will be compared between the three groups to identify differences in competences and daily activity performance.
  • Qualitative Evaluation:

It will be proposed to some parents to participate in qualitative interviews designed to explore their experiences, challenges, and strategies related to their child's daily routines and motor development. These interviews will provide insights on the impact of vestibular impairments on family life and the child's autonomy.

Hypotheses:

The study is based on the following hypotheses:

  1. Deaf children with vestibular impairments will have lower scores in daily life activities, especially in motor-related tasks such as walking, compared to the other two groups.
  2. Deaf children without vestibular impairments may show slight differences compared to hearing children due to their hearing loss but will perform better than children with both hearing and vestibular impairments.
  3. The qualitative interviews will reveal specific challenges faced by families of children with vestibular dysfunction and highlight adaptive strategies.

Outcomes:

  • Primary Outcome: Comparison of daily life activity scores between the three groups using the OT Hope 0-5 years tool.
  • Secondary Outcomes: Analysis of qualitative interview data to explore themes related to motor challenges, family adaptation, and participation in daily routines.

Study Duration:

  • Inclusion period: 3 years.
  • Patient participation: Approximately 1 hour (including questionnaire completion and, for some, qualitative interviews).

Ethical and Regulatory Considerations:

The study complies with ethical standards for human research and data confidentiality regulations. Parents' non-opposition will be documented, and all collected data will be anonymized and securely stored.

By exploring both quantitative and qualitative dimensions, this study aims to provide a comprehensive understanding of how vestibular impairments affect the functional development and autonomy of young children, with the ultimate goal of guiding early interventions and improving clinical practices.

Being tested
OT Hope 0 - 5 ans Therapeutic tool, Qualitative interviews with parents
Keywords
Deafness, vestibular disorder, occupational therapy
Medical subject headings
Hearing Loss, Deafness, Vestibular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OT Hope 0 - 5 ans Therapeutic toolOther

    OT Hope 0 - 5 ans Therapeutic tool for self determination of pediatric goals in occupational therapy

  • Qualitative interviews with parentsOther

    qualitative interviews to understand how vestibular impairments affect their child's daily life activities, challenges encountered, and strategies used to support participation.

Study groups in NCT06909266
Study groupRoleWhat they receive
deaf children with vestibular disorderChildren aged 0 to 2 years old
Receives: Other: OT Hope 0 - 5 ans Therapeutic tool; Other: Qualitative interviews with parents
deaf children without vestibular disorderChildren aged 0 to 2 years old
Receives: Other: OT Hope 0 - 5 ans Therapeutic tool; Other: Qualitative interviews with parents
hearing children without vestibular disorderChildren aged 0 to 2 years old
Receives: Other: OT Hope 0 - 5 ans Therapeutic tool; Other: Qualitative interviews with parents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OT Hope 0 - 5 ans Therapeutic tool for self determination of pediatric goals in occupational therapy

    Assessment of daily life activities in children aged 0-2 years using the OT Hope 0-5 tool. Parents rate their child's performance in personal care, play, and social interactions. Scores associated will be compared across three groups to evaluate the impact of vestibular impairments.

    Measured: 15 minutes

Secondary outcomes (1)
  1. Qualitative interviews with parents

    Exploration of parents' perspectives through qualitative interviews to understand how vestibular impairments affect their child's daily life activities, challenges encountered, and strategies used to support participation.

    Measured: 45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2025
  2. Study start27 Mar 2025
  3. Primary completion1 Apr 2028 (estimated)
  4. Study completion1 Apr 2028 (estimated)

Resources

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
Case-control
Time perspective
Prospective
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06909266
Sponsor's protocol ID
APHP250135
Other IDs
IDRCB: 2025-A00243-46
Acronym
IVANS
Status last verified
Nov 2026
First submitted
27 Mar 2025
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Vestibular Dysfunction 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 3 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Audrey MAUDOUX, MD (+33140032449, audrey.maudoux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OT Hope 0 - 5 ans Therapeutic tool for self determination of pediatric goals in occupational therapy (time frame: 15 minutes). 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 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in