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.
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
- Conditions the study is for
- Vestibular Dysfunction, Hearing Loss, Motor Development
- 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.
France1 site, 1 recruiting
- Recruiting
Robert Debré Hospital
Paris, 75019
Audrey MAUDOUX, MD, +33140032449, audrey.maudoux@aphp.fr
Amandine TISSIER, 0140032449, amandine_tissier@hotmail.fr
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:
- Group 1: Deaf children with confirmed vestibular impairment.
- Group 2: Deaf children without vestibular impairment.
- 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:
- 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.
- 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.
- 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.
- Conditions
- Vestibular Dysfunction, Hearing Loss, Motor Development
- 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 group | Role | What they receive |
|---|---|---|
| deaf children with vestibular disorder | Children aged 0 to 2 years old Receives: Other: OT Hope 0 - 5 ans Therapeutic tool; Other: Qualitative interviews with parents | |
| deaf children without vestibular disorder | Children aged 0 to 2 years old Receives: Other: OT Hope 0 - 5 ans Therapeutic tool; Other: Qualitative interviews with parents | |
| hearing children without vestibular disorder | Children 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.
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)
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.
- First posted3 Apr 2025
- Study start27 Mar 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DysfunctionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
- ClinicalTrials.gov ID
- NCT06909266
- Acronym / sponsor ID
- IVANS / APHP250135
- Conditions
- Vestibular Dysfunction, Hearing Loss, Motor Development
- Keywords
- Deafness, vestibular disorder, occupational therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 3 Apr 2025 (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.
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.
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.
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:
- Group 1: Deaf children with confirmed vestibular impairment.
- Group 2: Deaf children without vestibular impairment.
- 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:
- 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.
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| deaf children with vestibular disorder | – | Other: OT Hope 0 - 5 ans Therapeutic tool, Other: Qualitative interviews with parentsChildren aged 0 to 2 years old |
| deaf children without vestibular disorder | – | Other: OT Hope 0 - 5 ans Therapeutic tool, Other: Qualitative interviews with parentsChildren aged 0 to 2 years old |
| hearing children without vestibular disorder | – | Other: OT Hope 0 - 5 ans Therapeutic tool, Other: Qualitative interviews with parentsChildren aged 0 to 2 years old |
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Age groups
- Child
- Study population
- Children coming in consultations in the ENT department
Key inclusion criteria (3 listed)
- Group 1: Deaf children with confirmed vestibular impairment.
- Group 2: Deaf children without vestibular impairment.
- Group 3: Hearing children without vestibular impairment (control group).
Key exclusion criteria (2 listed)
- Presence of neuromotor or orthopedic disorders.
- Presence of pervasive developmental disorders that could interfere with daily activity assessments.
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 |
|---|---|---|
| OT Hope 0 - 5 ans Therapeutic toolOT Hope 0 - 5 ans Therapeutic tool for self determination of pediatric goals in occupational therapy | Other | deaf children with vestibular disorder, deaf children without vestibular disorder, hearing children without vestibular disorder |
| Qualitative interviews with parentsqualitative interviews to understand how vestibular impairments affect their child's daily life activities, challenges encountered, and strategies used to support participation. | Other | deaf children with vestibular disorder, deaf children without vestibular disorder, hearing children without vestibular disorder |
Primary outcome
OT Hope 0 - 5 ans Therapeutic tool for self determination of pediatric goals in occupational therapy
Time frame: 15 minutes
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.
1 secondary outcome
Qualitative interviews with parents
Time frame: 45 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- 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.
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 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.