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

NCT06909266 | Not Yet Recruiting

• 2 other identifiers: APHP250135IDRCB: 2025-A00243-46
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Vestibular Dysfunction; Hearing Loss; Motor Development

Keywords

Deafness; vestibular disorder; occupational therapy

Outcome Measures

Primary Outcomes (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.

  15 minutes

Secondary Outcomes (1)

• Qualitative interviews with parents

  45 minutes

Study Arms (3)

deaf children with vestibular disorder

Children aged 0 to 2 years old

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

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

Other: OT Hope 0 - 5 ans Therapeutic tool; Other: Qualitative interviews with parents

Interventions

OT Hope 0 - 5 ans Therapeutic tool OTHER

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

deaf children with vestibular disorder; deaf children without vestibular disorder; hearing children without vestibular disorder

Qualitative interviews with parents OTHER

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

deaf children with vestibular disorder; deaf children without vestibular disorder; hearing children without vestibular disorder

Eligibility Criteria

• Age: 1 Day - 2 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children coming in consultations in the ENT department

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debré Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

Hearing Loss; Deafness; Vestibular Diseases

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Labyrinth Diseases

Study Officials

• Audrey MAUDOUX, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Audrey MAUDOUX, MD

CONTACT

+33140032449; audrey.maudoux@aphp.fr

Amandine TISSIER, MD

CONTACT

+33140032449; amandine_tissier@hotmail.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: March 27, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

FR (1)