Actively Recruiting

Phase Not Applicable
Age: 7Years - 17Years
All Genders
Healthy Volunteers
ID06040892

Spatial Hearing Rehabilitation in Noise for Bilateral Cochlear Implant Children

Led by Hospices Civils de Lyon · Updated on 2026-02-10

56

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a spatial hearing rehabilitation program called KidTrain designed for children aged 7 to 17 years with bilateral cochlear implants (bCI). The study focuses on improving spatial hearing skills and speech understanding in noisy environments, which are essential for daily interactions but remain limited in bCI children. The program builds on previous pilot studies showing benefits of virtual reality and active listening in adults with bCI, aiming to enhance quality of life through tailored auditory training. The study includes three groups: bCI children receiving two types of rehabilitation programs with varying use of spatialized sensory cues, and a control group of children with normal hearing (NH). The rehabilitation involves multiple sessions manipulating ambient sound complexity and virtual visual cues to simulate real-life auditory environments. The intervention uses virtual reality combined with auditory and visual inputs to engage participants actively during training. Participants will undergo auditory tests including sound localization and speech perception in noise at baseline and at multiple points during and after the intervention. The study also collects questionnaire data on hearing-related quality of life. Researchers will assess auditory performance changes immediately after 4 training sessions and at later visits up to day 98. Compliance with the rehabilitation and the impact of spatialized sensory cues are also monitored to evaluate short- and medium-term benefits.

CONDITIONS

Brief Title

Spatial Hearing Rehabilitation in Noise for Bilateral Cochlear Implant Children

Who Can Participate

Age: 7Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Child aged between 7 and 17 years
  • Normal vision (including correction)
  • Able to understand the experimental instructions
  • Parents or guardians informed of the study and having signed the consent form
  • For normal hearing group: normal tone audiometry with mean threshold ≤ 30 dB
  • For bilateral cochlear implant group: minimum 2 years of binaural experience
  • For bilateral cochlear implant group: average speech recognition ≥ 80% with both implants
Not Eligible

You will not qualify if you...

  • Bilateral vestibular areflexia
  • Attention deficit disorder
  • Known neurological or psychiatric disorders
  • Oculomotor disorders
  • Parents not affiliated to a social security scheme or similar who sign consent
  • Participation in other interventional research with ongoing exclusion period at inclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 week

Participants undergo diagnostic tests including spatial hearing performance tests, speech in noise perception tests, and hearing quality questionnaires to assess baseline auditory abilities.

3 visits (in-person) on Day 0, Day 7, and Day 42

Spatial Hearing Rehabilitation Program

Duration - Approximately 7 weeks

Participants receive a spatial hearing rehabilitation program consisting of up to 8 training sessions manipulating ambient sound and virtual environments to improve auditory spatial skills.

8 sessions over 7 weeks

Long-term Monitoring

Duration - Up to 8 weeks after rehabilitation

Participants are monitored for auditory performance and quality of life effects following the rehabilitation program with evaluation visits to assess short and medium-term outcomes.

3 evaluation visits on Day 42, Day 77, and Day 98

Trial Site Locations

Total: 1 location

1

Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale Hôpital Edouard Herriot, Groupement Hospitalier Centre

Lyon, France, 69437

Actively Recruiting

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Research Team

A

Aurélie Coudert, MD

V

Valérie GAVEAU, MCU

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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Published Research Related To This Trial

Spatial Hearing Difficulties in Reaching Space in Bilateral Cochlear Implant Children Improve With Head Movements.

Aurélie Coudert, Valérie Gaveau, Julie Gatel...

https://pubmed.ncbi.nlm.nih.gov/34225320

Intensive Training of Spatial Hearing Promotes Auditory Abilities of Bilateral Cochlear Implant Adults: A Pilot Study.

Aurélie Coudert, Grégoire Verdelet, Karen T Reilly...

https://pubmed.ncbi.nlm.nih.gov/35943235