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Cochlear Implantation for Young Single-sided Deaf Children

NCT04738968 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-08-20

No results posted yet for this study

Summary

Children with profound sensorineural unilateral hearing loss (UHL) lag behind in spoken language, cognition, spatial hearing, and academic performance compared to normal hearing (NH) children. Until recently children with UHL were not remediated, thereby assuming that the normal ear would provide sufficient sensory cues for speech understanding. However, this is not true. Because of the difference between the two ears they have difficulty localizing sounds and understanding speech in noise. Such auditory deprivation leads to more global changes in neurocognitive function. It is expected that a cochlear implant in the deaf ear will provide the necessary cues for hearing with two ears. The main objective of this research project is to fundamentally investigate language, cognitive, and spatial/binaural hearing longitudinally in children with unilateral deafness who receive a cochlear implant and age-matched peers.

Conditions

  • Deafness Unilateral

Interventions

DEVICE

Cochlear implant

A cochlear implant is standard care for profoundly deaf persons. It enables hearing through electrical stimulation of the auditory nerve.

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • Cochlear

    collaborator INDUSTRY

  • Agentschap Innoveren & Ondernemen (VLAIO)

    collaborator UNKNOWN

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Astrid van Wieringen, PhD · KU Leuven

  • Irem Adalilar, MSc · KU Leuven

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2024-12-31
Completion
2026-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04738968 on ClinicalTrials.gov