Cochlear Implantation for Young Single-sided Deaf Children

NCT04738968 | Active Not Recruiting DMC

• 1 other identifier: S57318
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

auditory rehabilitation; cochlear implant; single-sided deafness

Outcome Measures

Primary Outcomes (5)

• Spoken language comprehension

  The Schlichting Test for Receptive Language is a language comprehension test for children aged 2 to 7 years. Results are reported as an age-referenced language comprehension quotient based on the total score.

  Every 6 months between 2nd and 5th birthday

• Spoken language production (young children)

  The Schlichting Test for Expressive Language is a language production test for children aged 2 to 7 years. Results are reported as age-referenced language quotients for each subtest, namely (1) expressive vocabulary, (2) morphosyntactic skills, (3) auditory memory, (4) pseudoword repetition, (5) story telling.

  Every 6 months between 2nd and 5th birthday

• Spoken language production (older children)

  The Clinical Evaluation of Language Fundamentals (CELF-4-NL) is a language test for children aged 5 to 18 years. Results are reported as age-referenced scores for some of the subtests, namely (1) word structure, (2) sentence repetition, (3) sentence production, (4) word categories, (5) phonologic awareness.

  Yearly from the age of 5, until study completion (average period: 2 years)

• Spatial speech perception in noise

  Speech perception in noise is measured for three spatial conditions using the LittleLINT speech material (numbers 1-10). Results are reported for each condition as the speech reception threshold, i.e. the level (in decibel signal-to-noise ratio, dB SNR) at which 50% of the speech is understood. Children with a CI are tested both with and without their device.

  Yearly from the age of 4, until study completion (average period: 3 years)

• Sound localization

  Sound localization is assessed in a 9-loudspeaker setup with 15° degrees spacing between the loudspeakers. The stimulus is a 1-second broadband telephone sound. Results are reported as the mean absolute error, i.e. the average difference (in degrees) between the active loudspeaker and the child's response. Children with a CI are tested both with and without their device.

  Yearly from the age of 4, until study completion (average period: 3 years)

Secondary Outcomes (4)

• Cognitive development (young children)

  Every 6 months until the age of 3.5 years

• Cognitive development (older children)

  At 4 and 6 years of age (i.e. twice in total)

• Functional balance

  Yearly from the age of 4, until study completion (average period: 3 years)

• Speech perception with the cochlear implant alone

  At clinical visits after the age of 3, on average 2 times per year, until study completion (average period: 4 years)

Other Outcomes (1)

• Binaural integration and cortical symmetry

  One EEG session after the age of 5

Study Arms (3)

Cochlear implant for single-sided deafness

EXPERIMENTAL

Children with single-sided deafness, cochlear implant in the deaf ear

Device: Cochlear implant

Control single-sided deafness

NO INTERVENTION

Children with single-sided deafness, no intervention

Control normal hearing

NO INTERVENTION

Children with normal hearing, no intervention

Interventions

Cochlear implant DEVICE

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

Cochlear implant for single-sided deafness

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• profoundly hearing impaired in one ear
• normal hearing in contralateral ear

You may not qualify if:

• none

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator
• Cochlear: collaborator
• Agentschap Innoveren & Ondernemen (VLAIO): collaborator

Study Sites (4)

Antwerp University Hospital

Antwerp, Belgium

Location

GZA Hospitals

Antwerp, Belgium

Location

Ghent University Hospital

Ghent, Belgium

Location

University Hospitals Leuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Hearing Loss, Unilateral

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Officials

• Astrid van Wieringen, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Irem Adalilar, MSc

  KU Leuven

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: It is known whether the child has a cochlear implant or not
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to either the test or the control group

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: February 4, 2021
• Study Start: January 1, 2015
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

BE (4)