Cochlear Implantation for Young Single-sided Deaf Children

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• Spoken language comprehension — Every 6 months between 2nd and 5th birthday
  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.
• Spoken language production (young children) — Every 6 months between 2nd and 5th birthday
  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.
• Spoken language production (older children) — Yearly from the age of 5, until study completion (average period: 2 years)
  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.
• Spatial speech perception in noise — Yearly from the age of 4, until study completion (average period: 3 years)
  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.
• Sound localization — Yearly from the age of 4, until study completion (average period: 3 years)
  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.

Trial sites (4)

More Universitaire Ziekenhuizen KU Leuven trials in Belgium