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Search / Trial NCT05962359

Neural Prediction to Enhance Language

Launched by ANN & ROBERT H LURIE CHILDREN'S HOSPITAL OF CHICAGO · Jul 21, 2023

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Hearing Loss Children Parent Mediated Intervention Language Prediction

ClinConnect Summary

This clinical trial is studying how to better predict language development in children with hearing loss who receive cochlear implants. Cochlear implants are devices that can help children hear when they have significant hearing loss. The researchers aim to create models based on brain scans to forecast how well individual children might do with language after getting these implants. This way, they can tailor therapies to better support children who may struggle with language skills, particularly focusing on children who are learning English or Spanish.

To be eligible for the trial, children need to be diagnosed with hearing loss and meet specific criteria for cochlear implantation, such as being 5 years old or younger for one group, or 36 months and younger for another. Families must primarily speak English or Spanish at home. Participants can expect to take part in an educational program that helps parents learn effective strategies to improve their child’s communication skills. This trial is important because it aims to enhance language outcomes for children who might otherwise face challenges due to their hearing loss.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria (Arm 1):
  • 1. Children with sensorineural hearing loss who meet clinical criteria for cochlear implantation in both ears who meet the following age criteria at time cochlear implant evaluation begins:
  • Age 5 years and under.
  • English or Spanish as the dominant language.
  • 2. English or Spanish dominant language in the home.
  • Inclusion Criteria (Arm 2):
  • 1. Children with bilateral sensorineural hearing loss who meet clinical criterial for cochlear implantation
  • 2. English dominant spoken language by family
  • 3. Age at implantation of 36 months and younger when treatment begins
  • 4. Parent or caregiver that is willing to participate who understands spoken English
  • 5. Child is exposed to spoken language by at least one parent (total communication or auditory/oral) in the home
  • Exclusion Criteria (Arm 1):
  • 1. Severe motor and /or cognitive disability that would preclude evaluation of progress
  • 2. Limited electrode insertion likely to significantly impact development of speech perception
  • 3. Hearing loss due to bacterial meningitis
  • 4. Neither English or Spanish as the dominant family language in the home
  • Exclusion Criteria (Arm 2):
  • 1. Severe motor and /or cognitive disability that would preclude evaluation of progress
  • 2. Limited electrode insertion likely to significantly impact development of speech perception
  • 3. Hearing loss due to bacterial meningitis
  • 4. Dominant language other than English
  • 5. Diagnoses or medical conditions expected to impact language development independent of hearing loss
  • 6. Cochlear nerve deficiency in implanted ears or severe cochlear malformation
  • 7. Children already having spoken language who score better than 25th percentile on the Words and Sentences portion of the CDI language evaluation.
  • 8. Child with more than two months CI experience prior to start of treatment

About Ann & Robert H Lurie Children's Hospital Of Chicago

Ann & Robert H. Lurie Children's Hospital of Chicago is a leading pediatric healthcare institution dedicated to advancing child health through innovative research and clinical excellence. As a prominent clinical trial sponsor, the hospital focuses on developing and evaluating novel therapies and treatments tailored for children. With a commitment to evidence-based practices and a multidisciplinary approach, Lurie Children's collaborates with various stakeholders to enhance pediatric care and improve health outcomes for children locally and globally. Through its robust research programs, the hospital aims to transform pediatric medicine and address the unique challenges faced by young patients.

Locations

Chicago, Illinois, United States

Patients applied

0 patients applied

Trial Officials

Nancy M Young, MD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported