Using brain imaging to improve language outcomes for children with hearing loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research focuses on developing neural predictive models based on brain imaging to forecast language outcomes for children receiving cochlear implants due to bilateral sensorineural hearing loss. The study aims to create a custom 'predict to prescribe' approach that enhances behavioral therapy for children at risk of poor language development. Up to 700 children will be recruited from five cochlear implant programs across the United States and followed for up to four years post-implantation. Data will be collected from medical records, audiological evaluations, and parental surveys to assess language and communication abilities.

Why it matters

Who can join: the full rules

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

Where it's running

• Ann & Robert H. Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Nancy M Young, MD — Ann & Robert H Lurie Children's Hospital of Chicago
• Study coordinator: Nancy M Young, MD
• Email: nyoung@luriechildrens.org
• Phone: 312-227-6812

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Binaural cue sensitivity with combined electric and acoustic hearing in children and adults

  This project will test whether children and adults with cochlear implants and preserved low-frequency hearing can use binaural hearing cues better when they have both electric and acoustic stimulation.

  Recruiting Hearts for Hearing · Oklahoma City, Oklahoma · NCT07356128

• Comparing computer-based auditory training with standard care for cochlear implant patients

  This study tests if a free computer-based training program can help adults with cochlear implants understand speech better and improve their quality of life compared to standard training methods.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT06607146

• Understanding social cognition deficits in autism and psychosis

  This study is testing how a social skills program can help improve social understanding in teenagers with autism and those with schizophrenia, while also looking at how their brains work differently.

  Recruiting Loma Linda University · Loma Linda, California · NCT05185128

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.