| NCT ID | NCT05962359 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago |
| Condition | Bilateral Sensorineural Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2023-01-23 |
| Primary Completion | 2027-07-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 700 participants in total. It began in 2023-01-23 with a primary completion date of 2027-07-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The language outcome of children receiving cochlear implantation to address bilateral sensorineural hearing loss is more variable than that of typical hearing children. The research is focused upon development of neural predictive models based upon brain imaging to forecast language after cochlear implantation on the individual child level. The long-term goal is improving children's language by using predictive models to enable a custom "predict to prescribe" approach to intervene with more effective behavioral therapy for children at risk to develop poorer language. The investigators previously developed models for short term language outcome of English-learning implanted children. The aims of this study are to 1. Develop models able to predict long term outcome for English- learning and Spanish-learning children; and 2. To evaluate whether English-learning children predicted to achieve lower language based on the investigators' previously constructed models can demonstrate significant gains from Parent Implemented Communication Treatment (PICT). PICT is an intensive parent education program about strategies to improve children's communication.
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
Contact & Investigator
Nancy M Young, MD
PRINCIPAL INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago
Frequently Asked Questions
Who can join the NCT05962359 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 5 Years, studying Bilateral Sensorineural Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05962359 currently recruiting?
Yes, NCT05962359 is actively recruiting participants. Contact the research team at nyoung@luriechildrens.org for enrollment information.
Where is the NCT05962359 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05962359 clinical trial?
NCT05962359 is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. The principal investigator is Nancy M Young, MD at Ann & Robert H Lurie Children's Hospital of Chicago. The trial plans to enroll 700 participants.