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New treatment option for Bilateral Sensorineural Hearing Loss
Official title Neural Prediction to Enhance Language
ClinicalTrials.gov ID: NCT05962359
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 5
You may be able to join if
- (Arm 1):
- Children with sensorineural hearing loss who meet clinical criteria for cochlear implantation in both ears who meet the following age criteria at...
- Age 5 years and under.
- English or Spanish as the dominant language.
- English or Spanish dominant language in the home. (Arm 2):
You likely can't join if
- (Arm 1):
- Severe motor and /or cognitive disability that would preclude evaluation of progress
- Limited electrode insertion likely to significantly impact development of speech perception
- Hearing loss due to bacterial meningitis
- Neither English or Spanish as the dominant family language in the home Exclusion Criteria (Arm 2):
- Severe motor and /or cognitive disability that would preclude evaluation of progress
See the full eligibility criteria
- (Arm 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.
- English or Spanish dominant language in the home. (Arm 2):
- Children with bilateral sensorineural hearing loss who meet clinical criterial for cochlear implantation
- English dominant spoken language by family
- Age at implantation of 36 months and younger when treatment begins
- Parent or caregiver that is willing to participate who understands spoken English
- Child is exposed to spoken language by at least one parent (total communication or auditory/oral) in the home
- (Arm 1):
- Severe motor and /or cognitive disability that would preclude evaluation of progress
- Limited electrode insertion likely to significantly impact development of speech perception
- Hearing loss due to bacterial meningitis
- Neither English or Spanish as the dominant family language in the home Exclusion Criteria (Arm 2):
- Severe motor and /or cognitive disability that would preclude evaluation of progress
- Limited electrode insertion likely to significantly impact development of speech perception
- Hearing loss due to bacterial meningitis
- Dominant language other than English
- Diagnoses or medical conditions expected to impact language development independent of hearing loss
- Cochlear nerve deficiency in implanted ears or severe cochlear malformation
- Children already having spoken language who score better than 25th percentile on the Words and Sentences portion of the CDI language evaluation.
- Child with more than two months CI experience prior to start of treatment
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 months to 5 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.