Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT05962359
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Months
Maximum Age:
5 Years
Study:
NCT05962359
Study Brief:
Protocol Section:
NCT05962359