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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT03886168
Eligibility Criteria:
Inclusion Criteria:
1. Children aged 4 to 12 years of age
2. Prelingual onset of deafness
3. At least one CI and bilateral moderate to profound sensorineural hearing loss
* for children with a single CI, audiometric thresholds in the non-CI ear must be consistent with at least a moderate to profound sensorineural hearing loss
4. Cochlear implantation prior to 4 years of age
5. Nonverbal cognitive abilities within the typical range
6. No confounding diagnosis such as autism spectrum disorder, neurological disorder, or general cognitive impairment
7. Pre-operative CT scan of head performed as standard of care CI work-up
8. Post-operative CT scan--obtained either before enrollment (per VUMC CI program standard of care) or after informed consent
Exclusion Criteria:
1. Severe anatomical abnormality(s) of the temporal bone.
2. Onset of moderate-to-profound sensorineural hearing loss after 2 years of age
3. Nonverbal intelligence standard score \< 85
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
12 Years
Study:
NCT03886168
Study Brief:
Protocol Section:
NCT03886168