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NCT05775367 · ClinicalTrials.gov registry record · NA
Cochlear Implants in Young Children With SSD
A NA study of Hearing Loss and Hearing Loss, Unilateral, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05775367: Recruiting NA study of Hearing Loss and Hearing Loss, Unilateral, sponsored by University of North Carolina, Chapel Hill.
NCT05775367 is a NA study of Hearing Loss and Hearing Loss, Unilateral that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 60 participants, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05775367, a NA study of Hearing Loss and Hearing Loss, Unilateral, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness. The main questions it aims to answer are: * Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers? * Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers? Participants will receive a cochlear implant and be followed until they are five years old. During those five years, the investigators will program the device and monitor auditory development. Children will be asked to: * Undergo cochlear implantation * Wear their cochlear implant processor whenever they are awake. * Participate in traditional hearing tests * Participate in traditional hearing testing * Participate in localization testing * Participate in hearing in noise testing * Participate in word recognition testing * Participate in speech, language, and educational evaluations The researchers will compare results to children with typical hearing in both ears and children with single-sided deafness who have not received an implant to observe any differences between the groups.
Primary Outcome
Two ½ lists of the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) will be presented in a single condition: speech in front and masker directed 90 degrees to the normal ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better. All participants will be 5 years old at the time of testing. The study group will use their cochlear implant in conjunction with the normal hearing ear. The SSD control group will use their normal hearing ear
Conditions Studied
Interventions
- DEVICE Cochlear Implant
Study Locations (1)
North Carolina
- The Children's Cochlear Implant Center at UNC - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-07-07 |
| Est. Completion | 2030-05-30 |
| Phase | NA |
What NCT05775367 shows while recruiting
NCT05775367 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower).
The record links to 6 conditions, with Hearing Loss appearing as the primary indexed condition, and to 1 intervention - of which Cochlear Implant is the first listed.
NCT05775367 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05775367 about?
NCT05775367 is a clinical study titled "Cochlear Implants in Young Children With SSD". The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness. The main questions it aims to answer are: * Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers? * A...
What is the current status of trial NCT05775367?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2023-07-07. Estimated completion is 2030-05-30.
What conditions does trial NCT05775367 study?
This clinical trial studies the following conditions: Hearing Loss, Hearing Loss, Unilateral, Single Sided Deafness, Unilateral Deafness, Congenital Hearing Loss.
What interventions are being tested in trial NCT05775367?
The interventions under investigation include: Cochlear Implant (DEVICE).
Who is sponsoring clinical trial NCT05775367?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05775367 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hearing Loss
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05775367's enrollment target sits among peer trials
60 35th of 58 higher than 24 of 58 other Hearing Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hearing Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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