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NCT03379870 · ClinicalTrials.gov registry record · NA
Outcomes in Children With Pre-operative Residual Hearing
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT03379870: Completed NA study, sponsored by University of North Carolina, Chapel Hill.
NCT03379870 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03379870, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study Summary
Purpose: Routine clinical care and pilot study data has shown evidence of postoperative hearing preservation in pediatric cochlear implant (CI) recipients. The primary aim of this study is to investigate speech perception performance in pediatric CI recipients with functional pre-operative hearing. Participants: Two cohorts of CI recipients aged 6 through 17 years who had pre-operative low frequency residual hearing. Subjects in Arm 1 (EAS Arm; electric-acoustic stimulation) will present with a post-operative low frequency pure tone average (125, 250, and 500 Hz) of ≤ 75 dB HL, and those in Arm 2 (FES Arm; full-electric stimulation) will present with a post-operative low frequency pure tone average (LFPTA) that exceeds 75 dB HL. Procedures (methods): Subjects will complete speech perception and quality of life testing during post-operative intervals. Subjects in the EAS Arm will be evaluated with combined electric-acoustic stimulation (EAS). Subjects in FES Arm will be evaluated with FES alone.
Primary Outcome
The Consonant Nucleus Consonant (CNC) word list is established as a standard test of speech perception outcomes. Results for EAS and FES Arms at 12 months post stimulation will be compared. Lower scores indicate a poorer outcome and higher scores a better outcome. Scale 0 - 100%
Interventions
- DEVICE Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting
- DEVICE Electric Acoustic Speech Processor: Full-electric stimulation fitting
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2018-05-25 |
| Est. Completion | 2023-12-14 |
| Phase | NA |
What the finished NCT03379870 record still lists
NCT03379870 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting is the first listed.
NCT03379870 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03379870 about?
NCT03379870 is a clinical study titled "Outcomes in Children With Pre-operative Residual Hearing". Purpose: Routine clinical care and pilot study data has shown evidence of postoperative hearing preservation in pediatric cochlear implant (CI) recipients. The primary aim of this study is to investigate speech perception performance in pediatric CI recipients with functional pre-operative hearing. ...
What is the current status of trial NCT03379870?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2018-05-25. Estimated completion is 2023-12-14.
What interventions are being tested in trial NCT03379870?
The interventions under investigation include: Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting (DEVICE), Electric Acoustic Speech Processor: Full-electric stimulation fitting (DEVICE).
Who is sponsoring clinical trial NCT03379870?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03379870's enrollment target sits among peer trials
28 1704th of 2000 higher than 293 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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