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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 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 28 participants.

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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.

Interventions

  • DEVICE Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting
  • DEVICE Electric Acoustic Speech Processor: Full-electric stimulation fitting

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2018-05-25
Est. Completion 2023-12-14
Phase NA

What the Registry Record Tells You About NCT03379870

The ClinicalTrials.gov registry entry for NCT03379870 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

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 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.