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Cochlear Implant Settings for Childhood Hearing Loss

N/A

Waitlist Available

Led By Lisa Park, AuD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Spoken English as the primary language (speech perception testing conducted in English)

Aged 5 through 17 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-stimulation

Awards & highlights

Study Summary

This trial is investigating whether speech perception is better in pediatric cochlear implant (CI) recipients with functional pre-operative hearing when they use the hearing aid alone or combined electric-acoustic stimulation. Two cohorts of CI recipients aged 6 through 17 years will be evaluated.

Who is the study for?

This trial is for children aged 5-17 with certain types of hearing loss who speak English and have realistic expectations. They must be able to participate in tests, have adequate language skills, and received a specific cochlear implant. Those with oral motor delays, cochlear nerve issues, or cognitive impairments that prevent testing are excluded.Check my eligibility

What is being tested?

The study compares speech perception in kids with pre-operative low frequency hearing using two methods: one group uses a hearing aid alone (HA-alone), the other combines this with electric-acoustic stimulation (EAS). The goal is to see which method better supports speech understanding.See study design

What are the potential side effects?

While not explicitly stated, potential side effects may include discomfort from wearing devices, possible changes in residual hearing levels due to device use or surgery-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I primarily speak and understand English.

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I am between 5 and 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post-stimulation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post-stimulation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-stimulation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean BKB-SIN SNR-50 scores, comparing EAS and CI-alone conditions at 12 months post stimulation (Arm 1 to Arm 2).

Mean CNC word scores, comparing EAS and CI-alone conditions at 12 months post stimulation (Arm 1 to Arm 2).

Secondary outcome measures

Change in percent correct in single word scores in quiet, comparing pre- and post-stimulation scores in both groups

Speech

Mean Pediatric SSQ scores, comparing Pre-operative and 12 month post stimulation scores in both groups.

Other outcome measures

Percent correct in prosodic identification scores, comparing EAS to CI-Alone conditions in Arm 1 participants

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment1 Intervention

Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of > 75 dB HL. Electric Acoustic Speech Processor: Electric only fitting They will be evaluated in the traditional fully electric condition only.

Group II: Arm 1Experimental Treatment1 Intervention

Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: EAS fitting. They will be evaluated in the EAS condition and the hearing aid (HA) alone condition.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,504 Previous Clinical Trials

4,187,622 Total Patients Enrolled

Med-El CorporationIndustry Sponsor

23 Previous Clinical Trials

973 Total Patients Enrolled

Lisa Park, AuDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

1 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

Electric Acoustic Speech Processor: EAS fitting Clinical Trial Eligibility Overview. Trial Name: NCT03379870 — N/A

Childhood Hearing Loss Research Study Groups: Arm 1, Arm 2

Childhood Hearing Loss Clinical Trial 2023: Electric Acoustic Speech Processor: EAS fitting Highlights & Side Effects. Trial Name: NCT03379870 — N/A

Electric Acoustic Speech Processor: EAS fitting 2023 Treatment Timeline for Medical Study. Trial Name: NCT03379870 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity to sign up for this medical experiment?

"The eligibility requirements for this trial involves having dysacusis and being between the ages of 5 years to 18 years old. This research project is looking to enroll approximately 40 subjects."

Answered by AI

Are there any open slots in this trial available for volunteers?

"Contrary to popular belief, this clinical trial has stopped recruitment as of November 1st 2022. It was initially posted on May 25th 2018 and is no longer seeking participants; however, there are 170 other studies currently accepting patients."

Answered by AI