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Mapping Strategies for Cochlear Implant Recipients

N/A

Recruiting

Led By Margaret T Dillon, 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

18-80 years of age at implantation, identify English as native language, Medical Electronics (MED-EL) array recipient, and a postoperative unaided detection threshold of less than or equal to 65 decibel (dB) hearing level (HL) at 125 Hz

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months post-activation

Awards & highlights

Study Summary

This trial will investigate the monaural and binaural hearing of cochlear implant recipients who use different programs. The programs will use different patient and device variables to determine their effect on the recipient's hearing.

Who is the study for?

This trial is for cochlear implant recipients aged 18-80 who consider English their native language, have a MED-EL array, and can detect sounds at or below 65 dB HL at 125 Hz without aid. It's not specified who cannot join the trial.Check my eligibility

What is being tested?

The study is examining how different programming of cochlear implants affects hearing. Participants will try out 'place-based mapping' versus the standard settings to see which offers better speech perception, spatial hearing, and overall satisfaction.See study design

What are the potential side effects?

Since this trial involves non-invasive programming changes in cochlear implants rather than drugs or surgery, traditional side effects are not expected. However, participants may experience differences in hearing quality.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18-80 years old, speak English natively, have a MED-EL implant, and can hear sounds below 65 dB at 125 Hz.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months post-activation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months post-activation

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

Treatment Details

Study Objectives

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

Primary outcome measures

Binaural hearing abilities over time

Monaural perception over time

Secondary outcome measures

Perceived abilities over time

Trial Design

2Treatment groups

Experimental Treatment

Group I: Place-basedExperimental Treatment1 Intervention

Frequency filters adjusted to align with the cochlear place frequency

Group II: DefaultExperimental Treatment1 Intervention

The default frequency filters assigned by the clinical software

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,505 Previous Clinical Trials

4,189,481 Total Patients Enrolled

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH

328 Previous Clinical Trials

178,225 Total Patients Enrolled

Margaret T Dillon, AuDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

1 Previous Clinical Trials

Media Library

default mapping Clinical Trial Eligibility Overview. Trial Name: NCT04722042 — N/A

Cochlear Implants Research Study Groups: Default, Place-based

Cochlear Implants Clinical Trial 2023: default mapping Highlights & Side Effects. Trial Name: NCT04722042 — N/A

default mapping 2023 Treatment Timeline for Medical Study. Trial Name: NCT04722042 — N/A

Frequently Asked Questions

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

Are there still opportunities to partake in this experiment?

"Affirmative. According to clinicaltrials.gov, the research trial which was first uploaded on February 23rd 2021 is actively recruiting individuals for participation. 80 participants are needed and all recruitment will be conducted at a single site."

Answered by AI

To whom is this research opportunity accessible?

"This research is seeking 80 individuals aged 18 - 80 who have cochlear implants, and also meet specific criteria: native English speakers with MED-EL array implants that are showing an unaided detection threshold of 65 decibels or lower at 125 Hz."

Answered by AI

Are participants of sixty years or older being recruited for this experiment?

"As outlined in the inclusion criteria, 18 to 80 year olds are eligible for this medical trial. There is a special cohort of 14 trials specifically recruiting those aged 65 or older and 4 studies geared towards minors under the age of 18."

Answered by AI

What is the current enrollment number of participants in this trial?

"Confirmed. Data hosted on clinicaltrials.gov shows that this medical trial, which was initially listed on February 23rd 2021, is in the process of recruiting applicants. A total of 80 participants are expected from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Place-based Mapping in EAS Listeners

2021. "Place-based Mapping in EAS Listeners". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04722042.