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Diagnostic Auditory Tests for Hearing Loss in Cochlear Implantees

N/A
Waitlist Available
Led By Matthew J. Goupell, PhD
Research Sponsored by University of Maryland, College Park
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Post-lingual onset of deafness
post-lingual onset of deafness
Must not have
History of neurological disorders
Severe hearing loss
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time frame: post-treatment - after at least 1 year use of a cochlear implant if ci user. not collected from nh listeners. this measure will be collected once within a 6-month time period for each participant.
Awards & highlights

Summary

This trial studies older adults using cochlear implants to understand why some benefit more than others. It looks at how aging and the health of hearing pathways affect their ability to process sounds. The goal is to improve guidance and outcomes for older adults using these devices.

Who is the study for?
This trial is for older adults with post-lingual deafness who have been using a Cochlear-brand cochlear implant for over a year. Candidates should have normal to moderate hearing loss and must not be pregnant, use non-Cochlear implants, or have severe hearing loss or neurological disorders.
What is being tested?
The study tests how aging, health of auditory pathways, and the placement of cochlear implant electrodes affect speech perception in older users. It involves diagnostic tests on cochlear implant function and auditory processing using various sounds.
What are the potential side effects?
Since this trial focuses on diagnostic testing rather than medication or invasive procedures, side effects are minimal but may include discomfort from wearing testing equipment or fatigue from participating in the study sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I became deaf after learning to speak.
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I became deaf after learning to speak.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of neurological disorders.
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I have severe hearing loss.
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I have had problems with my middle ear.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: post-treatment - after at least 1 year use of a cochlear implant if ci user. not collected from nh listeners. this measure will be collected once within a 6-month time period for each participant.
This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: post-treatment - after at least 1 year use of a cochlear implant if ci user. not collected from nh listeners. this measure will be collected once within a 6-month time period for each participant. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Amplitude modulation detection performance
Perceptual amplitude discrimination thresholds
Perceptual duration discrimination thresholds
+3 more
Secondary study objectives
Cortical auditory evoked potential - N1 and P2 amplitude
Cortical auditory evoked potential - N1 and P2 latency
Electrically evoked compound action potential (ECAP)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Enrolled Participants - Older adults with cochlear implantsExperimental Treatment1 Intervention
Individuals who already use at least one cochlear implant.
Group II: Enrolled Participants - Adults with typical hearingExperimental Treatment1 Intervention
Control group to provide baseline or comparison data

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cochlear implants treat cochlear hearing loss by electrically stimulating the auditory nerve, bypassing damaged hair cells in the cochlea. This direct activation of the auditory nerve allows the brain to perceive sound, making it a vital option for patients whose hearing loss is too severe for traditional hearing aids to be effective. This mechanism is essential as it provides a means to restore hearing function, significantly improving the quality of life for individuals with profound hearing loss.
[Biological therapies in otology. German version].

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityOTHER
710 Previous Clinical Trials
6,143,568 Total Patients Enrolled
University of Maryland, College ParkLead Sponsor
158 Previous Clinical Trials
46,116 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
348 Previous Clinical Trials
180,445 Total Patients Enrolled

Media Library

Enrolled Participants - Older adults with cochlear implants Clinical Trial Eligibility Overview. Trial Name: NCT05554692 — N/A
Cochlear Hearing Loss Research Study Groups: Enrolled Participants - Older adults with cochlear implants, Enrolled Participants - Adults with typical hearing
Cochlear Hearing Loss Clinical Trial 2023: Enrolled Participants - Older adults with cochlear implants Highlights & Side Effects. Trial Name: NCT05554692 — N/A
Enrolled Participants - Older adults with cochlear implants 2023 Treatment Timeline for Medical Study. Trial Name: NCT05554692 — N/A
Cochlear Hearing Loss Patient Testimony for trial: Trial Name: NCT05554692 — N/A
~156 spots leftby Mar 2027