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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
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
Study Summary
This trial investigates why some older adults with cochlear implants benefit more from the device than others. It looks at things like age, overall health, and where the implant is placed in the ear. Different types of input (like simple sounds or spoken sentences) are used to examine these questions.
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.Check my eligibility
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.See study design
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 belowSelect...
I became deaf after learning to speak.
Select...
I became deaf after learning to speak.
Timeline
Screening ~ 3 weeks3 visits
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.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amplitude modulation detection performance
Perceptual amplitude discrimination thresholds
Perceptual duration discrimination thresholds
+3 moreSecondary outcome measures
Cortical auditory evoked potential - N1 and P2 amplitude
Cortical auditory evoked potential - N1 and P2 latency
Electrically evoked compound action potential (ECAP)
+3 moreTrial 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
Find a Location
Who is running the clinical trial?
Vanderbilt UniversityOTHER
703 Previous Clinical Trials
6,143,047 Total Patients Enrolled
University of Maryland, College ParkLead Sponsor
155 Previous Clinical Trials
45,365 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
328 Previous Clinical Trials
178,005 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of neurological disorders.I became deaf after learning to speak.You have normal or slightly reduced hearing, or mild to moderate hearing loss.You have a cochlear implant in one or both ears.You are not able to speak using words.I have severe hearing loss.You had surgery to implant something after the year 2004.You have some hearing ability without using a hearing aid at certain frequencies.You have any other known disability or brain-related condition.You have Cochlear-brand implants.You have received a cochlear implant made by the brand Cochlear.You have a cochlear implant in one or both ears.You have had a cochlear implant for at least 1 year.I have had problems with my middle ear.You had surgery to implant something after the year 2004.I became deaf after learning to speak.
Research Study Groups:
This trial has the following groups:- Group 1: Enrolled Participants - Older adults with cochlear implants
- Group 2: Enrolled Participants - Adults with typical hearing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cochlear Hearing Loss Patient Testimony for trial: Trial Name: NCT05554692 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the principal objective of this experiment?
"This clinical trial will gauge the efficacy of cochlear implants over a one year period. The primary outcome measure is perceptual duration discrimination thresholds, while secondary outcomes include electrically evoked compound action potential (ECAP) forward masking recovery, cortical auditory evoked potential - N1 and P2 latency, and ECAP amplitude growth function slope. These measures are used to predict patient performance in terms of sound detection and neural health of associated auditory neurons."
Answered by AI
Is this clinical experiment open to applicants over the age of 45?
"This research trial has stipulated a minimum age of 18, and an upper limit of 85 years old for prospective participants."
Answered by AI
Have recruitment efforts for this research commenced?
"Clinicaltrials.gov affirms that this clinical trial, which was first posted on August 3rd 2022 and last updated September 22nd of the same year, is not accepting new patients at this juncture. However, 407 other medical studies are actively seeking participants right now."
Answered by AI
What qualifications are needed for someone to join this research program?
"Aspiring participants in this clinical trial must have been diagnosed with hearing loss and cochlear, while also falling within the prescribed age range of 18 to 85 years. The total capacity is 300 individuals."
Answered by AI
Who else is applying?
What state do they live in?
Iowa
Ohio
California
How old are they?
65+
What site did they apply to?
University of Maryland, College Park
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have tinnitus in my right ear more than 25 years ago, completely deaf in my right side,.
PatientReceived 1 prior treatment
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