- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07323862
Assessment of a Method to Improve Cochlear Implant Users' Speech Perception in Noisy Environments While Maintaining Their Ability to Determine Where a Sound Originates From
Spatially Transparent Binaural Beamforming for Noise Reduction for Cochlear Implant Processors
The goal of this clinical trial is to determine if a new algorithm can improve speech perception for cochlear implant users. The main questions it aims to answer [is/are]:
- Does the algorithm improve speech perception in noisy environments?
- Does the algorithm allow listeners to determine where a sound is coming from?
Participants will
- Listen to and repeat sentences presented in the presence of noise
- Indicate the location that sounds originated from
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Justin Aronoff, PhD
- Phone Number: 217 244-2154
- Email: jaronoff@illinois.edu
Study Locations
-
-
Illinois
-
Champaign, Illinois, United States, 61820
- Speech and Hearing Science Building
-
Contact:
- Justin Aronoff, PhD
- Phone Number: 217 244-2154
- Email: jaronoff@illinois.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must have bilateral cochlear implants from Cochlear or Advanced Bionics
Exclusion Criteria:
- Non-native English speakers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Speech perception and localization with different beamformers
Participants will listen to stimuli processed by different beamformer algorithms and repeat speech presented in noise and identify the location that sound originated from.
|
Sound will be preprocessed with different beamformer algorithms and presented either through the auxiliary input port or via a streaming device to the participants' cochlear implant processor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent correct scores on speech perception in noise.
Time Frame: Enrollment to 9 months
|
The speech perception in noise test consists of lists of sentences in the presence of multi-talker babble or diffuse noise.
The target location will vary across conditions.
Participants will need to repeat back as much of the target sentence as they can.
|
Enrollment to 9 months
|
|
Root mean square error for sound source localization
Time Frame: Enrollment to 9 months
|
The localization test will involve a target speaker in the presence of multi-speaker babble or diffuse noise.
The virtual location of the sound sources will be manipulated and participants will need to indicate the location of the target speaker.
|
Enrollment to 9 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB25-0736
- 1R43DC023172-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
The data that will be shared will be made available no later than the time of an associated publication or one year after the end of the performance period.
Per the policies of the Illinois Data Bank, data will be available for at least five years after it is first shared.
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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