Removing Background Talker Noise for Cochlear Implant Users
Primary Purpose
Hearing Loss
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Noise Reduction
Sponsored by
About this trial
This is an interventional basic science trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
Subjects with CIs 12 years of age and older with no diagnosis of other communicative or cognitive disorders. Subjects must have native or native-like English proficiency.
Exclusion Criteria:
No diagnosed cognitive or communicative disorders (other than hearing loss), presence of acute/chronic otitis media, useable acoustic hearing, and non-English speaking.
Sites / Locations
- New York University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experiment
Arm Description
Subjects will be tested for their ability to understand speech with and without noise reduction
Outcomes
Primary Outcome Measures
Speech Recognition
The % of words correctly understood in various noisy situations will be measured
Secondary Outcome Measures
Full Information
NCT ID
NCT04777669
First Posted
February 25, 2021
Last Updated
July 11, 2022
Sponsor
York Sound Inc
Collaborators
NYU Langone Health
1. Study Identification
Unique Protocol Identification Number
NCT04777669
Brief Title
Removing Background Talker Noise for Cochlear Implant Users
Official Title
Removing Background Talker Noise for Cochlear Implant Users
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
York Sound Inc
Collaborators
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
When hearing-impaired listeners are properly aided with a hearing aid (HA) or cochlear implant (CI), they are often able to comfortably maintain a conversation in quiet environments. However, in group environments, such as a large family dinner, restaurant, or other environment where multiple people are talking simultaneously, hearing-impaired listeners have great difficulty participating in conversations and frequently withdraw or avoid the situation. As such, it would be highly beneficial to implement an algorithm into HAs or CIs to remove background talkers ("babble") from the signal to reduce listening effort for the hearing-impaired listener and allow them to converse as if they were in a quiet environment. Although HAs and CIs frequently incorporate noise reduction algorithms, these algorithms are not effective when the background is babble. The problem of removing babble involves segregating speech from speech. Hence, the spectral properties of the signal and noise are extremely similar.
Despite these challenges, we developed an algorithm to remove background babble. In the following study will test the ability of cochlear implant users to understand speech with background babble noise using our noise reduction algorithm or no noise reduction algorithm. We hypothesize that CI users will be able to understand significantly more speech in babble noise when using our algorithm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experiment
Arm Type
Experimental
Arm Description
Subjects will be tested for their ability to understand speech with and without noise reduction
Intervention Type
Other
Intervention Name(s)
Noise Reduction
Intervention Description
In within subject design, listeners will have background noise removed by a noise reduction algorithm
Primary Outcome Measure Information:
Title
Speech Recognition
Description
The % of words correctly understood in various noisy situations will be measured
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with CIs 12 years of age and older with no diagnosis of other communicative or cognitive disorders. Subjects must have native or native-like English proficiency.
Exclusion Criteria:
No diagnosed cognitive or communicative disorders (other than hearing loss), presence of acute/chronic otitis media, useable acoustic hearing, and non-English speaking.
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Stupak, AuD
Phone
646-501-4153
Email
Natalia.Stupak@nyulangone.org
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data requests will be considered on a case by case basis
Learn more about this trial
Removing Background Talker Noise for Cochlear Implant Users
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