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Interaural Mismatch in SSD CI Users

Primary Purpose

Outcomes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment-modifications to CI speech processor program
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants for the proposed study will be adults with single-sided deafness. Participants will have at least 6 months experience with their cochlear implant or will be newly implanted with the cochlear implant.

Inclusion criteria for the experienced CI user group and the newly implant group are as follows:

  • 18 years of age and older
  • Postlingual onset of SSD
  • Pure tone average (PTA) at 500, 1000, and 2000 Hz of less than or equal to 30 dB HL in the contralateral ear, known as the normal hearing ear
  • Implanted with or chosen to be implanted with a Nucleus cochlear implant
  • Full insertion of electrode array

Exclusion Criteria:

  • • Not meeting the inclusion criteria

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

CI speech processor programming

Outcomes

Primary Outcome Measures

Speech understanding in noise
Testing in noise will be obtained using the R-Space test which simulates listening in a noisy restaurant. The score is a signal-to-noise ratio that reflects 50% speech understanding in noise.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2022
Last Updated
April 24, 2023
Sponsor
Washington University School of Medicine
Collaborators
Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT05494632
Brief Title
Interaural Mismatch in SSD CI Users
Official Title
Effects of Interaural Loudness and Pitch Mismatch on SSD-CI Performance
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 12, 2022 (Actual)
Primary Completion Date
August 8, 2024 (Anticipated)
Study Completion Date
February 8, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Cochlear

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Interaural loudness and pitch mismatch in single-sided deaf cochlear implant (SSD-CI) recipients reduces binaural processing cues and contributes to performance outcomes, specifically speech understanding in noise and localization. We aim to improve binaural cues through speech processor program modifications that reduce interaural mismatches.
Detailed Description
Effective binaural processing depends on similar loudness growth functions at each ear (Francart et al, 2013, Blamey et al, 2000). The use of interaural level differences (ILDs), perceived as loudness differences, to locate sound is critical given the inability of cochlear implant (CI) recipients to use interaural time differences (ITDs) in binaural processing (Francart et al, 2013, Litovsky et al, 2012). In CI recipients with single-sided deafness (SSD), perceived interaural loudness differences may not be valid indicators of interaural level differences because the CI compresses amplitude (Dorman et al, 2015). Studies suggest better preservation of ILDs may contribute to improved localization and understanding in noise. Since SSD-CI recipients use only one device, an approach to improve their use of ILDs is to match perceived loudness at each ear (Buss et al, 2018). Binaural processing is also affected when signals of equal frequency are not matched in pitch at each ear. In bilateral CI recipients, we found that the greater the pitch mismatch between ears, the poorer the speech understanding in noise. We want to extend this work to SSD-CI recipients. Through CI program modifications, we aim to decrease the pitch and loudness mismatch between the CI ear and the normal hearing ear to improve binaural listening abilities, specifically speech understanding in noise and sound localization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
CI speech processor programming
Intervention Type
Device
Intervention Name(s)
Treatment-modifications to CI speech processor program
Intervention Description
We will modify the CI speech processor program to reduce interaural loudness and pitch mismatches.
Primary Outcome Measure Information:
Title
Speech understanding in noise
Description
Testing in noise will be obtained using the R-Space test which simulates listening in a noisy restaurant. The score is a signal-to-noise ratio that reflects 50% speech understanding in noise.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants for the proposed study will be adults with single-sided deafness. Participants will have at least 6 months experience with their cochlear implant or will be newly implanted with the cochlear implant. Inclusion criteria for the experienced CI user group and the newly implant group are as follows: 18 years of age and older Postlingual onset of SSD Pure tone average (PTA) at 500, 1000, and 2000 Hz of less than or equal to 30 dB HL in the contralateral ear, known as the normal hearing ear Implanted with or chosen to be implanted with a Nucleus cochlear implant Full insertion of electrode array Exclusion Criteria: • Not meeting the inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura K Holden, AuD
Phone
314-362-7246
Email
laurakholden@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jill B Firszt, PhD
Phone
314-362-4760
Email
firsztj@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill B Firszt, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura K Holden, AuD
Phone
314-362-7246
Email
laurakholden@wustl.edu
First Name & Middle Initial & Last Name & Degree
Jill B Firszt, PhD
Phone
314-362-4760
Email
firsztj@wustl.edu
First Name & Middle Initial & Last Name & Degree
Jill B Firszt, PhD

12. IPD Sharing Statement

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Interaural Mismatch in SSD CI Users

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