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Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear

Primary Purpose

Hearing Loss, Sensorineural

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CROS
Hearing Aid
Cochlear Implant Alone
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Sensorineural focused on measuring Cochlear Implant, Hearing Loss, Hearing Aids, Hearing Tests

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria*:

  • An Advanced Bionics cochlear implant recipient with at least 6 months of listening experience
  • Low frequency Pure Tone Audiometry (PTA)

Exclusion Criteria*:

  • Non-English speakers

    • Additional Inclusion and Exclusion criteria apply

Sites / Locations

  • University of Colorado School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Cochlear Implant and Hearing Aid

Cochlear Implant alone

Cochlear Implant and CROS

Arm Description

Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests.

Subject only uses the cochlear implant; hearing on the contralateral side is unaided.

Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device.

Outcomes

Primary Outcome Measures

Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #1 will assess how well the listener can hear with his/her cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: Omni: from all directions Ipsi: the same side Front Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #2 will assess how well the listener can hear wearing his/her cochlear implant and a CROS (Contralateral Routing of Signals device). A CROS is a device on the opposite ear that sends the nose to the cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: Omni: from all directions Ipsi: the same side Front Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #3 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: Omni: from all directions Ipsi: the same side Front Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

Secondary Outcome Measures

Full Information

First Posted
February 19, 2019
Last Updated
April 14, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03867396
Brief Title
Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear
Official Title
Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients Using Either a Conventional Hearing Aid or a CROS Device on the Contralateral Ear
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
February 11, 2021 (Actual)
Study Completion Date
February 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

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
Speech understanding in noise remains the greatest challenge for people using cochlear implants, particularly when the speech of interest comes from the side of the head opposite to the implant. Recent findings in hearing technology allow for people to either use a hearing aid or a Contralateral Routing of Signal (CROS) device on the non-implanted ear. Differences in speech understanding may result depending on the device chosen by a person, and these differences may be measureable through speech discrimination measurement methods. This study intends to determine whether or not a CROS device improves speech perception in noise when the source of the speech of interest originates from the side of the head opposite to the implant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
Keywords
Cochlear Implant, Hearing Loss, Hearing Aids, Hearing Tests

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will be randomized into a group where they wear one of the processors and the order of conditions will be assessed, then they will switch to wear the other processor and the order of conditions will be assessed.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cochlear Implant and Hearing Aid
Arm Type
Active Comparator
Arm Description
Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests.
Arm Title
Cochlear Implant alone
Arm Type
Active Comparator
Arm Description
Subject only uses the cochlear implant; hearing on the contralateral side is unaided.
Arm Title
Cochlear Implant and CROS
Arm Type
Experimental
Arm Description
Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device.
Intervention Type
Device
Intervention Name(s)
CROS
Intervention Description
Advanced Bionics CROS
Intervention Type
Device
Intervention Name(s)
Hearing Aid
Intervention Description
Advanced Bionics Naida hearing aid
Intervention Type
Other
Intervention Name(s)
Cochlear Implant Alone
Intervention Description
No hearing device on contralateral ear
Primary Outcome Measure Information:
Title
Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
Description
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #1 will assess how well the listener can hear with his/her cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: Omni: from all directions Ipsi: the same side Front Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
Time Frame
12 minutes
Title
CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
Description
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #2 will assess how well the listener can hear wearing his/her cochlear implant and a CROS (Contralateral Routing of Signals device). A CROS is a device on the opposite ear that sends the nose to the cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: Omni: from all directions Ipsi: the same side Front Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
Time Frame
12 minutes
Title
CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
Description
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #3 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: Omni: from all directions Ipsi: the same side Front Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
Time Frame
12 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria*: An Advanced Bionics cochlear implant recipient with at least 6 months of listening experience Low frequency Pure Tone Audiometry (PTA) Exclusion Criteria*: Non-English speakers Additional Inclusion and Exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melinda Anderson, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be shared with Advanced Bionics.
IPD Sharing Time Frame
From first patient through Institutional Review Board (IRB) study close.
IPD Sharing Access Criteria
The de-identified data will be shared to with Advanced Bionics in a password protected Excel sheet downloaded from research database.

Learn more about this trial

Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear

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