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An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App (VALDE-MU)

Primary Purpose

Hearing Loss

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
the Mobile Research App
SOC/validated delivery of the speech perception test material
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hearing Loss

Eligibility Criteria

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

Inclusion Criteria: Adults 18 years of age or older. Uses a hearing device or devices (hearing aid/s and/or cochlear implant/s). Fluent speaker in the language used to assess clinical performance as judged by the investigator. Willing and able to provide written informed consent. Exclusion Criteria: Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation). Women who are pregnant.

Sites / Locations

  • Denver Research and Technology Labs
  • HEARnet Clinical Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Delivery of speech perception materials using the experimental method (Mobile Research App)

Standard of Care validated delivery of speech perception materials

Arm Description

Outcomes

Primary Outcome Measures

To determine if test-retest reliability
To determine if test-retest reliability with a correlation greater than or equal to 0.8 can be achieved for speech perception ability measured on the MRA outside the sound booth, percent correct performance for the test and rest runs of the speech perception ability will be compared. Scoring: Percentage correct Range: 0-100%, higher scores equal better performance

Secondary Outcome Measures

Full Information

First Posted
October 19, 2023
Last Updated
October 19, 2023
Sponsor
Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT06098482
Brief Title
An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
Acronym
VALDE-MU
Official Title
A Prospective, Repeated-measures Investigation to Validate Digital Speech Perception Endpoints in Adult Cochlear Implant Recipients Using the Mobile Research App: a Master Umbrella Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 30, 2023 (Anticipated)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear

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
The study is a feasibility, prospective, repeated-measures, multi-country, multi-centre, study of the Mobile Research App to measure and validate speech perception endpoints in adult cochlear implant recipients.

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
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Delivery of speech perception materials using the experimental method (Mobile Research App)
Arm Type
Experimental
Arm Title
Standard of Care validated delivery of speech perception materials
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
the Mobile Research App
Intervention Description
The MRA speech testing module delivers speech material via streaming to the single implanted ears of cochlear implant recipients. The recipient listens to the speech material and responds with what was heard via the keypad on the app. Speech is streamed via Bluetooth from the iOS device to the sound processor of the CI-recipient. Speech material used will be determined by the country/local language and the sub-investigation. For example, sub-investigation A, will use CNC monosyllabic words.
Intervention Type
Device
Intervention Name(s)
SOC/validated delivery of the speech perception test material
Intervention Description
Speech material used will be determined by the country/local language and the sub-investigation. For example, sub-investigation A, will use CNC monosyllabic words.
Primary Outcome Measure Information:
Title
To determine if test-retest reliability
Description
To determine if test-retest reliability with a correlation greater than or equal to 0.8 can be achieved for speech perception ability measured on the MRA outside the sound booth, percent correct performance for the test and rest runs of the speech perception ability will be compared. Scoring: Percentage correct Range: 0-100%, higher scores equal better performance
Time Frame
1 day - immediately post screening.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults 18 years of age or older. Uses a hearing device or devices (hearing aid/s and/or cochlear implant/s). Fluent speaker in the language used to assess clinical performance as judged by the investigator. Willing and able to provide written informed consent. Exclusion Criteria: Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation). Women who are pregnant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth English
Phone
+61 3 8662 3105
Email
renglish@cochlear.com
Facility Information:
Facility Name
Denver Research and Technology Labs
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bryan McDonald
Phone
303-472-4061
Email
bmcdonald@cochlear.com
Facility Name
HEARnet Clinical Studies
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth English
Phone
+61 3 8662 3105
Email
renglish@cochlear.com

12. IPD Sharing Statement

Plan to Share IPD
No

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An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App

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