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

Sponsor

Cochlear (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06098482

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss	Device: the Mobile Research App Device: SOC/validated delivery of the speech perception test material	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Anticipated Study Start Date :

Nov 30, 2023

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Delivery of speech perception materials using the experimental method (Mobile Research App)	Device: the Mobile Research App 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.
Active Comparator: Standard of Care validated delivery of speech perception materials	Device: SOC/validated delivery of the speech perception test material 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.

Arm

Intervention/Treatment

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

Device: the Mobile Research App

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.

Active Comparator: Standard of Care validated delivery of speech perception materials

Device: SOC/validated delivery of the speech perception test material

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.

Outcome Measures

Primary Outcome Measures

To determine if test-retest reliability [1 day - immediately post screening.]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Denver Research and Technology Labs	Lone Tree	Colorado	United States	80124
2	HEARnet Clinical Studies	Melbourne	Victoria	Australia	3053

Sponsors and Collaborators

Cochlear

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cochlear

ClinicalTrials.gov Identifier:

NCT06098482

Other Study ID Numbers:

AI5841

First Posted:

Oct 24, 2023

Last Update Posted:

Oct 24, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hearing Loss

Study Results

No Results Posted as of Oct 24, 2023