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

Hearing Loss Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06098482
• Other study ID #: AI5841
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: Cochlear
• Contact: Ruth English
• Phone: +61 3 8662 3105
• Email: renglish[@]cochlear.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

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 in English, in clinics only. For example, sub-investigation B, will use CVC monosyllabic words in Dutch, in-clinic and in a home environment.

Other:
• SOC/validated delivery of the speech perception test material
Speech material used will be determined by the country/local language and the sub-investigation.

Locations

Country	Name	City	State
Australia	HEARnet Clinical Studies	Melbourne	Victoria
Belgium	European Institute for Otorhinolaryngology (EIORL) ENT department Sint-Augustinus Antwerp	Antwerp
Belgium	Hoorzorg van Looveren	Wommelgem	Antwerp
United States	Denver Research and Technology Labs	Lone Tree	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Countries where clinical trial is conducted

United States,  Australia,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day - immediately post screening.