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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06098482
Other study ID # AI5841
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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