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

Not Applicable

Recruiting

• Conditions: Hearing Loss
• Interventions: Device: Mobile Research App (MRA); Other: SOC/validated delivery of the speech perception test material

• Registration Number: NCT06098482
• Lead Sponsor: Cochlear

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-24
• Study Start: 2024-02-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Delivery of speech perception materials in-clinic and at home using the Mobile Research App (MRA)	SOC/validated delivery of the speech perception test material	Cochlear implant and hearing aid recipients will participate in this arm (sub-investigation AI5841B).
Delivery of speech perception materials in-clinic using the Mobile Research App (MRA)	Mobile Research App (MRA)	Cochlear implant recipients will participate in this arm (sub-investigation AI5841A).
Delivery of speech perception materials in-clinic using the Mobile Research App (MRA)	SOC/validated delivery of the speech perception test material	Cochlear implant recipients will participate in this arm (sub-investigation AI5841A).
Delivery of speech perception materials in-clinic and at home using the Mobile Research App (MRA)	Mobile Research App (MRA)	Cochlear implant and hearing aid recipients will participate in this arm (sub-investigation AI5841B).

Primary Outcome Measures

Name	Time	Method
Percent correct performance for the test and retest runs of speech perception ability	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 retest runs of the speech perception ability will be compared.; Scoring: Percentage correct; Range: 0-100%, higher scores equal better performance

Trial Locations

Locations (4)

Denver Research and Technology Labs; 🇺🇸 Lone Tree, Colorado, United States

HEARnet Clinical Studies; 🇦🇺 Melbourne, Victoria, Australia

Hoorzorg van Looveren; 🇧🇪 Wommelgem, Antwerp, Belgium

European Institute for Otorhinolaryngology (EIORL) ENT department Sint-Augustinus Antwerp; 🇧🇪 Antwerp, Belgium