Validating a mobile app for assessing speech perception in adults with cochlear implants
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
This study is testing a mobile app to see if it can help adults with cochlear implants better understand speech.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cochlear Industry-sponsored |
| Locations | 4 sites (Lone Tree, Colorado and 3 other locations) |
| Trial ID | NCT06098482 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of a Mobile Research App designed to measure and validate speech perception in adult cochlear implant recipients. It will involve a multi-country, multi-center approach where participants will use the app to complete speech perception tests. The study will assess the effectiveness of the app in capturing reliable data on speech perception endpoints. Participants will be adults who use hearing devices and are fluent in the language of the assessment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who use hearing devices, including cochlear implants.
Not a fit: Patients who are not fluent in the language used for the assessment or those unable to comply with the study requirements may not benefit.
Why it matters
Potential benefit: If successful, this study could enhance the assessment of speech perception in cochlear implant recipients, leading to improved patient outcomes.
How similar studies have performed: While similar approaches have been explored, this specific use of a mobile app for speech perception assessment in cochlear implant recipients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lone Tree, Colorado and 3 other locations
- Denver Research and Technology Labs — Lone Tree, Colorado, United States (Completed)
- HEARnet Clinical Studies — Melbourne, Victoria, Australia (Active_not_recruiting)
- European Institute for Otorhinolaryngology (EIORL) ENT department Sint-Augustinus Antwerp — Antwerp, Antwerp, Belgium (Recruiting)
- Hoorzorg van Looveren — Wommelgem, Antwerp, Belgium (Recruiting)
Study contacts
- Study coordinator: Geert De Ceulaer
- Email: gdeceulaer@cochlear.com
- Phone: +32486893006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.