Recruiting NCT06098482
An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mobile Research App (MRA), SOC/validated delivery of the speech perception test material.
- Who it may be relevant to
- Registry conditions: Hearing Loss. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device Mobile Research App (MRA)
The MRA (research tool) is a platform used for the delivery of speech perception material in-clinic outside the sound booth or in the home of the hearing-impaired recipients. 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 app. Speech is streamed via Bluetooth from the iOS device to the sound processor of the CI-recipient. - Other SOC/validated delivery of the speech perception test material
This involves the delivery of speech perception test material in the sound booth in a clinic.
Primary outcome measures
- Percent correct performance for the test and retest runs of speech perception ability [Time frame: 1 day - immediately post screening.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Belgium · 2 centers
- European Institute for Otorhinolaryngology (EIORL) ENT department Sint-Augustinus Antwerp — Antwerp
- Hoorzorg van Looveren — Wommelgem
United States · 1 center
- Denver Research and Technology Labs — Lone Tree
Australia · 1 center
- HEARnet Clinical Studies — Melbourne
Identifiers
NCT: NCT06098482 · AI5841