Hearing Loss Clinical Trial
— VALDE-MUOfficial 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
Verified date | March 2024 |
Source | Cochlear |
Contact | Ruth English |
Phone | +61 3 8662 3105 |
renglish[@]cochlear.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Cochlear |
United States, Australia, Belgium,
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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