RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-02-05

Study Completion:2025-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06098482

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Ruth English

CONTACT

+61 3 8662 3105

renglish@cochlear.com

Study Locations (Sites)

Denver Research and Technology Labs

Lone Tree, Colorado, 80124

United States

Collaborators and Investigators

Sponsor: Cochlear

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-05

Study Completion Date2025-04-30

Study Record Updates

Study Start Date2024-02-05

Study Completion Date2025-04-30

Terms related to this study

Additional Relevant MeSH Terms

Hearing Loss