Auditory Diagnostics and Error-based Treatment (AuDiET)

June 30, 2023 updated by: Radboud University Medical Center

The main objective of this study is to assess the effectiveness of an integrated program of fitting and training interventions aimed at reducing unexpected variability and addressing the specific error patterns of each recipient.

The participants will undergo 1 visit lasting approximately 2 hours at the Radboud university medical center's ENT department, where they will undergo a series of diagnostic tests. Some of the participants will also be asked to self-administer additional tests using a Windows tablet.

Based on the outcomes of speech recognition tests in quiet at the first visit, the participants will be called for follow-up interventions concerning both the fitting of their CI and personalized auditory training based on their personal error patterns. These interventions will take place over the course of approximately 5 months and will be made up of three follow-up visits and a period of self-administered training through a mobile application on a tablet.

One final follow-up visit will check whether any changes from the interventions are retained after four weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500
        • Recruiting
        • Radboud University Medical Center
        • Contact:
        • Principal Investigator:
          • Wendy Huinck, PhD
        • Sub-Investigator:
          • Enrico Migliorini
        • Sub-Investigator:
          • Nikki Tromp
        • Sub-Investigator:
          • Jan-Willem Wasmann

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult (over 18 years old at the time of inclusion )
  • Post-lingually deafened (the subject had a good mastery of spoken language before onset of deafness)
  • Native Dutch speaker
  • Implanted, either unilaterally or bilaterally, with a Cochlear Implant manufactured by Cochlear Ltd (i.e., a Nucleus ® implant).
  • Implanted with one of the following implants: CI422, CI512, CI522, CI532, CI24M, CI24R, CI24RE.
  • Implanted for at least 12 months.

Exclusion Criteria:

  • Known abnormally formed cochlea
  • Known pre-implantation ossification of the cochlea
  • Severe cognitive disorders affecting their ability to understand spoken language
  • Intense facial nerve stimulation
  • Unaddressed electrode tip foldover
  • More than 4 electrodes deactivated because of malfunction (open/short circuit) or lack of response
  • Additional illnesses or handicaps that could impact ability to participate in study, at the clinician's discretion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fitting and Training Intervention

All participants will undergo the full set of diagnostic visits and both Fitting and Training interventions.

The Fitting Intervention is an adjustment of their processors' MAPs based on their error pattern.

The Training Intervention is a personalized training via an app focusing on their most frequent errors.
Diagnostic test: Tone Audiometry
Evaluation of the participants' audiometrical thresholds
Diagnostic test: Spectrotemporal Assessment
Evaluation of the participants' promptness in detecting a modulation of a harmonic complex
Diagnostic test: Phoneme and Speech Perception
Evaluation of the participants' understanding of phonemes and short words, both in quiet and in noise
Diagnostic test: Digit Triplet Test
Evaluation of the participants' ability to discern speech in noise
Other: Personalized fitting
Adjustment of the parameters of the participants' cochlear implants aimed at improving their speech perception
Behavioral: Personalized training
Self-administered training exercises focused on the speech components the participants are experiencing difficulties into

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Percent Speech Recognition
Time Frame: Weeks 1, 10, 14, 18
Given a list of CNC words, this score measures the percentage of correctly identified words.
Weeks 1, 10, 14, 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Distance-based Accuracy Score
Time Frame: Weeks 1, 10, 14, 18
Speech Recognition accuracy score based on phoneme distance, such that mistaking a phoneme for a similar one such as mistaking /k/ for /g/ gives a lower penalty than mistaking a phoneme for a very different one.
Weeks 1, 10, 14, 18
Change in Error Dispersion
Time Frame: Weeks 1, 10, 14, 18
Mathematical quantification of how much the errors made by the subjects are spread between stimuli and responses
Weeks 1, 10, 14, 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Cochlear

Investigators

  • Principal Investigator: Wendy Huinck, PhD, Radboud University Medical Center

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 Major Dates

Study Start (Actual)

May 30, 2022

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

March 23, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-13495

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make IPD available to any researchers not involved in the project

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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