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Auditory Diagnostics and Error-based Treatment (AuDiET)

Primary Purpose

Deafness, Bilateral, Deafness Neurosensory, Deafness Permanent

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Tone Audiometry
Spectrotemporal Assessment
Phoneme and Speech Perception
Digit Triplet Test
Personalized fitting
Personalized training
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deafness, Bilateral focused on measuring Cochlear Implant, Speech Perception, Hearing, Speech, Prosthesis Fitting, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, CI522, CI24R/M, CI512, CI612, CI523, CI623.
  • 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.

Sites / Locations

  • Radboud university medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fitting and Training Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Percent Speech Recognition
Given a list of CNC words, this score measures the percentage of correctly identified words.

Secondary Outcome Measures

Change in Distance-based Accuracy Score
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.
Change in Error Dispersion
Mathematical quantification of how much the errors made by the subjects are spread between stimuli and responses

Full Information

First Posted
March 10, 2022
Last Updated
June 30, 2023
Sponsor
Radboud University Medical Center
Collaborators
Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT05307952
Brief Title
Auditory Diagnostics and Error-based Treatment
Acronym
AuDiET
Official Title
Auditory Diagnostics and Error-based Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Cochlear

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness, Bilateral, Deafness Neurosensory, Deafness Permanent
Keywords
Cochlear Implant, Speech Perception, Hearing, Speech, Prosthesis Fitting, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fitting and Training Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Tone Audiometry
Intervention Description
Evaluation of the participants' audiometrical thresholds
Intervention Type
Diagnostic Test
Intervention Name(s)
Spectrotemporal Assessment
Intervention Description
Evaluation of the participants' promptness in detecting a modulation of a harmonic complex
Intervention Type
Diagnostic Test
Intervention Name(s)
Phoneme and Speech Perception
Intervention Description
Evaluation of the participants' understanding of phonemes and short words, both in quiet and in noise
Intervention Type
Diagnostic Test
Intervention Name(s)
Digit Triplet Test
Intervention Description
Evaluation of the participants' ability to discern speech in noise
Intervention Type
Other
Intervention Name(s)
Personalized fitting
Intervention Description
Adjustment of the parameters of the participants' cochlear implants aimed at improving their speech perception
Intervention Type
Behavioral
Intervention Name(s)
Personalized training
Intervention Description
Self-administered training exercises focused on the speech components the participants are experiencing difficulties into
Primary Outcome Measure Information:
Title
Change in Percent Speech Recognition
Description
Given a list of CNC words, this score measures the percentage of correctly identified words.
Time Frame
Weeks 1, 10, 14, 18
Secondary Outcome Measure Information:
Title
Change in Distance-based Accuracy Score
Description
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.
Time Frame
Weeks 1, 10, 14, 18
Title
Change in Error Dispersion
Description
Mathematical quantification of how much the errors made by the subjects are spread between stimuli and responses
Time Frame
Weeks 1, 10, 14, 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Huinck, PhD
Phone
+31243613506
Email
Wendy.Huinck@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Huinck, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud university medical center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Huinck, PhD
Phone
+31243613506
Email
Wendy.Huinck@radboudumc.nl
First Name & Middle Initial & Last Name & Degree
Wendy Huinck, PhD
First Name & Middle Initial & Last Name & Degree
Enrico Migliorini
First Name & Middle Initial & Last Name & Degree
Nikki Tromp
First Name & Middle Initial & Last Name & Degree
Jan-Willem Wasmann

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available to any researchers not involved in the project

Learn more about this trial

Auditory Diagnostics and Error-based Treatment

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