Deafness, BilateralAuDiETNCT05307952
Auditory Diagnostics and Error-based Treatment
A study testing Tone Audiometry, Spectrotemporal Assessment and Phoneme and Speech Perception in people with Deafness, Bilateral and Deafness Neurosensory, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deafness, Bilateral, Deafness Neurosensory, Deafness Permanent
- What is being tested?
- Tone Audiometry, Spectrotemporal Assessment and Phoneme and Speech Perception
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 May 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud university medical center
Nijmegen, Gelderland, 6500
Wendy Huinck, PhD, +31243613506, Wendy.Huinck@radboudumc.nl
Wendy Huinck, PhD
About this study
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.
Read more
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.
- Being tested
- Tone Audiometry, Spectrotemporal Assessment, Phoneme and Speech Perception, Digit Triplet Test, Personalized fitting
- Keywords
- Cochlear Implant, Speech Perception, Hearing, Speech, Prosthesis Fitting, Rehabilitation
- Medical subject headings
- Hearing Loss, Bilateral, Hearing Loss, Sensorineural, Deafness, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tone AudiometryDiagnostic test
Evaluation of the participants' audiometrical thresholds
Spectrotemporal AssessmentDiagnostic test
Evaluation of the participants' promptness in detecting a modulation of a harmonic complex
Phoneme and Speech PerceptionDiagnostic test
Evaluation of the participants' understanding of phonemes and short words, both in quiet and in noise
Digit Triplet TestDiagnostic test
Evaluation of the participants' ability to discern speech in noise
Personalized fittingOther
Adjustment of the parameters of the participants' cochlear implants aimed at improving their speech perception
Personalized trainingBehavioural
Self-administered training exercises focused on the speech components the participants are experiencing difficulties into
| Study group | Role | What they receive |
|---|---|---|
| Fitting and Training Intervention | Experimental | 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. Receives: Diagnostic Test: Tone Audiometry; Diagnostic Test: Spectrotemporal Assessment; Diagnostic Test: Phoneme and Speech Perception; Diagnostic Test: Digit Triplet Test; Other: Personalized fitting; Behavioral: Personalized training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent Speech Recognition
Given a list of CNC words, this score measures the percentage of correctly identified words.
Measured: Weeks 1, 10, 14, 18
Secondary outcomes (2)
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.
Measured: Weeks 1, 10, 14, 18
Change in Error Dispersion
Mathematical quantification of how much the errors made by the subjects are spread between stimuli and responses
Measured: Weeks 1, 10, 14, 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start30 May 2022
- Primary completionOct 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deafness, BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cochlear
- Responsible party
- Sponsor
- Investigators
- Wendy Huinck, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307952
- Sponsor's protocol ID
- 2022-13495
- Acronym
- AuDiET
- Status last verified
- Jun 2023
- First submitted
- 10 Mar 2022
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to any researchers not involved in the project
Publications
Philpott N, Philips B, Wasmann JW, Migliorini E, van Dijk B, Mylanus EAM, Huinck WJ. Individualized home-based phoneme training for adult cochlear implant users reduces phoneme confusion errors. Cochlear Implants Int. 2025 Sep;26(5):363-373. doi: 10.1080/14670100.2025.2583654. Epub 2025 Nov 11.
PubMed 41219176
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory Diagnostics and Error-based Treatment
- ClinicalTrials.gov ID
- NCT05307952
- Acronym / sponsor ID
- AuDiET / 2022-13495
- Keywords
- Cochlear Implant, Speech Perception, Hearing, Speech, Prosthesis Fitting, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Cochlear
- Study start
- 30 May 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fitting and Training Intervention | Experimental | Diagnostic Test: Tone Audiometry, Diagnostic Test: Spectrotemporal Assessment, Diagnostic Test: Phoneme and Speech Perception, Diagnostic Test: Digit Triplet Test, Other: Personalized fitting, Behavioral: Personalized trainingAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tone AudiometryEvaluation of the participants' audiometrical thresholds | Diagnostic test | Fitting and Training Intervention |
| Spectrotemporal AssessmentEvaluation of the participants' promptness in detecting a modulation of a harmonic complex | Diagnostic test | Fitting and Training Intervention |
| Phoneme and Speech PerceptionEvaluation of the participants' understanding of phonemes and short words, both in quiet and in noise | Diagnostic test | Fitting and Training Intervention |
| Digit Triplet TestEvaluation of the participants' ability to discern speech in noise | Diagnostic test | Fitting and Training Intervention |
| Personalized fittingAdjustment of the parameters of the participants' cochlear implants aimed at improving their speech perception | Other | Fitting and Training Intervention |
| Personalized trainingSelf-administered training exercises focused on the speech components the participants are experiencing difficulties into | Behavioural | Fitting and Training Intervention |
Primary outcome
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.
2 secondary outcomes
Change in Distance-based Accuracy Score
Time frame: Weeks 1, 10, 14, 18
Change in Error Dispersion
Time frame: Weeks 1, 10, 14, 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Derived from this study: PubMed 41219176Philpott N, Philips B, Wasmann JW, Migliorini E, van Dijk B, Mylanus EAM, Huinck WJ. Individualized home-based phoneme training for adult cochlear implant users reduces phoneme confusion errors. Cochlear Implants Int. 2025 Sep;26(5):363-373. doi: 10.1080/14670100.2025.2583654. Epub 2025 Nov 11.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to any researchers not involved in the project
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Huinck, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tone Audiometry, Spectrotemporal Assessment and Phoneme and Speech Perception in people with Deafness, Bilateral and Deafness Neurosensory, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wendy Huinck, PhD (+31243613506, Wendy.Huinck@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percent Speech Recognition (time frame: Weeks 1, 10, 14, 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05307952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.