Skip to content

Auditory Diagnostics and Error-based Treatment

Auditory Diagnostics and Error-based Treatment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05307952
Acronym
AuDiET
Enrollment
25
Registered
2022-04-01
Start date
2022-05-30
Completion date
2024-12-31
Last updated
2023-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deafness, Bilateral, Deafness Neurosensory, Deafness Permanent

Keywords

Cochlear Implant, Speech Perception, Hearing, Speech, Prosthesis Fitting, Rehabilitation

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.

Interventions

DIAGNOSTIC_TESTTone Audiometry

Evaluation of the participants' audiometrical thresholds

DIAGNOSTIC_TESTSpectrotemporal Assessment

Evaluation of the participants' promptness in detecting a modulation of a harmonic complex

DIAGNOSTIC_TESTPhoneme and Speech Perception

Evaluation of the participants' understanding of phonemes and short words, both in quiet and in noise

DIAGNOSTIC_TESTDigit Triplet Test

Evaluation of the participants' ability to discern speech in noise

OTHERPersonalized fitting

Adjustment of the parameters of the participants' cochlear implants aimed at improving their speech perception

BEHAVIORALPersonalized training

Self-administered training exercises focused on the speech components the participants are experiencing difficulties into

Sponsors

Cochlear
CollaboratorINDUSTRY
Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Percent Speech RecognitionWeeks 1, 10, 14, 18Given a list of CNC words, this score measures the percentage of correctly identified words.

Secondary

MeasureTime frameDescription
Change in Distance-based Accuracy ScoreWeeks 1, 10, 14, 18Speech 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 DispersionWeeks 1, 10, 14, 18Mathematical quantification of how much the errors made by the subjects are spread between stimuli and responses

Countries

Netherlands

Contacts

Primary ContactWendy Huinck, PhD
Wendy.Huinck@radboudumc.nl+31243613506

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026