Auditory Diagnostics and Error-based Treatment

Not Applicable

Recruiting

• Conditions: Deafness, Bilateral; Deafness Permanent; Deafness Neurosensory
• Interventions: 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

• Registration Number: NCT05307952
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-04-01
• Study Start: 2022-05-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-05
• Primary Completion: 2023-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fitting and Training Intervention	Tone Audiometry	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.
Fitting and Training Intervention	Spectrotemporal Assessment	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.
Fitting and Training Intervention	Digit Triplet Test	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.
Fitting and Training Intervention	Personalized fitting	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.
Fitting and Training Intervention	Phoneme and Speech Perception	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.
Fitting and Training Intervention	Personalized training	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.

Primary Outcome Measures

Name	Time	Method
Change in Percent Speech Recognition	Weeks 1, 10, 14, 18	Given a list of CNC words, this score measures the percentage of correctly identified words.

Secondary Outcome Measures

Name	Time	Method
Change in Error Dispersion	Weeks 1, 10, 14, 18	Mathematical quantification of how much the errors made by the subjects are spread between stimuli and responses
Change in Distance-based Accuracy Score	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.

Trial Locations

Locations (1)

Radboud university medical center; 🇳🇱 Nijmegen, Gelderland, Netherlands