Auditory Diagnostics and Error-based Treatment (AuDiET)

Radboud University Medical Center

Status: Enrolling

Conditions: Deafness, Bilateral; Deafness Permanent; Deafness Neurosensory

Treatments: Diagnostic Test: Spectrotemporal Assessment; Diagnostic Test: Phoneme and Speech Perception; Diagnostic Test: Digit Triplet Test; Behavioral: Personalized training; Other: Personalized fitting; Diagnostic Test: Tone Audiometry

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05307952

2022-13495

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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, 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Fitting and Training Intervention

Experimental group

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.

Treatment:

Diagnostic Test: Phoneme and Speech Perception

Diagnostic Test: Spectrotemporal Assessment

Diagnostic Test: Tone Audiometry

Other: Personalized fitting

Behavioral: Personalized training

Diagnostic Test: Digit Triplet Test