Auditory Diagnostics and Error-based Treatment

NCT05307952 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-07-05

No results posted yet for this study

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.

Conditions

  • Deafness, Bilateral
  • Deafness Neurosensory
  • Deafness Permanent

Interventions

DIAGNOSTIC_TEST

Tone Audiometry

Evaluation of the participants' audiometrical thresholds

DIAGNOSTIC_TEST

Spectrotemporal Assessment

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

DIAGNOSTIC_TEST

Phoneme and Speech Perception

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

DIAGNOSTIC_TEST

Digit Triplet Test

Evaluation of the participants' ability to discern speech in noise

OTHER

Personalized fitting

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

BEHAVIORAL

Personalized training

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

Sponsors & Collaborators

  • Cochlear

    collaborator INDUSTRY
  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Wendy Huinck, PhD · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-30
Primary Completion
2023-10-31
Completion
2024-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05307952 on ClinicalTrials.gov