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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.5 years study duration

First Submitted

Initial submission to the registry

March 10, 2022

Completed

22 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed

2 months until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed

Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

1.3 years

First QC Date

March 10, 2022

Last Update Submit

June 30, 2023

Conditions

Deafness, Bilateral Deafness Neurosensory Deafness Permanent

Keywords

Cochlear ImplantSpeech PerceptionHearingSpeechProsthesis FittingRehabilitation

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

Change in Distance-based Accuracy Score
Weeks 1, 10, 14, 18
Change in Error Dispersion
Weeks 1, 10, 14, 18

Study Arms (1)

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.

Diagnostic Test: Tone AudiometryDiagnostic Test: Spectrotemporal AssessmentDiagnostic Test: Phoneme and Speech PerceptionDiagnostic Test: Digit Triplet TestOther: Personalized fittingBehavioral: Personalized training