An interventional study of Tone Audiometry and Spectrotemporal Assessment in Deafness, Bilateral, Deafness Neurosensory and Deafness Permanent, sponsored by Radboud University Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-05.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
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.
609 studies on the registry are indexed under Deafness; 111 are open to participants now.
This study's planned enrollment of 25 is below the median of 40 across 411 interventional studies indexed under Deafness.
Browse Deafness studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 Audiometry · Diagnostic Test: Spectrotemporal Assessment · Diagnostic Test: Phoneme and Speech Perception · Diagnostic Test: Digit Triplet Test · Other: Personalized fitting · Behavioral: Personalized training
Evaluation of the participants' audiometrical thresholds
Evaluation of the participants' promptness in detecting a modulation of a harmonic complex
Evaluation of the participants' understanding of phonemes and short words, both in quiet and in noise
Evaluation of the participants' ability to discern speech in noise
Adjustment of the parameters of the participants' cochlear implants aimed at improving their speech perception
Self-administered training exercises focused on the speech components the participants are experiencing difficulties into
Change in Percent Speech Recognition
Given a list of CNC words, this score measures the percentage of correctly identified words.
Time frame: Weeks 1, 10, 14, 18
Change in Distance-based Accuracy Score
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.
Time frame: Weeks 1, 10, 14, 18
Change in Error Dispersion
Mathematical quantification of how much the errors made by the subjects are spread between stimuli and responses
Time frame: Weeks 1, 10, 14, 18
Plan to share: No — There is no plan to make IPD available to any researchers not involved in the project
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Radboud University Medical Center