NCT05307952

Auditory Diagnostics and Error-based Treatment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-05-30
• Primary completion: 2023-10-01
• Completion: 2024-12-01
• First posted: 2022-04-01
• Last updated: 2023-07-05

Locations

1 site across 1 country: Netherlands