Assessing auditory nerve degeneration by electrical stimulation in deaf patients with a cochlear implant

Completed

• Conditions: deafness; profound hearing loss; 10019243

• Registration Number: NL-OMON40195
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

Subjects eligible for participation in the study are adults with a CI.;In order to be eligible to participate in this study, a subject must meet all of the following criteria:
o Age >=18 years.
o Unilaterally implanted.
o Capable to provide an informed consent.
o The type of CI must be supported by the test equipment. Therefore only CI recipients with PULSARci100 or SONATAti100 implant, manufactured by MED-EL, can be included.
o More than half a year of CI experience (6 month post implantation).;Additional criterion for the high performance group:
o CVC scores with CI >70% measured at 65 dB SPL;Additional criterion for the low performance group:
o CVC scores with CI <50% measured at 65 dB SPL

Exclusion Criteria

• Neurological or mental disorders
• Use of anticonvulsant medication or psychotherapeutic drugs

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>difference between CI recipients with high and poor performance, with respect<br /><br>to detection thresholds, tone-decay time, melody recognition scores, and pulse<br /><br>rate detection limits.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To determine the range of test outcomes and clinical applicability for the<br /><br>three developed tests.<br /><br>• To determine if the outcome of the Melody test correlates to musical<br /><br>background.</p><br>