cochlear implant deafness clinical trial tonotopy cochleair implantaat doofheid klinische trial tonotopie
Conditions
Interventions
Two interventions will be implemented during the study.
1. During the intensive CI-rehabilitation phase, mapping of the electrical input will be based on an individualized natural frequency alignment
Sponsors
Maastricht University Medical Center+
Eligibility
Inclusion criteria
Inclusion criteria: • Adult (18y or older) and meeting the conventional Dutch CI criteria; • Proficient speaker of Dutch language; • Post-lingual onset of profound deafness (> 4 years of age); • Subject receives an Advanced Bionics implant with Midscala electrode and an Advanced Bionics sound processor; • Prepared to use a study specific hearing aid (Phonak) for the duration of the study; • Rehabilitation at MUMC+ for the first year after surgery regarding CI as well as HA; • Active participation in trial related procedures such as daily randomization and regular testing.
Exclusion criteria
Exclusion criteria: • Physical or non-physical contraindications for MRI or CT imaging; • Additional disabilities that may prevent active participation and testing as per protocol. If there are indications that the mental abilities to comply with the study procedures are insufficient, additional screening will be performed with the Mini-Mental State Examination. Patients will be excluded from the study when the resulting score is lower than 24; • Cochlear or neural abnormalities that could affect outcome measures and/or compromise the placement of the electrode as assessed by the CI surgeon; • Active participation in another prospective clinical trial; • Pregnancy at time of imaging; • Requirement for electric-acoustic activation prior to the first year follow-up; • Having received a cochlear implant earlier (e.g. explantation or bilateral implantation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of natural place-pitched electric mapping, the following outcome measures will be compared between the new fitting strategy under investigation (Test) and the standard clinical fitting (Control): - Objective primary outcome: degree of speech understanding (words in quiet, sentences in quiet, sentences in noise) with CI during the first 6 months of rehabilitation. - Subjective primary outcome: patient preference in daily life for either the natural fitting or clinical fitting during the first 6 months of rehabilitation. with CI | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include objective and subjective measures to reflect biological response, performance, preference and sound quality: - Telemetric data on the function of the implant and the response of the auditory nerve. - Speech understanding with the contralateral HA (acoustic input) and bimodally (CI+HA) - Extended dimensions of sound perception (spatial masking, listening effort, sound quality, spectral resolution, loudness scaling). - Quality of life in relation to hearing ability. | — |
Contacts
Public ContactL. J. G. Lambriks
Maastricht UMC+, ENT/Audiological Centre
Outcome results
None listed