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Otocontrol: The Next Step.

Otocontrol-2.0: The Next Step. Towards optimal personalised fitting of cochlear implants. - Otocontrol-2.0: The next step

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58264
Enrollment
60
Registered
2025-07-03
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sensory hearing loss, deafness deafness

Interventions

Although in this study only patients are measured who have opted for the Advanced Bionics HiRes Cochleair Implant, the protocols and analyses of the research can at a later stage (in a follow-up study

Sponsors

Radboud Universiteit Nijmegen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Aged 18 or older and mentally competent• Selected for a new CI implant of the HiRes family with Marvel speech processor of Advanced Bionics.• Native Dutch speaker• Written informed consent

Exclusion criteria

Exclusion criteria: Disability that could interfere with the completion of the tests (e.g., psychiatric problems, or visually impaired) and prelingually deaf.

Design outcomes

Primary

MeasureTime frame
The primary research variables are the reaction times to perceived changes in spectrotemporally modulated sounds (STM-RT paradigm measured in the clinic and at home) and in direct electrical stimulation modulations of selected electrode pairs (TED-RT paradigm, performed in the clinic). From the STM-RT data, we deduce the patient's spectrotemporal sensitivity, and measure (in the clinic) the effects on the reaction times to changes in fitting; from the TED-RT data, together with electrophysiological data obtained intra-operatively (eCAP, transimpedance matrix, and eCochG), we assess the quality of signal transmission from individual electrodes and their interactions. Both datasets are crucial for better understanding, model, and predicting the variation in speech comprehension in noisy environments.

Secondary

MeasureTime frame
Visual reaction times provide important information about the idiosyncratic variation in reaction times between participants that is not caused by auditory function. The cognitive reading test and attention test offer valuable further insights into the patient’s short-term memory, which is also a contributing cognitive factor for speech comprehension in noisy environments.

Countries

Denmark, Germany, Netherlands

Contacts

Public ContactAJ Opstal

Radboud Universiteit Nijmegen

vanopstaljohn@gmail.com+316 4540 2191

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 10, 2026