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Measuring of electrically evoked compound action potentials (eCAP) and electrically evoked auditory brainstem responses (eABR) simultaneously

Measuring of electrically evoked compound action potentials (eCAP) and electrically evoked auditory brainstem responses (eABR) simultaneously - ART-ABR

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00035896
Enrollment
20
Registered
2025-01-14
Start date
2025-04-01
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

H83

Interventions

Group 1: Patients with indication for CI Planned Measurements: - eCAP measurement on one channel - eABR measurement with threshold on one channel - eCAP-ABR on one channel

Sponsors

Firma MED-EL Elektromedizinische Geräte Deutschland GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Signed and dated informed consent before the start of any study-specific procedure - Subjects who undergo CI surgery or subjects who are CI-users. - Age of subjects: older than 18 years old when the ICF is signed - The implant shall be SYNCHRONY2

Exclusion criteria

Exclusion criteria: - Lack of compliance with any inclusion criteria - Pregnant and/or nursing women - Participation in pharmacological clinical trials within four weeks prior to enrolment - Unrealistic expectation concerning personal benefits related to study participation and the results of the study

Design outcomes

Primary

MeasureTime frame
Correlation between eCAP and eABR threshold

Secondary

MeasureTime frame
- Time advantage compared to eCAP and eABR - Useability aspects (manual vs. automatic recording)

Countries

Germany

Contacts

Public ContactFlorian Schmidt

Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie "Otto Körner"

florian.schmidt@med.uni-rostock.de03814948374

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026