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Intraoperative Multi-Frequency Electrocochleogram Monitoring

Hearing Preservation Cochlear Implant Surgery with Intraoperative Multi-Frequency Electrocochleogram Monitoring (DATAMAN) - Intraoperative Multi-Frequency Electrocochleogram Monitoring

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042240176
Enrollment
20
Registered
2025-01-28
Start date
2025-04-24
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

bilateral sensorineural hearing loss sensorineural hearing loss

Interventions

E01.370.520.510.500, E01.370.520.596.500, E04.510.500
Intraoperative Neurophysiological Monitoring

Sponsors

Yoshida Tadao
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients 18 years of age or older who meet the criteria for cochlear implantation or electric acoustic stimulation (2) Have residual hearing loss of 70 dB or less at least one frequency in the low frequency range (3) Patients who can understand the study and give written consent.

Exclusion criteria

Exclusion criteria: (1) Adults who lack sufficient judgment (2) Patients suffering from other psychiatric disorders (3) Patients who are judged by the principal investigator or subinvestigator to be inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Correlation between EcochG sweep (intraoperative, 3 months later) and postoperative (3 months later) pure tone hearing levels

Secondary

MeasureTime frame
Correlation between EcochG sweep (1, 6 months later) and postoperative (1,6 months later) pure tone hearing levels, Correlation between the number of drops above Amplitude 4 dB of intraoperative EcochG monitoring and pure tone hearing level at 3 months postoperatively, correlation between the maximum amplitude of intraoperative EcochG monitoring and electrode insertion length (correlation with estimation by OTOPLAN), change in DHI score before and after surgery, and change in cochlear vestibular symptoms (tinnitus, change in presence/absence of cochlear vestibular symptoms (tinnitus, vertigo, etc.) before and after surgery

Contacts

Public ContactTadao Yoshida

Nagoya university school of medicine (Nagoya university hospital)

tadaoy@med.nagoya-u.ac.jp+81-52-744-2323

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026