NCT06306534

Brief Summary

This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

January 15, 2025

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

February 28, 2024

Last Update Submit

January 13, 2025

Conditions

Auditory; Nerve

Outcome Measures

Primary Outcomes (1)

  • Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms

    4 weeks

Secondary Outcomes (1)

  • Collection of adverse events

    4 weeks

Study Arms (1)

Insert Array Into Auditory Nerve

EXPERIMENTAL
Other: Auditory Nerve Acute (ANA) Electrode Array

Interventions

Auditory Nerve Acute (ANA) Electrode ArrayOTHER

To measure eABRs when stimulating the human auditory nerve

Insert Array Into Auditory Nerve

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Patients who will undergo an acoustic neuroma removal surgery and are functional deaf
  • Age ≥ 18 years
  • Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gyncecologists

You may not qualify if:

  • Disabilities in addition to hearing impairment which might interfere with the study procedure
  • Pregnant and breast feeding woman or other vulnerable population

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

RECRUITING

MeSH Terms

Conditions

Vestibulocochlear Nerve Diseases

Condition Hierarchy (Ancestors)

Retrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesCranial Nerve DiseasesNervous System Diseases

Study Officials

  • Thomas Lenarz, Prof. Prof. Dr.

    Hannover Medical School, Director of otorhinolaryngology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl-Heinz Dyballa

CONTACT

+4917615328589dyballa.karl-heinz@mh-hannover.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 12, 2024

Study Start

May 15, 2023

Primary Completion

March 15, 2025

Study Completion

March 15, 2025

Last Updated

January 15, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)