Electrocochleography Function for Monitoring Residual Hearing (ECochG)

February 19, 2019 updated by: Guy's and St Thomas' NHS Foundation Trust

Evaluation of Intra and Post-operative Electrocochleography for the Monitoring of Residual Hearing

This trial is a pilot study to assess the feasibility of using Electrocochleography recorded from a cochlear implant intra-operatively in real time to monitor the progress of its insertion. Correlation between:

  1. Observed changes in this signal during surgery and residual hearing loss post-operatively and
  2. Recordings of this signal post-operatively and actual pure tone audiometry results will also be assessed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Cochlear Implants (CIs) can provide deaf individuals the ability to hear. CIs are electronics packages inserted into the cochlea (hearing organ). An external processor digitises sound and transmits it to the implant. An electric stimulus from the implant mimics the change in electrical potential normally caused by the movement of stereocilia in the cochlea when a sound occurs. This change generates an impulse along the auditory nerve to the brain resulting in perception of sound.

CIs are available in the UK to people who have profound hearing loss. The improvement of CI technology means individuals with less significant losses, or profound losses at only some pitches may now benefit from a CI over a hearing aid. Patients having useful residual hearing has led to interest in better preserving that hearing during surgery. Thus allowing benefit from traditional acoustic amplification in addition to electrical stimulation from the implant.

The investigators propose recording a measurement via the implant during surgery and at audiology appointments called a cochlear microphonic using a technique called electrocochleography (ECochG). This is essentially recording the electrical signal generated by the movement of hair cells in the cochlea in response to a sound. It is hypothesised that reduction of this signal during implantation may correspond to cochlea damage occurring and that with development this signal might be useful feedback for surgeons. The signal is known to be correlated to actual hearing ability so a better understanding of this may allow us to fit the acoustic amplification portion of implants in individuals who are unable to respond reliably to a normal hearing test.

The purpose of this study is a pilot to assess the correlation between observed changes in this signal during surgery and residual hearing loss post-operatively and the degree correlation between recordings of this signal post-operatively and actual hearing test results.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • Hearing Implant Centre, Guy's and St Thomas' NHS Foundation Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meets normal candidacy requirements for cochlear implantation
  • At least 1 year of age at time of consent being given
  • Patent cochlea as verified by CT or MRI scan
  • No cochlear abnormality that might prevent insertion of the electrode array
  • Measurable residual hearing in the ear to be implanted
  • No additional complex needs that would prevent study procedures or normal clinical follow-up protocol being followed
  • AB Implant selected by patient or MDT
  • Written informed consent obtained

Exclusion Criteria:

  • Medically complex cases where minimal duration of surgery is required

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pilot Group
Intra and Post-operative Electrocochleography
Procedure: Electrocochleography
Electrocochleography measurement Intra-operatively and Post-operatively at follow-up appointments along with correlative measurements (Impedance, eCAP, PTA, Speech)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cochlear Microphonic Amplitude (micro volts) via Electrocochleography during Cochlear Implant Insertion
Time Frame: 1 Year
Cochlear Microphonic amplitude from real time electrocochleography using the apical cochlear implant electrode during implant insertion.
1 Year
Cochlear Microphonic Amplitude (micro volts) via Electrocochleography during post-operative audiological appointments
Time Frame: 1 Year
Cochlear Microphonic amplitude recorded from varying electrodes and at varying frequencies post-insertion during each follow-up appointment for the first year.
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ECochG Correlations
Time Frame: 1 Year
Correlations between Intra and Post-operative cochlear microphonic amplitudes and other normal clinical measures (Impedance, eCAP, PTA, Speech)
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Principal Investigator: Terry B Nunn, MSc, Head of Audiology and Consultant Clinical Scientist
  • Study Chair: Dan Jiang, PhD FRCS, Professor of Otology and Auditory Implantation Surgery.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

February 8, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 19, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 214480

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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