Electrocochleography Function for Monitoring Residual Hearing (ECochG)
Primary Purpose
Hearing Loss, Cochlear
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Electrocochleography
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss, Cochlear focused on measuring Cochlear Implant, Electrocochleography
Eligibility Criteria
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
Sites / Locations
- Hearing Implant Centre, Guy's and St Thomas' NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pilot Group
Arm Description
Intra and Post-operative Electrocochleography
Outcomes
Primary Outcome Measures
Cochlear Microphonic Amplitude (micro volts) via Electrocochleography during Cochlear Implant Insertion
Cochlear Microphonic amplitude from real time electrocochleography using the apical cochlear implant electrode during implant insertion.
Cochlear Microphonic Amplitude (micro volts) via Electrocochleography during post-operative audiological appointments
Cochlear Microphonic amplitude recorded from varying electrodes and at varying frequencies post-insertion during each follow-up appointment for the first year.
Secondary Outcome Measures
ECochG Correlations
Correlations between Intra and Post-operative cochlear microphonic amplitudes and other normal clinical measures (Impedance, eCAP, PTA, Speech)
Full Information
NCT ID
NCT03848338
First Posted
February 8, 2019
Last Updated
February 19, 2019
Sponsor
Guy's and St Thomas' NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03848338
Brief Title
Electrocochleography Function for Monitoring Residual Hearing
Acronym
ECochG
Official Title
Evaluation of Intra and Post-operative Electrocochleography for the Monitoring of Residual Hearing
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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:
Observed changes in this signal during surgery and residual hearing loss post-operatively and
Recordings of this signal post-operatively and actual pure tone audiometry results will also be assessed.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Cochlear
Keywords
Cochlear Implant, Electrocochleography
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pilot Group
Arm Type
Other
Arm Description
Intra and Post-operative Electrocochleography
Intervention Type
Procedure
Intervention Name(s)
Electrocochleography
Intervention Description
Electrocochleography measurement Intra-operatively and Post-operatively at follow-up appointments along with correlative measurements (Impedance, eCAP, PTA, Speech)
Primary Outcome Measure Information:
Title
Cochlear Microphonic Amplitude (micro volts) via Electrocochleography during Cochlear Implant Insertion
Description
Cochlear Microphonic amplitude from real time electrocochleography using the apical cochlear implant electrode during implant insertion.
Time Frame
1 Year
Title
Cochlear Microphonic Amplitude (micro volts) via Electrocochleography during post-operative audiological appointments
Description
Cochlear Microphonic amplitude recorded from varying electrodes and at varying frequencies post-insertion during each follow-up appointment for the first year.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
ECochG Correlations
Description
Correlations between Intra and Post-operative cochlear microphonic amplitudes and other normal clinical measures (Impedance, eCAP, PTA, Speech)
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew J Soulby, MSc
Phone
02071886245
Ext
6245
Email
Andrew.Soulby@gstt.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry B Nunn, MSc
Organizational Affiliation
Head of Audiology and Consultant Clinical Scientist
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan Jiang, PhD FRCS
Organizational Affiliation
Professor of Otology and Auditory Implantation Surgery.
Official's Role
Study Chair
Facility Information:
Facility Name
Hearing Implant Centre, Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terry B Nunn, MSc
Phone
02071886245
Ext
6245
Email
Terry.Nunn@gstt.nhs.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29434534
Citation
Dalbert A, Pfiffner F, Hoesli M, Koka K, Veraguth D, Roosli C, Huber A. Assessment of Cochlear Function during Cochlear Implantation by Extra- and Intracochlear Electrocochleography. Front Neurosci. 2018 Jan 26;12:18. doi: 10.3389/fnins.2018.00018. eCollection 2018.
Results Reference
background
PubMed Identifier
29867322
Citation
Pienkowski M, Adunka OF, Lichtenhan JT. Editorial: New Advances in Electrocochleography for Clinical and Basic Investigation. Front Neurosci. 2018 May 8;12:310. doi: 10.3389/fnins.2018.00310. eCollection 2018. No abstract available.
Results Reference
background
PubMed Identifier
27879487
Citation
Koka K, Saoji AA, Litvak LM. Electrocochleography in Cochlear Implant Recipients With Residual Hearing: Comparison With Audiometric Thresholds. Ear Hear. 2017 May/Jun;38(3):e161-e167. doi: 10.1097/AUD.0000000000000385.
Results Reference
background
PubMed Identifier
28611574
Citation
O'Connell BP, Holder JT, Dwyer RT, Gifford RH, Noble JH, Bennett ML, Rivas A, Wanna GB, Haynes DS, Labadie RF. Intra- and Postoperative Electrocochleography May Be Predictive of Final Electrode Position and Postoperative Hearing Preservation. Front Neurosci. 2017 May 29;11:291. doi: 10.3389/fnins.2017.00291. eCollection 2017.
Results Reference
background
PubMed Identifier
22291043
Citation
Mandala M, Colletti L, Tonoli G, Colletti V. Electrocochleography during cochlear implantation for hearing preservation. Otolaryngol Head Neck Surg. 2012 May;146(5):774-81. doi: 10.1177/0194599811435895. Epub 2012 Jan 30.
Results Reference
background
PubMed Identifier
33813521
Citation
Soulby A, Connor S, Jiang D, Nunn T, Boyle P, Pai I. Establishing Reproducibility and Correlation of Cochlear Microphonic Amplitude to Implant Electrode Position Using Intraoperative Electrocochleography and Postoperative Cone Beam Computed Tomography. Ear Hear. 2021 Sep/Oct;42(5):1263-1275. doi: 10.1097/AUD.0000000000001010.
Results Reference
derived
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Electrocochleography Function for Monitoring Residual Hearing
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