Electrocochleography Function for Monitoring Residual Hearing
NCT ID: NCT03848338
Last Updated: 2019-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2019-01-24
2021-01-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Pilot Group
Intra and Post-operative Electrocochleography
Electrocochleography
Electrocochleography measurement Intra-operatively and Post-operatively at follow-up appointments along with correlative measurements (Impedance, eCAP, PTA, Speech)
Interventions
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Electrocochleography
Electrocochleography measurement Intra-operatively and Post-operatively at follow-up appointments along with correlative measurements (Impedance, eCAP, PTA, Speech)
Eligibility Criteria
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Inclusion Criteria
* 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
1 Year
ALL
Yes
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Terry B Nunn, MSc
Role: PRINCIPAL_INVESTIGATOR
Head of Audiology and Consultant Clinical Scientist
Dan Jiang, PhD FRCS
Role: STUDY_CHAIR
Professor of Otology and Auditory Implantation Surgery.
Locations
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Hearing Implant Centre, Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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214480
Identifier Type: -
Identifier Source: org_study_id
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