An interventional study of Electrocochleography in Hearing Loss, Cochlear, sponsored by Guy's and St Thomas' NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-20.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Not applicable, Interventional, and Other
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:
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.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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.
Time frame: 1 Year
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.
Time frame: 1 Year
ECochG Correlations
Correlations between Intra and Post-operative cochlear microphonic amplitudes and other normal clinical measures (Impedance, eCAP, PTA, Speech)
Time frame: 1 Year
Plan to share: No
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Guy's and St Thomas' NHS Foundation Trust