Hearing Loss, CochlearECochGNCT03848338
Electrocochleography Function for Monitoring Residual Hearing
A study testing Electrocochleography in people with Hearing Loss, Cochlear, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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: 1. Observed changes in this signal during surgery and residual hearing loss post-operatively and 2. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Cochlear
- What is being tested?
- Electrocochleography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jan 2019to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Medically complex cases where minimal duration of surgery is required
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Hearing Implant Centre, Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Terry B Nunn, MSc, 02071886245 ext. 6245, Terry.Nunn@gstt.nhs.uk
About this study
Official title: 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:
- 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.
Read the 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.
- Conditions
- Hearing Loss, Cochlear
- Being tested
- Electrocochleography
- Keywords
- Cochlear Implant, Electrocochleography
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocochleographyProcedure or surgery
Electrocochleography measurement Intra-operatively and Post-operatively at follow-up appointments along with correlative measurements (Impedance, eCAP, PTA, Speech)
| Study group | Role | What they receive |
|---|---|---|
| Pilot Group | Other | Intra and Post-operative Electrocochleography Receives: Procedure: Electrocochleography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 Year
Secondary outcomes (1)
ECochG Correlations
Correlations between Intra and Post-operative cochlear microphonic amplitudes and other normal clinical measures (Impedance, eCAP, PTA, Speech)
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start24 Jan 2019
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, CochlearStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terry B Nunn, MSc, Principal investigator, Head of Audiology and Consultant Clinical ScientistDan Jiang, PhD FRCS, Study chair, Professor of Otology and Auditory Implantation Surgery.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848338
- Sponsor's protocol ID
- 214480
- Acronym
- ECochG
- Status last verified
- Feb 2019
- First submitted
- 8 Feb 2019
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29434534Pienkowski 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.
PubMed 29867322Koka 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.
PubMed 27879487O'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.
PubMed 28611574Mandala 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.
PubMed 22291043Soulby 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.
PubMed 33813521
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intra and Post-operative Electrocochleography for the Monitoring of Residual Hearing
- ClinicalTrials.gov ID
- NCT03848338
- Acronym / sponsor ID
- ECochG / 214480
- Conditions
- Hearing Loss, Cochlear
- Keywords
- Cochlear Implant, Electrocochleography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot Group | Other | Procedure: ElectrocochleographyIntra and Post-operative Electrocochleography |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Medically complex cases where minimal duration of surgery is required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrocochleographyElectrocochleography measurement Intra-operatively and Post-operatively at follow-up appointments along with correlative measurements (Impedance, eCAP, PTA, Speech) | Procedure or surgery | Pilot Group |
Primary outcome
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.
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 secondary outcome
ECochG Correlations
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Background: PubMed 29434534Dalbert 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.
- Background: PubMed 29867322Pienkowski 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.
- Background: PubMed 27879487Koka 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.
- Background: PubMed 28611574O'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.
- Background: PubMed 22291043Mandala 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.
- Derived from this study: PubMed 33813521Soulby 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry B Nunn, MSc principal investigator
Head of Audiology and Consultant Clinical Scientist
Dan Jiang, PhD FRCS study chair
Professor of Otology and Auditory Implantation Surgery.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocochleography in people with Hearing Loss, Cochlear, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew J Soulby, MSc (02071886245 ext. 6245, Andrew.Soulby@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cochlear Microphonic Amplitude (micro volts) via Electrocochleography during Cochlear Implant Insertion (time frame: 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03848338, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.