DeafnessNCT03870217
Comparing Site-selection Strategies
An observational study of Deafness, run by East Carolina University at 1 site in United States.
Trial summary
Several studies in the past have tried to deactivate electrodes that are less optimal to improve speech recognition outcomes. The study aims to compare the measures based on which the deactivation was performed. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deafness
- What is being tested?
- Site selection
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 4 Apr 2023
- Phase
- Observational
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children and adults with cochlear implants
Who may be able to join
- Native speakers of English
- Cochlear Nucleus cochlear implant users or Advanced Bionics users
- Postlingually deafened
- Has had device experience for at least one year
- Can be child or adult at the time of enrollment
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Communication Sciences and Disorders, ECU
Greenville, North Carolina, 27834
About this study
Official title: Comparing Site-selection Strategies for Improving Speech Recognition Outcomes
Several studies in the past have tried to deactivate electrodes that are less optimal to improve speech recognition outcomes. The study aims to compare the measures based on which the deactivation was performed. The investigators aim to first examine if the measures are strongly correlated each other, and then compare the deactivation effects across measures. These measures are mainly behavioral including electrode discrimination, amplitude modulation detection thresholds, low-rate and focused detection thresholds and electrode-modiolus distance. The endpoint of the study is speech recognition performance post deactivation.
- Conditions
- Deafness
- Being tested
- Site selection
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Site selectionBehavioural
Turning off electrodes on the electrode array based on imaging and psychophysical measures
| Study group | Role | What they receive |
|---|---|---|
| Cochlear implant users with Nucleus and AB devices | Speech recognition will be evaluated after poor electrodes are turned off. Receives: Behavioral: Site selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech recognition with deactivation
Electrodes will be evaluated based on (1) pitch discrimination (2) focused thresholds (3) amplitude modulation detection thresholds and (4) distances from the modious. Electrodes will be deactivated based on each of these measures and speech recognition will be evaluated to assess the effect of deactivation. The benefit of deactivation (speech recognition after deactivation minus before deactivation) will be derived for each measure. The measure that produces the greatest benefit will be identified.
Measured: 12 months post award notice and will take up to 3.5 years to complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Aug 2020
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Why it stopped: PI passed away. Ending grant and closing lab.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for DeafnessStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Wright, East Carolina University
- Investigators
- Ning Zhou, PHD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870217
- Sponsor's protocol ID
- Zhou_R01_study4
- Status last verified
- Jun 2024
- First submitted
- 5 Mar 2019
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Debruyne JA, Francart T, Janssen AM, Douma K, Brokx JP. Fitting prelingually deafened adult cochlear implant users based on electrode discrimination performance. Int J Audiol. 2017 Mar;56(3):174-185. doi: 10.1080/14992027.2016.1243262. Epub 2016 Oct 19.
PubMed 27758152Garadat SN, Zwolan TA, Pfingst BE. Using temporal modulation sensitivity to select stimulation sites for processor MAPs in cochlear implant listeners. Audiol Neurootol. 2013;18(4):247-60. doi: 10.1159/000351302. Epub 2013 Jul 20.
PubMed 23881208Nadol JB Jr. Patterns of neural degeneration in the human cochlea and auditory nerve: implications for cochlear implantation. Otolaryngol Head Neck Surg. 1997 Sep;117(3 Pt 1):220-8. doi: 10.1016/s0194-5998(97)70178-5.
PubMed 9334769Nadol JB Jr, Young YS, Glynn RJ. Survival of spiral ganglion cells in profound sensorineural hearing loss: implications for cochlear implantation. Ann Otol Rhinol Laryngol. 1989 Jun;98(6):411-6. doi: 10.1177/000348948909800602.
PubMed 2729822Noble JH, Labadie RF, Gifford RH, Dawant BM. Image-guidance enables new methods for customizing cochlear implant stimulation strategies. IEEE Trans Neural Syst Rehabil Eng. 2013 Sep;21(5):820-9. doi: 10.1109/TNSRE.2013.2253333. Epub 2013 Mar 19.
PubMed 23529109Seyyedi M, Viana LM, Nadol JB Jr. Within-subject comparison of word recognition and spiral ganglion cell count in bilateral cochlear implant recipients. Otol Neurotol. 2014 Sep;35(8):1446-50. doi: 10.1097/MAO.0000000000000443.
PubMed 25120196Zhou N. Monopolar Detection Thresholds Predict Spatial Selectivity of Neural Excitation in Cochlear Implants: Implications for Speech Recognition. PLoS One. 2016 Oct 31;11(10):e0165476. doi: 10.1371/journal.pone.0165476. eCollection 2016.
PubMed 27798658Zhou N. Deactivating stimulation sites based on low-rate thresholds improves spectral ripple and speech reception thresholds in cochlear implant users. J Acoust Soc Am. 2017 Mar;141(3):EL243. doi: 10.1121/1.4977235.
PubMed 28372106Zhou N, Pfingst BE. Psychophysically based site selection coupled with dichotic stimulation improves speech recognition in noise with bilateral cochlear implants. J Acoust Soc Am. 2012 Aug;132(2):994-1008. doi: 10.1121/1.4730907.
PubMed 22894220Zwolan TA, Collins LM, Wakefield GH. Electrode discrimination and speech recognition in postlingually deafened adult cochlear implant subjects. J Acoust Soc Am. 1997 Dec;102(6):3673-85. doi: 10.1121/1.420401.
PubMed 9407659Bierer JA, Litvak L. Reducing Channel Interaction Through Cochlear Implant Programming May Improve Speech Perception: Current Focusing and Channel Deactivation. Trends Hear. 2016 Jun 17;20:2331216516653389. doi: 10.1177/2331216516653389.
PubMed 27317668Srinivasan AG, Padilla M, Shannon RV, Landsberger DM. Improving speech perception in noise with current focusing in cochlear implant users. Hear Res. 2013 May;299:29-36. doi: 10.1016/j.heares.2013.02.004. Epub 2013 Mar 1.
PubMed 23467170
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Site-selection Strategies for Improving Speech Recognition Outcomes
- ClinicalTrials.gov ID
- NCT03870217
- Acronym / sponsor ID
- Zhou_R01_study4
- Conditions
- Deafness
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI passed away. Ending grant and closing lab.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 12 Mar 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.
Several studies in the past have tried to deactivate electrodes that are less optimal to improve speech recognition outcomes. The study aims to compare the measures based on which the deactivation was performed. The investigators aim to first examine if the measures are strongly correlated each other, and then compare the deactivation effects across measures. These measures are mainly behavioral including electrode discrimination, amplitude modulation detection thresholds, low-rate and focused detection thresholds and electrode-modiolus distance. The endpoint of the study is speech recognition performance post deactivation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear implant users with Nucleus and AB devices | – | Behavioral: Site selectionSpeech recognition will be evaluated after poor electrodes are turned off. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and adults with cochlear implants
Key inclusion criteria (5 listed)
- Native speakers of English
- Cochlear Nucleus cochlear implant users or Advanced Bionics users
- Postlingually deafened
- Has had device experience for at least one year
- Can be child or adult at the time of enrollment
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Site selectionTurning off electrodes on the electrode array based on imaging and psychophysical measures | Behavioural | Cochlear implant users with Nucleus and AB devices |
Primary outcome
Speech recognition with deactivation
Time frame: 12 months post award notice and will take up to 3.5 years to complete
Electrodes will be evaluated based on (1) pitch discrimination (2) focused thresholds (3) amplitude modulation detection thresholds and (4) distances from the modious. Electrodes will be deactivated based on each of these measures and speech recognition will be evaluated to assess the effect of deactivation. The benefit of deactivation (speech recognition after deactivation minus before deactivation) will be derived for each measure. The measure that produces the greatest benefit will be identified.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Background: PubMed 27758152Debruyne JA, Francart T, Janssen AM, Douma K, Brokx JP. Fitting prelingually deafened adult cochlear implant users based on electrode discrimination performance. Int J Audiol. 2017 Mar;56(3):174-185. doi: 10.1080/14992027.2016.1243262. Epub 2016 Oct 19.
- Background: PubMed 23881208Garadat SN, Zwolan TA, Pfingst BE. Using temporal modulation sensitivity to select stimulation sites for processor MAPs in cochlear implant listeners. Audiol Neurootol. 2013;18(4):247-60. doi: 10.1159/000351302. Epub 2013 Jul 20.
- Background: PubMed 9334769Nadol JB Jr. Patterns of neural degeneration in the human cochlea and auditory nerve: implications for cochlear implantation. Otolaryngol Head Neck Surg. 1997 Sep;117(3 Pt 1):220-8. doi: 10.1016/s0194-5998(97)70178-5.
- Background: PubMed 2729822Nadol JB Jr, Young YS, Glynn RJ. Survival of spiral ganglion cells in profound sensorineural hearing loss: implications for cochlear implantation. Ann Otol Rhinol Laryngol. 1989 Jun;98(6):411-6. doi: 10.1177/000348948909800602.
- Background: PubMed 23529109Noble JH, Labadie RF, Gifford RH, Dawant BM. Image-guidance enables new methods for customizing cochlear implant stimulation strategies. IEEE Trans Neural Syst Rehabil Eng. 2013 Sep;21(5):820-9. doi: 10.1109/TNSRE.2013.2253333. Epub 2013 Mar 19.
- Background: PubMed 25120196Seyyedi M, Viana LM, Nadol JB Jr. Within-subject comparison of word recognition and spiral ganglion cell count in bilateral cochlear implant recipients. Otol Neurotol. 2014 Sep;35(8):1446-50. doi: 10.1097/MAO.0000000000000443.
- Background: PubMed 27798658Zhou N. Monopolar Detection Thresholds Predict Spatial Selectivity of Neural Excitation in Cochlear Implants: Implications for Speech Recognition. PLoS One. 2016 Oct 31;11(10):e0165476. doi: 10.1371/journal.pone.0165476. eCollection 2016.
- Background: PubMed 28372106Zhou N. Deactivating stimulation sites based on low-rate thresholds improves spectral ripple and speech reception thresholds in cochlear implant users. J Acoust Soc Am. 2017 Mar;141(3):EL243. doi: 10.1121/1.4977235.
- Background: PubMed 22894220Zhou N, Pfingst BE. Psychophysically based site selection coupled with dichotic stimulation improves speech recognition in noise with bilateral cochlear implants. J Acoust Soc Am. 2012 Aug;132(2):994-1008. doi: 10.1121/1.4730907.
- Background: PubMed 9407659Zwolan TA, Collins LM, Wakefield GH. Electrode discrimination and speech recognition in postlingually deafened adult cochlear implant subjects. J Acoust Soc Am. 1997 Dec;102(6):3673-85. doi: 10.1121/1.420401.
- Background: PubMed 27317668Bierer JA, Litvak L. Reducing Channel Interaction Through Cochlear Implant Programming May Improve Speech Perception: Current Focusing and Channel Deactivation. Trends Hear. 2016 Jun 17;20:2331216516653389. doi: 10.1177/2331216516653389.
- Background: PubMed 23467170Srinivasan AG, Padilla M, Shannon RV, Landsberger DM. Improving speech perception in noise with current focusing in cochlear implant users. Hear Res. 2013 May;299:29-36. doi: 10.1016/j.heares.2013.02.004. Epub 2013 Mar 1.
- 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.
Ning Zhou, PHD principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deafness, run by East Carolina University at 1 site in United States.
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 5 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: withdrawn, as of the sponsor's last update on 28 Jun 2024. 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 States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech recognition with deactivation (time frame: 12 months post award notice and will take up to 3.5 years to complete). 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 NCT03870217, which also lists 12 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 28 Jun 2024.