Hearing LossNCT02765386
Optimisation of Hybrid Fittings for Cochlear Implant Recipients
A study testing Hybrid fittings for cochlear implant recipients in people with Hearing Loss, run by The Hearing Cooperative Research Centre at 1 site in Australia.
Trial summary
When providing amplification post-implantation to residual acoustic hearing in the implanted ear, the lower frequency boundary can be modified to minimize or avoid overlap between the frequencies coded through acoustic hearing and those presented through electrical stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hybrid fittings for cochlear implant recipients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Oct 2015to 8 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 years of age)
- Post-operative residual hearing in the implanted ear (defined as having an unaided threshold better than or equal to 80 dB HL at the 500 Hz frequency).
- Implanted with the CI500 or CI24RE-series cochlear implants
- User of the commercially available Nucleus 6 sound processor
- User of the ACE strategy
- Native speaker in the language used to assess speech perception performance
- Willingness to participate in and to comply with all requirements of the protocol
Who cannot join
- Additional handicaps that would prevent participation in evaluations
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimisation of Hybrid Fittings for Newly Implanted Cochlear Implant Recipients
When providing amplification post-implantation to residual acoustic hearing in the implanted ear, the lower frequency boundary can be modified to minimize or avoid overlap between the frequencies coded through acoustic hearing and those presented through electrical stimulation. This boundary is termed the cross-over frequency (Fc) and the effect of modifying this parameter will be investigated in this study. To avoid the research being confounded by prior bias for a particular frequency allocation, the study will be conducted with newly implanted recipients.
This study will also investigate whether tests which measure the ability to use low frequency hearing and objective measures can predict the preferred Fc and speech performance benefit.
- Conditions
- Hearing Loss
- Being tested
- Hybrid fittings for cochlear implant recipients
- Keywords
- Cochlear implants, Hybrid fittings, Cross-over frequency
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid fittings for cochlear implant recipientsDevice
| Study group | Role | What they receive |
|---|---|---|
| Cochlear Implant Recipients | Experimental | Newly implanted cochlear implant recipients with post-implantation acoustic hearing. Receives: Device: Hybrid fittings for cochlear implant recipients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech, Spatial and Qualities of Hearing (SSQ) scale
Preference rating assessed using SSQ scale
Measured: Testing at 18, 19, 22 and 25 weeks post-activation of cochlear implant
Word recognition scores in quiet
Open-set monosyllabic word scores in quiet
Measured: Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant
Speech recognition in noise
Open-set speech recognition in noise
Measured: Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start7 Oct 2015
- Primary completion19 Sep 2018
- Study completion8 May 2020
Why it stopped: After several years of trying to recruit participants, it was decided to stop the study after recruiting only 12 participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hearing Cooperative Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Victoria Eye and Ear Hospital, Cochlear, University of Melbourne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765386
- Sponsor's protocol ID
- CRC5610
- Status last verified
- Jul 2021
- First submitted
- 14 Apr 2016
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Hybrid Fittings for Newly Implanted Cochlear Implant Recipients
- ClinicalTrials.gov ID
- NCT02765386
- Acronym / sponsor ID
- CRC5610
- Conditions
- Hearing Loss
- Keywords
- Cochlear implants, Hybrid fittings, Cross-over frequency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After several years of trying to recruit participants, it was decided to stop the study after recruiting only 12 participants.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Hearing Cooperative Research CentreUniversity, hospital or other
- Collaborators
- Royal Victoria Eye and Ear Hospital, Cochlear, University of Melbourne
- Study start
- 7 Oct 2015 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 6 May 2016 (estimated)
- 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.
When providing amplification post-implantation to residual acoustic hearing in the implanted ear, the lower frequency boundary can be modified to minimize or avoid overlap between the frequencies coded through acoustic hearing and those presented through electrical stimulation. This boundary is termed the cross-over frequency (Fc) and the effect of modifying this parameter will be investigated in this study. To avoid the research being confounded by prior bias for a particular frequency allocation, the study will be conducted with newly implanted recipients.
This study will also investigate whether tests which measure the ability to use low frequency hearing and objective measures can predict the preferred Fc and speech performance benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant Recipients | Experimental | Device: Hybrid fittings for cochlear implant recipientsNewly implanted cochlear implant recipients with post-implantation acoustic hearing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult (≥18 years of age)
- Post-operative residual hearing in the implanted ear (defined as having an unaided threshold better than or equal to 80 dB HL at the 500 Hz frequency).
- Implanted with the CI500 or CI24RE-series cochlear implants
- User of the commercially available Nucleus 6 sound processor
- User of the ACE strategy
Key exclusion criteria (2 listed)
- Additional handicaps that would prevent participation in evaluations
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device
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 |
|---|---|---|
| Hybrid fittings for cochlear implant recipients | Device | Cochlear Implant Recipients |
Primary outcome
Speech, Spatial and Qualities of Hearing (SSQ) scale
Time frame: Testing at 18, 19, 22 and 25 weeks post-activation of cochlear implant
Preference rating assessed using SSQ scale
Word recognition scores in quiet
Time frame: Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant
Open-set monosyllabic word scores in quiet
Speech recognition in noise
Time frame: Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant
Open-set speech recognition in noise
Results and safety
The study was stopped early (reason given: After several years of trying to recruit participants, it was decided to stop the study after recruiting only 12 participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid fittings for cochlear implant recipients in people with Hearing Loss, run by The Hearing Cooperative Research Centre at 1 site in Australia.
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 7 inclusion and 2 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: stopped early, as of the sponsor's last update on 6 Jul 2021. 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 Australia. 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 stopped early (reason given: After several years of trying to recruit participants, it was decided to stop the study after recruiting only 12 participants.). Results are not available in the source record.
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, Spatial and Qualities of Hearing (SSQ) scale (time frame: Testing at 18, 19, 22 and 25 weeks post-activation of cochlear implant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2021.