Hearing LossNCT02879539
Cochlear Implant Low Power Strategy
A study testing MP3000 sound coding strategy or ACE strategy with lower stimulation in people with Hearing Loss, run by The Hearing Cooperative Research Centre at 1 site in Australia.
Trial summary
Reducing power consumption in the cochlear implant is crucial to the development of future smaller sound processors. The commercial MP3000 sound coding strategy has been shown to be more efficient in power consumption to the standard ACE strategy. 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?
- MP3000 sound coding strategy or ACE strategy with lower stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 31 Mar 2015to 27 Jan 2017
- 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) cochlear implant recipients
- Implanted with the CI500, CI24RE and Nucleus 24 Series and CI422 cochlear implants.
- User of commercially available Freedom, CP810 or CP900 series sound processor
- User of the ACE strategy or MP3000 strategy
- At least 3 months experience with the cochlear implant
- 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: Clinical Assessment of a Low Power Strategy for Cochlear Implant Recipients
Reducing power consumption in the cochlear implant is crucial to the development of future smaller sound processors. The commercial MP3000 sound coding strategy has been shown to be more efficient in power consumption to the standard ACE strategy. However in order to develop smaller sound processors, further battery life power savings are required. The aim of this study is to evaluate three experimental sets of MP3000 parameter sets, compared against the default ACE program. In the background for each of the four strategies, experimental noise reduction programs (SpatialNR and NR3) will also be in use. In an additional phase of the study, low stimulation rate ACE programs will also be evaluated against the default stimulation rate.
- Conditions
- Hearing Loss
- Being tested
- MP3000 sound coding strategy or ACE strategy with lower stimulation
- Keywords
- cochlear implants, power consumption,
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP3000 sound coding strategy or ACE strategy with lower stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| MP3000-ACE strategy | Experimental | MP3000 sound coding strategy or ACE strategy with lower stimulation rate Receives: Device: MP3000 sound coding strategy or ACE strategy with lower stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Word recognition scores in quiet
Word recognition scores in quiet for i) MP3000 strategy compared to default ACE strategy and ii) lower rate stimulation for ACE strategy
Measured: Testing over 18 weeks
Sentence recognition scores in quiet
Sentence recognition scores in quiet for i) MP3000 strategy compared to ACE strategy and ii) lower rate stimulation for ACE strategy
Measured: Testing over 18 weeks
Secondary outcomes (3)
Fundamental frequency (F0) discrimination
F0 discrimination for MP3000 strategy compared to the ACE baseline
Measured: Testing over 18 weeks
Speech intelligibility and helpfulness subjective ratings
For MP3000 strategy compared to the default ACE baseline
Measured: Testing over 18 weeks
Sentence in noise scores
Comparison of MP3000 program with Spatial NR and NR3 enabled versus disabled.
Measured: Testing over 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start31 Mar 2015
- Primary completion27 Jan 2017
- Study completion27 Jan 2017
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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879539
- Sponsor's protocol ID
- CRC5607
- Status last verified
- Jul 2021
- First submitted
- 21 Aug 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
- Clinical Assessment of a Low Power Strategy for Cochlear Implant Recipients
- ClinicalTrials.gov ID
- NCT02879539
- Acronym / sponsor ID
- CRC5607
- Conditions
- Hearing Loss
- Keywords
- cochlear implants, power consumption,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Hearing Cooperative Research CentreUniversity, hospital or other
- Collaborators
- Royal Victoria Eye and Ear Hospital, Cochlear
- Study start
- 31 Mar 2015 (actual)
- Primary completion
- 27 Jan 2017 (actual)
- Study completion
- 27 Jan 2017 (actual)
- First posted
- 25 Aug 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.
Reducing power consumption in the cochlear implant is crucial to the development of future smaller sound processors. The commercial MP3000 sound coding strategy has been shown to be more efficient in power consumption to the standard ACE strategy. However in order to develop smaller sound processors, further battery life power savings are required. The aim of this study is to evaluate three experimental sets of MP3000 parameter sets, compared against the default ACE program. In the background for each of the four strategies, experimental noise reduction programs (SpatialNR and NR3) will also be in use. In an additional phase of the study, low stimulation rate ACE programs will also be evaluated against the default stimulation rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MP3000-ACE strategy | Experimental | Device: MP3000 sound coding strategy or ACE strategy with lower stimulationMP3000 sound coding strategy or ACE strategy with lower stimulation rate |
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) cochlear implant recipients
- Implanted with the CI500, CI24RE and Nucleus 24 Series and CI422 cochlear implants.
- User of commercially available Freedom, CP810 or CP900 series sound processor
- User of the ACE strategy or MP3000 strategy
- At least 3 months experience with the cochlear implant
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 |
|---|---|---|
| MP3000 sound coding strategy or ACE strategy with lower stimulation | Device | MP3000-ACE strategy |
Primary outcome
Word recognition scores in quiet
Time frame: Testing over 18 weeks
Word recognition scores in quiet for i) MP3000 strategy compared to default ACE strategy and ii) lower rate stimulation for ACE strategy
Sentence recognition scores in quiet
Time frame: Testing over 18 weeks
Sentence recognition scores in quiet for i) MP3000 strategy compared to ACE strategy and ii) lower rate stimulation for ACE strategy
3 secondary outcomes
Fundamental frequency (F0) discrimination
Time frame: Testing over 18 weeks
Speech intelligibility and helpfulness subjective ratings
Time frame: Testing over 18 weeks
Sentence in noise scores
Time frame: Testing over 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 MP3000 sound coding strategy or ACE strategy with lower stimulation 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Word recognition scores in quiet (time frame: Testing over 18 weeks). 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?
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.