Hearing Loss, SensorineuralNCT03756337
Neuro 1 vs. Neuro 2 Sound Processors
A study testing Neuro 1 & Neuro 2 and Neuro 2 & Neuro 1 in people with Hearing Loss, Sensorineural and Cochlear Hearing Loss, run by Oticon Medical at 1 site in Canada.
Trial summary
This study evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other half will be tested with Neuro 2 first and then Neuro 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural, Cochlear Hearing Loss
- What is being tested?
- Neuro 1 & Neuro 2 and Neuro 2 & Neuro 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2019to 10 Jan 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
- written informed consent
- primary implantation
- subject having participated to previous Neuro 1 sound processor study in Canada
- fluent in English, including reading and writing.
Who cannot join
- psychologically unsuitable
- unrealistic expectations regarding possible benefits, risks, and limitations that are inherent to the device
- non compliant with all investigational requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Audiometric Performance Between the Neuro 1 and Neuro 2 Sound Processors.
This study evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other half will be tested with Neuro 2 first and then Neuro 1.
Read the detailed description
The Neuro 1 processor represented a technological advancement over past models, particularly in detecting the environment and automatically adjusting to the sound environment. A second version of the Neuro 1 processor has been developed, the Neuro 2. The signal processing and stimulation characteristics are similar, so speech comprehension levels are expected to be equivalent. This study is designed to compare Neuro 1 and Neuro 2 in terms of audiometric performance.
- Conditions
- Hearing Loss, Sensorineural, Cochlear Hearing Loss
- Being tested
- Neuro 1 & Neuro 2, Neuro 2 & Neuro 1
- Keywords
- cochlear implant, sound processor, upgrade
- 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.
Neuro 1 & Neuro 2Device
participant common fitting map used for tests
Neuro 2 & Neuro 1Device
participant common fitting map used for tests
| Study group | Role | What they receive |
|---|---|---|
| Neuro 2 Upgrade | Experimental | Participant wears Neuro 1 sound processor and is tested, then is upgraded with the new sound processor Neuro 2 and tested. Receives: Device: Neuro 1 & Neuro 2 |
| Neuro 1 Downgrade | Experimental | Participant wears Neuro 2 sound processor and is tested, then is downgraded with the sound processor Neuro 1 and tested. Receives: Device: Neuro 2 & Neuro 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
speech recognition in quiet
Hearing In Noise Test
Measured: Day 1
Secondary outcomes (2)
speech recognition in noise
Hearing In Noise Test
Measured: Day 1
pure tone threshold
from 250Hz to 8kHz
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Nov 2019
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Peter Morris, MD, Principal investigator, Dalhousie University, Halifax,NS, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756337
- Sponsor's protocol ID
- PIC-20
- Status last verified
- Oct 2021
- First submitted
- 26 Nov 2018
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Audiometric Performance Between the Neuro 1 and Neuro 2 Sound Processors.
- ClinicalTrials.gov ID
- NCT03756337
- Acronym / sponsor ID
- PIC-20
- Conditions
- Hearing Loss, Sensorineural, Cochlear Hearing Loss
- Keywords
- cochlear implant, sound processor, upgrade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 28 Nov 2018 (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 study evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other half will be tested with Neuro 2 first and then Neuro 1.
Detailed description
The Neuro 1 processor represented a technological advancement over past models, particularly in detecting the environment and automatically adjusting to the sound environment. A second version of the Neuro 1 processor has been developed, the Neuro 2. The signal processing and stimulation characteristics are similar, so speech comprehension levels are expected to be equivalent. This study is designed to compare Neuro 1 and Neuro 2 in terms of audiometric performance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuro 2 Upgrade | Experimental | Device: Neuro 1 & Neuro 2Participant wears Neuro 1 sound processor and is tested, then is upgraded with the new sound processor Neuro 2 and tested. |
| Neuro 1 Downgrade | Experimental | Device: Neuro 2 & Neuro 1Participant wears Neuro 2 sound processor and is tested, then is downgraded with the sound processor Neuro 1 and tested. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- written informed consent
- primary implantation
- subject having participated to previous Neuro 1 sound processor study in Canada
- fluent in English, including reading and writing.
Key exclusion criteria (3 listed)
- psychologically unsuitable
- unrealistic expectations regarding possible benefits, risks, and limitations that are inherent to the device
- non compliant with all investigational requirements.
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 |
|---|---|---|
| Neuro 1 & Neuro 2participant common fitting map used for tests | Device | Neuro 2 Upgrade |
| Neuro 2 & Neuro 1participant common fitting map used for tests | Device | Neuro 1 Downgrade |
Primary outcome
speech recognition in quiet
Time frame: Day 1
Hearing In Noise Test
2 secondary outcomes
speech recognition in noise
Time frame: Day 1
pure tone threshold
Time frame: Day 1
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 20 Oct 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.
David Peter Morris, MD principal investigator
Dalhousie University, Halifax,NS, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro 1 & Neuro 2 and Neuro 2 & Neuro 1 in people with Hearing Loss, Sensorineural and Cochlear Hearing Loss, run by Oticon Medical at 1 site in Canada.
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 4 inclusion and 3 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 20 Oct 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 Canada. 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?
speech recognition in quiet (time frame: Day 1). 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 20 Oct 2021.