Sensory Hearing LossNCT02856659
Evaluation of N6 Sound Processor in Group of Freedom Users
An observational study of Sensory Hearing Loss, run by Cochlear.
Trial summary
Study of freedom sound processor users that upgrade to N6 sound processor CP900 series. To test speech understanding in each device and usability of upgrade. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sensory Hearing Loss
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jul 2016
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults and children 12 years of age and older.
Who may be able to join
- Subjects with sensorineural hearing loss
- 12 years of age and older
- Currently using Freedom Sound Processor
- Recipient of a Ci22M or CI24 series implant
- Minimum of 3 months experience with Freedom Sound Processor
- Prior documentation of sentence recognition in noise at a +10 SNR or better
- Native English speaker
- Willingness to participate and comply with requirements of protocol
Who cannot join
- Unable to complete test metrics
- Unrealistic expectations regarding possible benefits
- Additional handicaps that would prevent or restrict participation in audiological evaluations
- ABI cochlear implant recipient
About this study
Study of freedom sound processor users that upgrade to N6 sound processor CP900 series. To test speech understanding in each device and usability of upgrade.
- Conditions
- Sensory Hearing Loss
- Medical subject headings
- Hearing Loss, Sensorineural
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of N6 Sound Processor in Group of Freedom Users
Speech recognition measures in quiet \& noise via word and sentence rest and SSiQ questionnaire to compare freedom to upgrade with N6 relative to speech, spatial and quality dimensions and N6 questionnaire.
Measured: 3 months of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startSep 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Hearing LossStudies of the same condition, open and under way.
- More trials run by CochlearThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lori O'Neil, Au.D, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856659
- Sponsor's protocol ID
- CAM5623-FRN6
- Status last verified
- Jul 2016
- First submitted
- 29 Jul 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of N6 Sound Processor in Group of Freedom Users
- ClinicalTrials.gov ID
- NCT02856659
- Acronym / sponsor ID
- CAM5623-FRN6
- Conditions
- Sensory Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 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.
Study of freedom sound processor users that upgrade to N6 sound processor CP900 series. To test speech understanding in each device and usability of upgrade.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children 12 years of age and older.
Key inclusion criteria (8 listed)
- Subjects with sensorineural hearing loss
- 12 years of age and older
- Currently using Freedom Sound Processor
- Recipient of a Ci22M or CI24 series implant
- Minimum of 3 months experience with Freedom Sound Processor
Key exclusion criteria (4 listed)
- Unable to complete test metrics
- Unrealistic expectations regarding possible benefits
- Additional handicaps that would prevent or restrict participation in audiological evaluations
- ABI cochlear implant recipient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of N6 Sound Processor in Group of Freedom Users
Time frame: 3 months of use
Speech recognition measures in quiet \& noise via word and sentence rest and SSiQ questionnaire to compare freedom to upgrade with N6 relative to speech, spatial and quality dimensions and N6 questionnaire.
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 5 Aug 2016.
- Individual participant dataSharing planned: Yes
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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.
Lori O'Neil, Au.D study director
Cochlear
Questions about this trial
What is this clinical trial studying?
An observational study of Sensory Hearing Loss, run by Cochlear.
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 4 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 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluation of N6 Sound Processor in Group of Freedom Users (time frame: 3 months of use). 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 5 Aug 2016.