Sensorineural Hearing Loss, BilateralNCT03904420
An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
A study testing Clinical Education and Treatment Model and Traditional Model in people with Sensorineural Hearing Loss, Bilateral, run by Cochlear at 2 sites in United States.
Trial summary
The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss, Bilateral
- What is being tested?
- Clinical Education and Treatment Model and Traditional Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Feb 2019to 29 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients who are receiving a Nucleus® CI512, CI522, or CI532 electrodes
- 18 years and older
- Postlingual onset of hearing loss (onset of hearing loss >two years of age)
- Individuals who qualify for cochlear implantation using the clinics current CI candidacy criteria
- Individuals who have recently been implanted but not yet had their external device activated
- Willingness to participate in a study and comply with all study requirements
- Fluent in spoken English
Who cannot join
- Ossification or any other cochlear anomaly that might prevent insertion of less than 10 electrodes of the electrode array
- Diagnosis of retro-cochlear pathology
- Diagnosis of auditory neuropathy
- Subject considering an acoustic component in the implanted ear
- Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
- Unwillingness or inability to comply with all investigational requirements
- Severe-profound sensorineural hearing loss >30 years
- Previous cochlear implant in the contralateral ear. Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the investigator
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Puget Sound ENT
Edmonds, Washington, 98026
Head and Neck Surgical Associates
Wichita Falls, Texas, 76310
About this study
The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Being tested
- Clinical Education and Treatment Model, Traditional Model
- 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.
Clinical Education and Treatment ModelOther
Patients will have self directed equipment education and standardized programming approaches
Traditional ModelOther
Standard clinical practice and education
| Study group | Role | What they receive |
|---|---|---|
| Group A - New Model | Experimental | Standardized programming and testing method Receives: Other: Clinical Education and Treatment Model |
| Group B - Traditional Model | Active comparator | Traditional clinical model which is not standardized across clinical sites Receives: Other: Traditional Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time Spent With Audiologist
Change in the overall number of minutes of cochlear implant appointments over the first 6 months post activation in the new model (Group A) compared to the traditional model (Group B).
Measured: 6 months post activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start26 Feb 2019
- Primary completion29 Oct 2019
- Study completion29 Oct 2019
Why it stopped: FDA determination of Fox software as class III medical device, not CDSS.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sensorineural Hearing Loss, BilateralStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904420
- Sponsor's protocol ID
- CAM5753
- Status last verified
- Oct 2020
- First submitted
- 3 Apr 2019
- Last updated
- 29 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
- ClinicalTrials.gov ID
- NCT03904420
- Acronym / sponsor ID
- CAM5753
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA determination of Fox software as class III medical device, not CDSS.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Posted 29 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - New Model | Experimental | Other: Clinical Education and Treatment ModelStandardized programming and testing method |
| Group B - Traditional Model | Active comparator | Other: Traditional ModelTraditional clinical model which is not standardized across clinical sites |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who are receiving a Nucleus® CI512, CI522, or CI532 electrodes
- 18 years and older
- Postlingual onset of hearing loss (onset of hearing loss >two years of age)
- Individuals who qualify for cochlear implantation using the clinics current CI candidacy criteria
- Individuals who have recently been implanted but not yet had their external device activated
Key exclusion criteria (8 listed)
- Ossification or any other cochlear anomaly that might prevent insertion of less than 10 electrodes of the electrode array
- Diagnosis of retro-cochlear pathology
- Diagnosis of auditory neuropathy
- Subject considering an acoustic component in the implanted ear
- Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic 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 |
|---|---|---|
| Clinical Education and Treatment ModelPatients will have self directed equipment education and standardized programming approaches | Other | Group A - New Model |
| Traditional ModelStandard clinical practice and education | Other | Group B - Traditional Model |
Primary outcome
Change in Time Spent With Audiologist
Time frame: 6 months post activation
Change in the overall number of minutes of cochlear implant appointments over the first 6 months post activation in the new model (Group A) compared to the traditional model (Group B).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Education and Treatment Model and Traditional Model in people with Sensorineural Hearing Loss, Bilateral, run by Cochlear at 2 sites 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 7 inclusion and 8 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 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 29 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Time Spent With Audiologist (time frame: 6 months post activation). 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 29 Oct 2020.