Hearing Loss, SensorineuralNCT03382769
Hearing Loss in Older Adults Study
A study testing Cochlear implantation in people with Hearing Loss, Sensorineural and Hearing Loss, Bilateral, run by Cochlear at 8 sites in United States.
Trial summary
This is a prospective, 1:1 randomized controlled trial of immediate versus delayed cochlear implantation (CI) on hearing handicap, communicative function, loneliness, mental wellbeing, and cognitive functioning. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral
- What is being tested?
- Cochlear implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 8 sitesUnited States
- Study dates
- 27 Mar 2019to 4 Jan 2020
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Community-dwelling
- Proficient in English
- Oral communicator
- PTA (500, 1000 \& 2000 Hz) ≥ 70 dB HL hearing loss duration ≥1 and no more than 30 years
- Active daily hearing aid users
- HHIE-S score greater than or equal to 24
Show all 9Show fewer
- MoCA score greater than or equal to 20
- Post-linguistic onset sensorineural hearing loss and meet applicable FDA and/or Medicare candidacy criteria for cochlear implantation
- Willing to consent for the study, to be randomized to either group, to utilize bimodal hearing for the duration of the trial (if clinically appropriate), and follow the study protocol
Who cannot join
- Prelingual or perilingual severe-to-profound hearing loss
- Previous cochlear implantation in either ear
- Hearing loss of neural or central origin
- Permanent conductive hearing impairment (e.g. otosclerosis)
- Medical, audiological, or psychological conductions that might contraindicate participation in the clinical investigation
- Self reported disability in 2 or more activities of daily living
- Vision impairment worse than 20/40 on a near vision card
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
University of Cincinnati Health
Cincinnati, Ohio, 45219
Ohio State University
Columbus, Ohio, 43212
House Ear Institute
Los Angeles, California, 90057
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10029
Washington University
St Louis, Missouri, 63112
Arizona Center for Neurosciences
Tucson, Arizona, 85718
About this study
Official title: Hearing Loss in Older Adults: A Randomized Controlled Trial of Immediate Versus Delayed Cochlear Implantation.
This is a prospective, 1:1 randomized controlled trial of immediate versus delayed cochlear implantation (CI) on hearing handicap, communicative function, loneliness, mental wellbeing, and cognitive functioning. Participants are randomized 1:1 to an immediate cochlear implant intervention group versus a hearing aid control intervention.
- Being tested
- Cochlear implantation
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantationDevice
Unilateral implantation with a commercially approved Nucleus cochlear implant
| Study group | Role | What they receive |
|---|---|---|
| Group A (Immediate Cochlear Implantation) | Experimental | Group A will consist of 30 individuals who are candidates for cochlear implantation. They will be unilaterally implanted immediately after initial study testing has been completed and then be followed for 12 months after device activation. Receives: Device: Cochlear implantation |
| Group B (Delayed Cochlear Implantation) | Active comparator | Group B will consist of 30 individuals who are candidates for cochlear implantation. They will continue to wear hearing aids after enrolling in the study and then be unilaterally implanted 6 months after enrollment and followed for 6 more months after device activation. Receives: Device: Cochlear implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Handicap
The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item.
Assessment of the impact of cochlear implantation versus continued hearing aid is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing.
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start27 Mar 2019
- Primary completion4 Jan 2020
- Study completion4 Jan 2020
Why it stopped: Early terminated due to COVID-19 public health emergency, with a patient population in vulnerable populations (older adults) seeking cochlear implantation as elective Standard of Care.
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CogState Ltd., Syneos Health
- Responsible party
- Sponsor
- Investigators
- David N Cade, MD, MBA, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382769
- Sponsor's protocol ID
- CLTD5693
- Status last verified
- Nov 2022
- First submitted
- 19 Dec 2017
- Last updated
- 22 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Loss in Older Adults: A Randomized Controlled Trial of Immediate Versus Delayed Cochlear Implantation.
- ClinicalTrials.gov ID
- NCT03382769
- Acronym / sponsor ID
- CLTD5693
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early terminated due to COVID-19 public health emergency, with a patient population in vulnerable populations (older adults) seeking cochlear implantation as elective Standard of Care.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- CogState Ltd., Syneos Health
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 4 Jan 2020 (actual)
- Study completion
- 4 Jan 2020 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Posted 22 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, 1:1 randomized controlled trial of immediate versus delayed cochlear implantation (CI) on hearing handicap, communicative function, loneliness, mental wellbeing, and cognitive functioning. Participants are randomized 1:1 to an immediate cochlear implant intervention group versus a hearing aid control intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Immediate Cochlear Implantation) | Experimental | Device: Cochlear implantationGroup A will consist of 30 individuals who are candidates for cochlear implantation. They will be unilaterally implanted immediately after initial study testing has been completed and then be followed for 12 months after device activation. |
| Group B (Delayed Cochlear Implantation) | Active comparator | Device: Cochlear implantationGroup B will consist of 30 individuals who are candidates for cochlear implantation. They will continue to wear hearing aids after enrolling in the study and then be unilaterally implanted 6 months after enrollment and followed for 6 more months after device activation. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Community-dwelling
- Proficient in English
- Oral communicator
- PTA (500, 1000 \& 2000 Hz) ≥ 70 dB HL hearing loss duration ≥1 and no more than 30 years
- Active daily hearing aid users
Key exclusion criteria (7 listed)
- Prelingual or perilingual severe-to-profound hearing loss
- Previous cochlear implantation in either ear
- Hearing loss of neural or central origin
- Permanent conductive hearing impairment (e.g. otosclerosis)
- Medical, audiological, or psychological conductions that might contraindicate participation in the clinical investigation
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 |
|---|---|---|
| Cochlear implantationUnilateral implantation with a commercially approved Nucleus cochlear implant | Device | Group A (Immediate Cochlear Implantation), Group B (Delayed Cochlear Implantation) |
Primary outcome
Hearing Handicap
Time frame: 6 months after enrollment
The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. Assessment of the impact of cochlear implantation versus continued hearing aid is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- 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.
David N Cade, MD, MBA study director
Cochlear
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear implantation in people with Hearing Loss, Sensorineural and Hearing Loss, Bilateral, run by Cochlear at 8 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 9 inclusion and 7 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 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 22 Dec 2022). 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?
Hearing Handicap (time frame: 6 months after enrollment). 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 22 Dec 2022.