Hearing LossNCT02984748
Outcome Prediction in Cochlear Implant Recipients
An observational study of Hearing Loss, run by The Hearing Cooperative Research Centre at 1 site in Australia.
Trial summary
The ability to predict post-operative outcomes after implantation is important for a number of reasons, including being able to advise candidates of appropriate expectations using evidence based guidance. 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?
- Cochlear implant
- Type of treatment
- Medical device
- How many people
- 267 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Oct 2014to Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Cochlear Implant Recipients
Who may be able to join
- Clinical suitability for first side implantation, i.e. not undergoing assessment for second side cochlear implant surgery
- Willing and able to attend the study visits
- Able to provide informed consent for participation in the study, with an understanding of the requirements, risks and benefits of participation in the investigation
- Able to read and understand study documents and follow investigator instructions
- Able to understand and follow study personnel instructions during audiological measurements
- Native speaker in the language used to assess clinical speech perception performance
Who cannot join
- 1. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to enrolment in the clinical investigation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Outcomes in Adult Cochlear Implant Recipients
The ability to predict post-operative outcomes after implantation is important for a number of reasons, including being able to advise candidates of appropriate expectations using evidence based guidance. The approved study involves investigation of the ability to predict outcomes in the implanted ear alone and in the best-aided binaural listening conditions, examining a number of measured factors both pre-, peri- and post-operatively. The study incorporates a range of functional outcome measures through questionnaires to ascertain social, functional and demographic factors that may be predictive of outcomes. Questionnaires are also administered to determine the degree of benefit obtained after implantation for each individual, since this forms a key component of providing pre-operative counselling to candidates.
- Conditions
- Hearing Loss
- Being tested
- Cochlear implant
- Keywords
- cochlear implants, hearing loss
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantDevice
| Study group | Role | What they receive |
|---|---|---|
| Cochlear Implant Recipients | Not described Receives: Device: Cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech recognition in quiet
Speech recognition scores in quiet
Measured: Testing over 12 months
Speech recognition in noise
Speech recognition scores in noise
Measured: Testing over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start7 Oct 2014
- Primary completionMar 2019
- Study completionDec 2020
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hearing Cooperative Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Cochlear, Attune Hearing, Sydney Cochlear Implant Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984748
- Sponsor's protocol ID
- CLTD 5565
- Status last verified
- Jul 2021
- First submitted
- 4 Dec 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
- Prediction of Outcomes in Adult Cochlear Implant Recipients
- ClinicalTrials.gov ID
- NCT02984748
- Acronym / sponsor ID
- CLTD 5565
- Conditions
- Hearing Loss
- Keywords
- cochlear implants, hearing loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- The Hearing Cooperative Research CentreUniversity, hospital or other
- Collaborators
- Cochlear, Attune Hearing, Sydney Cochlear Implant Clinic
- Study start
- 7 Oct 2014 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 7 Dec 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.
The ability to predict post-operative outcomes after implantation is important for a number of reasons, including being able to advise candidates of appropriate expectations using evidence based guidance. The approved study involves investigation of the ability to predict outcomes in the implanted ear alone and in the best-aided binaural listening conditions, examining a number of measured factors both pre-, peri- and post-operatively. The study incorporates a range of functional outcome measures through questionnaires to ascertain social, functional and demographic factors that may be predictive of outcomes. Questionnaires are also administered to determine the degree of benefit obtained after implantation for each individual, since this forms a key component of providing pre-operative counselling to candidates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant Recipients | – | Device: Cochlear implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Cochlear Implant Recipients
Key inclusion criteria (6 listed)
- Clinical suitability for first side implantation, i.e. not undergoing assessment for second side cochlear implant surgery
- Willing and able to attend the study visits
- Able to provide informed consent for participation in the study, with an understanding of the requirements, risks and benefits of participation in the investigation
- Able to read and understand study documents and follow investigator instructions
- Able to understand and follow study personnel instructions during audiological measurements
Key exclusion criteria (1 listed)
- 1. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to enrolment 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 implant | Device | Cochlear Implant Recipients |
Primary outcome
Speech recognition in quiet
Time frame: Testing over 12 months
Speech recognition scores in quiet
Speech recognition in noise
Time frame: Testing over 12 months
Speech recognition scores in noise
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?
An observational study of 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 6 inclusion and 1 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?
Speech recognition in quiet (time frame: Testing over 12 months). 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.