Hearing Loss, SensorineuralNCT03143296
Reverberation Effects on MED-EL Recipients
A study testing Simulated reverberant environment in people with Hearing Loss, Sensorineural, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to investigate speech understanding in simulated reverberant environments with MED-EL cochlear implant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Simulated reverberant environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2018to 16 Apr 2021
- 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
- MED-EL current cochlear implant recipients of the Flex 24 or 28 will be included
- Minimum of 6 months experience with their cochlear implant
- Minimum of 10 new adult Med-El recipients of the Flex 24 or Flex 28 electrodes
- Patient at the University of Miami
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Department of Otolaryngology
Miami, Florida, 33175
About this study
Official title: The Effects of Reverberation on Speech Understanding in MED-EL Cochlear Implant Recipients
The purpose of this study is to investigate speech understanding in simulated reverberant environments with MED-EL cochlear implant recipients.
Read the detailed description
The study will determine if electrode length and coding strategy effect performance. The investigator will also study performance over time with new recipients.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Simulated reverberant environment
- 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.
Simulated reverberant environmentOther
Reverberant environments simulate real-life situations mimicking a living room, classroom and auditorium. Each simulation lasts up to 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Current recipient of a Med-El cochlear implant | Experimental | Participants who have received a MED-EL cochlear implant as a standard of care for treatment of hearing loss. Participants are tested at one time point with a simulated reverberant environment. Receives: Other: Simulated reverberant environment |
| Future Med-El Recipient | Active comparator | Cochlear implant candidates not yet implanted and chose Med-El device as standard of care for treatment of hearing loss. Participants are tested at 3 time points over 6 months in a simulated reverberant environment. Receives: Other: Simulated reverberant environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Performance
Speech performance recorded as percent correct compared to different electrode lengths.
Measured: Up to six months
Coding strategy
Speech scores, in percent correct, recorded from simulated reverberant speech tests will be compared between fine structure and envelope coding strategies.
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start16 Aug 2018
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Med-El Corporation
- Responsible party
- Principal investigator, Sandra Prentiss, University of Miami
- Investigators
- Sandra Prentiss, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143296
- Sponsor's protocol ID
- 20170198
- Status last verified
- Aug 2021
- First submitted
- 26 Apr 2017
- Last updated
- 26 Aug 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 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Reverberation on Speech Understanding in MED-EL Cochlear Implant Recipients
- ClinicalTrials.gov ID
- NCT03143296
- Acronym / sponsor ID
- 20170198
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Med-El Corporation
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 8 May 2017 (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.
The purpose of this study is to investigate speech understanding in simulated reverberant environments with MED-EL cochlear implant recipients.
Detailed description
The study will determine if electrode length and coding strategy effect performance. The investigator will also study performance over time with new recipients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current recipient of a Med-El cochlear implant | Experimental | Other: Simulated reverberant environmentParticipants who have received a MED-EL cochlear implant as a standard of care for treatment of hearing loss. Participants are tested at one time point with a simulated reverberant environment. |
| Future Med-El Recipient | Active comparator | Other: Simulated reverberant environmentCochlear implant candidates not yet implanted and chose Med-El device as standard of care for treatment of hearing loss. Participants are tested at 3 time points over 6 months in a simulated reverberant environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- MED-EL current cochlear implant recipients of the Flex 24 or 28 will be included
- Minimum of 6 months experience with their cochlear implant
- Minimum of 10 new adult Med-El recipients of the Flex 24 or Flex 28 electrodes
- Patient at the University of Miami
Key exclusion criteria (2 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
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 |
|---|---|---|
| Simulated reverberant environmentReverberant environments simulate real-life situations mimicking a living room, classroom and auditorium. Each simulation lasts up to 2 hours. | Other | Current recipient of a Med-El cochlear implant, Future Med-El Recipient |
Primary outcome
Speech Performance
Time frame: Up to six months
Speech performance recorded as percent correct compared to different electrode lengths.
Coding strategy
Time frame: Two hours
Speech scores, in percent correct, recorded from simulated reverberant speech tests will be compared between fine structure and envelope coding strategies.
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 26 Aug 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.
Sandra Prentiss, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated reverberant environment in people with Hearing Loss, Sensorineural, run by University of Miami at 1 site 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 4 inclusion and 2 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 26 Aug 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 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?
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 Performance (time frame: Up to six 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 26 Aug 2021.