Vestibular Function in Cochlear Implant PatientsNCT02503592
Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques
A study testing Vestibular testing in people with Vestibular Function in Cochlear Implant Patients, run by Duke University at 1 site in United States.
Trial summary
This study will measure the effects of soft surgical techniques on vestibular function and quality of life in patients pre- and post-cochlear implant (CI) surgery. Additionally, the investigators will attempt to systematically evaluate the utility of different electrophysiological measures of vestibular system… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Function in Cochlear Implant Patients
- What is being tested?
- Vestibular testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 1 Oct 2018
- 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
- > 18 years of age
- Only patients implanted with the MED-EL CI device within the last 90 days will be eligible for this study.
Who cannot join
- Patients < 18 years of age
- Patients implanted with a cochlear implant device other than MED-El CI
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
This study will measure the effects of soft surgical techniques on vestibular function and quality of life in patients pre- and post-cochlear implant (CI) surgery. Additionally, the investigators will attempt to systematically evaluate the utility of different electrophysiological measures of vestibular system function in surgical ears.
Vestibular system function in CI patients will be evaluated pre-surgically and twice post-surgically, at 3 months and again at 1 year post-surgery. Traditional test techniques - such as VNG, rotational testing, and air conduction VEMPs - will be compared to and cross-checked with newer techniques including video head impulse testing (vHIT) and bone conduction VEMPs.
Read the detailed description
Design \& Procedures: The current standard of care for CI patients includes a pre-op evaluation of the vestibular system. For this study, the investigators will compare subjects' routine pre-op test results to two additional post-op assessments performed for study purposes: one in the short term (~3 months post-op) and one in the long-term (~1 year post-op).
- Being tested
- Vestibular testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular testingOther
Patients who have received a cochlear implant within 90 days, and had vestibular testing pre-operatively, will undergo post-op vestibular testing
| Study group | Role | What they receive |
|---|---|---|
| Cochlear Implant group - Vestibular testing | Active comparator | Adult patients who have been implanted with a Med-El Cochlear implant device within the last 3 months who completed pre-op vestibular testing as standard of care. These subjects will undergo a series of post-op vestibular testing, at the 3 month and 12 month follow up visits Receives: Other: Vestibular testing |
| Control Group - existing historical vestibular data | No intervention | This group will consist of existing historical vestibular testing data only. No subjects will be enrolled on this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vestibular function in Cochlear Implant Patients
Vestibular system function in CI patients will be evaluated pre-surgically and twice post-surgically, at 3 months and again at 1 year post-surgery
Measured: Pre-Operatively, and then 3 months and 12 months post-operatively
Change in Quality of Life by questionnaire
Self-reported quality of life questionnaire (DHI) will be collected 3 months and 12 months post-operatively.
Measured: 3 months and 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startApr 2015
- Primary completion30 May 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular Function in Cochlear Implant PatientsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Piker, AuD, PhD,, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503592
- Sponsor's protocol ID
- Pro00060216
- Status last verified
- Nov 2018
- First submitted
- 17 Jul 2015
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques
- ClinicalTrials.gov ID
- NCT02503592
- Acronym / sponsor ID
- Pro00060216
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 21 Jul 2015 (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.
This study will measure the effects of soft surgical techniques on vestibular function and quality of life in patients pre- and post-cochlear implant (CI) surgery. Additionally, the investigators will attempt to systematically evaluate the utility of different electrophysiological measures of vestibular system function in surgical ears.
Vestibular system function in CI patients will be evaluated pre-surgically and twice post-surgically, at 3 months and again at 1 year post-surgery. Traditional test techniques - such as VNG, rotational testing, and air conduction VEMPs - will be compared to and cross-checked with newer techniques including video head impulse testing (vHIT) and bone conduction VEMPs.
Detailed description
Design \& Procedures: The current standard of care for CI patients includes a pre-op evaluation of the vestibular system. For this study, the investigators will compare subjects' routine pre-op test results to two additional post-op assessments performed for study purposes: one in the short term (~3 months post-op) and one in the long-term (~1 year post-op).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant group - Vestibular testing | Active comparator | Other: Vestibular testingAdult patients who have been implanted with a Med-El Cochlear implant device within the last 3 months who completed pre-op vestibular testing as standard of care. These subjects will undergo a series of post-op vestibular testing, at the 3 month and 12 month follow up visits |
| Control Group - existing historical vestibular data | No intervention | –This group will consist of existing historical vestibular testing data only. No subjects will be enrolled on this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > 18 years of age
- Only patients implanted with the MED-EL CI device within the last 90 days will be eligible for this study.
Key exclusion criteria (2 listed)
- Patients < 18 years of age
- Patients implanted with a cochlear implant device other than MED-El CI
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 |
|---|---|---|
| Vestibular testingPatients who have received a cochlear implant within 90 days, and had vestibular testing pre-operatively, will undergo post-op vestibular testing | Other | Cochlear Implant group - Vestibular testing |
Primary outcome
Change in Vestibular function in Cochlear Implant Patients
Time frame: Pre-Operatively, and then 3 months and 12 months post-operatively
Vestibular system function in CI patients will be evaluated pre-surgically and twice post-surgically, at 3 months and again at 1 year post-surgery
Change in Quality of Life by questionnaire
Time frame: 3 months and 12 months post-operatively
Self-reported quality of life questionnaire (DHI) will be collected 3 months and 12 months post-operatively.
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 15 Nov 2018.
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.
Erin Piker, AuD, PhD, principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular testing in people with Vestibular Function in Cochlear Implant Patients, run by Duke University 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 2 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 15 Nov 2018. 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?
Change in Vestibular function in Cochlear Implant Patients (time frame: Pre-Operatively, and then 3 months and 12 months post-operatively). 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 15 Nov 2018; AzTrials last refreshed its copy on 28 Oct 2026.