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Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques

Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02503592
Enrollment
16
Registered
2015-07-21
Start date
2015-04-30
Completion date
2018-10-01
Last updated
2018-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Function in Cochlear Implant Patients

Brief 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 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).

Interventions

OTHERVestibular testing

Patients who have received a cochlear implant within 90 days, and had vestibular testing pre-operatively, will undergo post-op vestibular testing

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \> 18 years of age * Only patients implanted with the MED-EL CI device within the last 90 days will be eligible for this study.

Exclusion criteria

* Patients \< 18 years of age * Patients implanted with a cochlear implant device other than MED-El CI

Design outcomes

Primary

MeasureTime frameDescription
Change in Vestibular function in Cochlear Implant PatientsPre-Operatively, and then 3 months and 12 months post-operativelyVestibular 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 questionnaire3 months and 12 months post-operativelySelf-reported quality of life questionnaire (DHI) will be collected 3 months and 12 months post-operatively.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026