Completed

NCT Number: NCT02503592

Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques

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.

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Key information

Conditions

Vestibular Function in Cochlear Implant Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vestibular testing

Other

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Duke University