Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques
- Conditions
- Vestibular Function in Cochlear Implant Patients
- Interventions
- Other: Vestibular testing
- Registration Number
- NCT02503592
- Lead Sponsor
- Duke University
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- > 18 years of age
- Only patients implanted with the MED-EL CI device within the last 90 days will be eligible for this study.
- Patients < 18 years of age
- Patients implanted with a cochlear implant device other than MED-El CI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cochlear Implant group - Vestibular testing Vestibular testing 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
- Primary Outcome Measures
Name Time Method Change in Quality of Life by questionnaire 3 months and 12 months post-operatively Self-reported quality of life questionnaire (DHI) will be collected 3 months and 12 months post-operatively.
Change in Vestibular function in Cochlear Implant Patients 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States