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Clinical Trials/NCT02503592
NCT02503592
Completed
Not Applicable

Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques

Duke University1 site in 1 country16 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vestibular Function in Cochlear Implant Patients
Sponsor
Duke University
Enrollment
16
Locations
1
Primary Endpoint
Change in Quality of Life by questionnaire
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
October 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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

Study Sites (1)

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