Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques

November 13, 2018 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cochlear Implant group - 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
Other: Vestibular testing
Patients who have received a cochlear implant within 90 days, and had vestibular testing pre-operatively, will undergo post-op vestibular testing
No Intervention: Control Group - existing historical vestibular data
This group will consist of existing historical vestibular testing data only. No subjects will be enrolled on this arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-Operatively, and then 3 months and 12 months post-operatively
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.
3 months and 12 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Erin Piker, AuD, PhD,, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

July 17, 2015

First Submitted That Met QC Criteria

July 17, 2015

First Posted (Estimate)

July 21, 2015

Study Record Updates

Last Update Posted (Actual)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00060216

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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