Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques

NCT ID: NCT02503592

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-10-01

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).

Conditions

Vestibular Function in Cochlear Implant Patients

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Vestibular testing

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vestibular testing

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Piker, AuD, PhD,

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00060216

Identifier Type: -

Identifier Source: org_study_id