Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques

Duke University

Status: Completed

Conditions: Vestibular Function in Cochlear Implant Patients

Treatments: Other: Vestibular testing

Study type: Interventional

Funder types: Other

Identifiers

NCT02503592

Pro00060216

Details and patient eligibility

About

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.

Full 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).

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Cochlear Implant group - Vestibular testing

Active Comparator group

Description:

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

Treatment:

Other: Vestibular testing

Control Group - existing historical vestibular data

No Intervention group

Description:

This group will consist of existing historical vestibular testing data only. No subjects will be enrolled on this arm.