- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02503592
Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques
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
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Sponsor
Investigators
- Principal Investigator: Erin Piker, AuD, PhD,, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Vestibular Function in Cochlear Implant Patients
-
Assiut UniversityUnknownThe Difference in Estimation of Split Renal Function Using the Two Radiopharmaceuticals:Tc-99m DTPA & Tc-99m DMSA in Kidney Patients
-
University of PittsburghFogarty International Center of the National Institute of Health; University...CompletedEndothelial Function | Cardiovascular Disease Risk in HIV PatientsMalawi
-
Methodist Health SystemActive, not recruitingUse of Belatacept in Kidney Transplant PatientsUnited States
-
shaimaa MostafaCompletedAssessment of the RV Function in Patients With Heart Faliure
-
Fujian Provincial HospitalEnrolling by invitationOutcome | Cardiac Ultrasound Phenotypes | Septic Myocardial Suppression | Hyperdynamic State Left Ventricular Function in Sepsis PatientsChina
-
Ming ZhongNot yet recruitingTo Study the Incidence of Patient-ventilator Asynchronization in Two Groups of Patients Under Two Conditions With PVA Unsynchronization Analysis Function
-
Cairo UniversityCompletedTo Assess Erectile Function in Patients Complaining of Congenital Penile CurvatureEgypt
-
Taipei Medical UniversityTCI Co., Ltd.RecruitingEffects of Bacillus Coagulans TCI711 Supplementation on Liver and Gut Microbiota Function in Non-alcoholic Fatty Liver Disease PatientsTaiwan
-
University Hospital, GhentCompletedAutonomic Function in Patients With Chronic Obstructive Pulmonary DiseaseBelgium
-
Cairo UniversityRecruitingEffect of Piezo-surgical Implant With Laser on Pain and Swelling in Patients With Missing TeethEgypt
Clinical Trials on Vestibular testing
-
University Hospital, CaenRecruitingCerebrovascular Disorders | Developmental Disability | Brain Lesion | Degenerative DiseaseFrance
-
University of PittsburghUnited States Department of DefenseCompletedTraumatic Brain Injury (TBI)United States
-
Emory UniversityU.S. Army Medical Research and Development Command; General Electric; National... and other collaboratorsCompletedVestibular Neuritis | Mild Concussion | Post Concussion SyndromeUnited States
-
University College, LondonNIHR UCLH BRC; The Bernice Bibby Research TrustCompletedRare Diseases | Siderosis | Presbycusis | Neurological Disorder | Age Related Hearing LossUnited Kingdom
-
University of ZurichCompletedVerticality Perception in Healthy Human Subjects | Individual Contribution of Different Sensory SystemsSwitzerland
-
Neurovalens Ltd.University of California, San DiegoTerminatedObesity | Metabolic Syndrome | Weight Loss | Obesity, AbdominalUnited States
-
Ohio State UniversityNational Institute on Aging (NIA)Not yet recruitingHealthy AgingUnited States
-
Vest Brain,Centro de Estudios NeurovestibularesRecruitingBipolar Disorder | Depression, BipolarChile
-
Riphah International UniversityCompletedBenign Paroxysmal Positional VertigoPakistan
-
Massachusetts Eye and Ear InfirmaryOhio State University; University of Geneva, SwitzerlandCompletedVestibular Disorder | Vestibular Ataxia | Vestibular Loss, BilateralUnited States, Switzerland