Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02466763
Other study ID # 15-000576
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date March 12, 2019

Study information

Verified date June 2019
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To the investigators' knowledge, no clinical study has prospectively investigated the relationship between surgical insertion technique, intracochlear electrode location, and postoperative hearing outcomes. To this end, the investigators are conducting a multicenter prospective randomized controlled double-blinded study comparing round window and cochleostomy cochlear implant electrode insertion.


Description:

Cochlear implant procedure has become the standard of care for patients with severe-to-profound sensorineural hearing loss. Successful outcomes are dependent on extrinsic and intrinsic factors. Significant predictive factors for hearing outcomes in patients with CIs have been previously reported. These include, but are not limited to, duration of deafness, level of preimplant speech recognition, pre/postlingual status, and the coupling of device electrodes. Recipient age does not appear to have a significant impact on hearing outcomes in elderly candidates.

A number of recent studies have proposed that intraoperative factors may be important determinants of electrode location and possibly of audiological outcome. Preliminary reports suggest that intracochlear electrode position- specifically, placement within the ST-is associated with improved audiological outcomes. Additionally, different surgical techniques have been proposed to minimize trauma during electrode insertion and to increase the likelihood of placement within the ST - namely round window and anteroinferior cochleostomy electrode insertion.

Currently, the best surgical approach for electrode insertion is highly debated, fueled by a lack of strong evidence to support one method over another. While a number of CI centers have begun to utilize a round window approach, many large volume centers in the United States and world wide continue to routinely employ cochleostomy electrode insertions. With an increasing number of patients being implanted with greater degrees of residual hearing, such data will become critical towards reducing intracochlear injury and optimizing patient outcomes. To the investigators' knowledge, no clinical study has prospectively investigated the relationship between surgical insertion technique, intracochlear electrode location, and postoperative hearing outcomes. To this end, the investigators are initiating a multicenter prospective randomized controlled double-blinded study comparing round window and cochleostomy cochlear implant electrode insertion.


Recruitment information / eligibility

Status Terminated
Enrollment 39
Est. completion date March 12, 2019
Est. primary completion date March 12, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria are:

- 18 years of age or older,

- less than a 10-year duration of deafness in the ear to be implanted,

- primary surgery,

- normal shaped cochleae,

- no retrocochlear pathology, and

- grossly normal cognitive function.

Exclusion criteria are:

- less than 18 years of age,

- prelingual deafness, or

- greater than 10-years duration of deafness in the ear to be implanted;

- prior otologic surgery in the implanted ear (excluding tympanostomy tube placement),

- inner ear malformation present in the ear to be implanted,

- retrocochlear pathology present in the auditory system to be implanted,

- developmental delay or known cognitive impairment, or

- pregnancy.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cochlear implant surgery
Surgical placement of a cochlear implant device.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cochlear implant electrode location after surgery a standard temporal bone CT scan will be used to show the location of the electrode in the cochlea about three months post op
Secondary Participant levels of speech perception standard audiometry speech perception tests will be administered Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively
Secondary Participant levels of word recognition scores standard audiometry CNC word score test will be administered Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively
Secondary Participant levels of sentence recognition scores standard audiometry AZBio sentence score test will be administered Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively
See also
  Status Clinical Trial Phase
Completed NCT05086809 - Investigation of an Updated Bone-anchored Sound Processor N/A
Withdrawn NCT02890576 - Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant COCHLESURV
Completed NCT01256229 - Outcomes In Children With Developmental Delay And Deafness Phase 1
Recruiting NCT04795986 - First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria
Recruiting NCT05867173 - Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces N/A
Completed NCT06104813 - Evaluation of Deaf Men's Knowledge About Sexual Health
Completed NCT04563884 - Validity of the French Version of Deafness Questionnaires for Children and Adolescents
Not yet recruiting NCT06088953 - EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER N/A
Completed NCT03980808 - American Sign Language-Accessible Diabetes Education N/A
Completed NCT03694340 - Optimization of Cochlear Implant MAP-parameters in Children N/A
Terminated NCT01959152 - Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode N/A
Completed NCT02539901 - Development of a Deaf Child With a Cochlear Implant. N/A
Completed NCT00511381 - Genetic Testing in Detection of Late-Onset Hearing Loss N/A
Withdrawn NCT00604474 - Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants N/A
Terminated NCT03867058 - Tradeoff Between Spatial and Temporal Resolution
Completed NCT01109576 - Workshops for Veterans With Vision and Hearing Loss Phase 0
Completed NCT01400178 - Cochlear Implants in Post-lingually Children: Results After 10 Years N/A
Completed NCT04106063 - A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children
Active, not recruiting NCT03352154 - Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants N/A
Recruiting NCT04495660 - Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS N/A

External Links