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Prospective Study of Round Window Versus Cochleostomy Approach to CI Surgery

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ClinicalTrials.gov Identifier: NCT02466763
Recruitment Status : Recruiting
First Posted : June 9, 2015
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew L. Carlson, M.D., Mayo Clinic

Brief Summary:

In 1985, the United States Food and Drug Administration (FDA) approved multichannel cochlear implants (CIs) for adults with profound hearing loss; and in 1990, implantation was approved for children. Since then, this procedure has become the standard of care for patients with severe-to-profound sensorineural hearing loss. Successful outcomes are dependent not only on extrinsic factors, but also on intrinsic factors that cannot always be modified by the CI team. 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.

Earlier studies have found that, because of its dimensions and proximity to the spiral ganglion cells, the scala tympani (ST) is the preferred location for CI electrode placement. 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.


Condition or disease Intervention/treatment Phase
Deafness Procedure: Cochlear implant surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Double-blinded Study Comparing Cochlear Implantation Through a Round Window Versus Cochleostomy Approach
Study Start Date : May 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: round window
Half of the participants will be randomized to the round window technique of cochlear implant device electrode insertion. Intervention for participants randomized to the round window arm include having the round window technique used for the electrode insertion during the participant's cochlear implant surgery. Participants in this arm of the study will also have a post operative CT scan at about three months after surgery.
Procedure: Cochlear implant surgery
Surgical placement of a cochlear implant device.

Active Comparator: cochleostomy
Half of the participants will be randomized to the cochleostomy technique of cochlear implant device electrode insertion. For the participants randomized to the cochleostomy arm, the surgeon will use a cochleostomy technique for the electrode insertion during the participant's cochlear implant surgery. Participants in this arm of the study will also have a post operative CT scan at about three months after surgery.
Procedure: Cochlear implant surgery
Surgical placement of a cochlear implant device.




Primary Outcome Measures :
  1. Cochlear implant electrode location after surgery [ Time Frame: about three months post op ]
    a standard temporal bone CT scan will be used to show the location of the electrode in the cochlea


Secondary Outcome Measures :
  1. Participant levels of speech perception [ Time Frame: Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively ]
    standard audiometry speech perception tests will be administered

  2. Participant levels of word recognition scores [ Time Frame: Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively ]
    standard audiometry CNC word score test will be administered

  3. Participant levels of sentence recognition scores [ Time Frame: Preoperatively, and at approximately 1 month, 3 months, 6 months, and 12 months postoperatively ]
    standard audiometry AZBio sentence score test will be administered



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466763


Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Nicole M Tombers, BS, RN    507-538-1392 ext 2    tombers.nicole@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Matthew Carlson, MD Mayo Clinic

Responsible Party: Matthew L. Carlson, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02466763     History of Changes
Other Study ID Numbers: 15-000576
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019

Keywords provided by Matthew L. Carlson, M.D., Mayo Clinic:
round window
cochlear implants
cochleostomy

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms