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AB-Intra- and Post-Operative Measures of Auditory Function (AB-ECOG)

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ClinicalTrials.gov Identifier: NCT03685461
Recruitment Status : Completed
First Posted : September 26, 2018
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Michael Harris, Medical College of Wisconsin

Brief Summary:
The purpose of this study is to see how the inner ear responds to sound delivered to the ear canal during and after your cochlear implant surgery. This information may be helpful in telling us how well a cochlear implant performs after surgery.

Condition or disease Intervention/treatment Phase
Hearing Loss Cochlear Implant Other: Electrocochleography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Sample of cochlear implant recipients. Half randomized for observation with ECOchG on, half randomized to ECochG off
Masking: Double (Participant, Outcomes Assessor)
Masking Description: participant blinded to condition surgeon aware by necessity data reviewers blinded
Primary Purpose: Other
Official Title: AB-Intra- and Post-Operative Measures of Auditory Function
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : January 1, 2021
Actual Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Arm 1: Audible ECochG Response Off
Arm 1: Audible ECochG Response Off This condition is identical to the current standard-of-care for conventional CI surgery used worldwide. The surgeon will perform his or her electrode insertion without ECochG monitoring. Minute manipulations of the electrode are a normal part of conventional electrode insertion; manipulations such as redirecting the insertion vector or slowing down insertion speed will be made, as deemed necessary by the surgeon. A full electrode insertion will be performed, as appropriate. The ECochG responses will be recorded, but the surgeon will be blinded to this information during surgery.
Other: Electrocochleography
Electrocochleography is a noninvasive method of monitoring for acoustic evoked electrophysiologic responses from the cochlea. A speaker in the external auditory canal presents a tone burst stimulus and a nearby electrode, in this case from the apical electrode of the cochlear implant, records changes in the electrical activity within the cochlea. Different functional elements within the cochlea have signature electrophysiologic responses that can be isolated and studied individually. Through the use of intracochlear electrocochleography during cochlear implant electrode insertion valuable insight can be gained about structural or physiological changes that may be occurring.
Other Name: ECochG

Experimental: Arm 2: Audible ECochG Response On
This condition will have the audible ECochG response on and available to the surgeon. In this condition, the surgeon perform a conventional electrode insertion while listening to the running ECochG signal for drop in amplitude (suggesting impending trauma). If no drop is detected, insertion will proceed to the full electrode length according to the standard-of-care. If an ECochG amplitude drop is observed, the surgeon will place this observation in its clinical context and evaluate insertion parameters, (i.e., insertion vector, insertion speed, etc.), customary practice with conventional CI surgery, but here supplemented by the ECochG response. In the case of an ECochG amplitude drop that does not recover, the standard-of-care practice of achieving a full electrode insertion will be followed.
Other: Electrocochleography
Electrocochleography is a noninvasive method of monitoring for acoustic evoked electrophysiologic responses from the cochlea. A speaker in the external auditory canal presents a tone burst stimulus and a nearby electrode, in this case from the apical electrode of the cochlear implant, records changes in the electrical activity within the cochlea. Different functional elements within the cochlea have signature electrophysiologic responses that can be isolated and studied individually. Through the use of intracochlear electrocochleography during cochlear implant electrode insertion valuable insight can be gained about structural or physiological changes that may be occurring.
Other Name: ECochG




Primary Outcome Measures :
  1. The CI electrode's scalar position as indicated by post-operative computed tomography (CT) [ Time Frame: To be performed within one month of cochlear implantation ]
    Following cochlear implant surgery a CT scan, optimized for resolution of the CI electrode, will be obtained. This will be merged with routine clinically acquired pre-operative imaging to determine which of the scala the electrode sides in and whether or not there has been any translocation from one scala into another.


Secondary Outcome Measures :
  1. Post-operative hearing performance [ Time Frame: To be collected at post-op clinical visits until 12 months post-op ]
    Post-operative pure tone audiometry will be obtained and compared to preoperative pure tone audiometry to determine the degree of hearing preservation or loss of residual hearing that has been achieved.



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pure-tone audiometry thresholds ≤80 dB HL at 500 Hz
  • One year of age and older
  • Normal candidacy requirements for cochlear implantation met
  • No cochlear abnormality that might prevent full insertion of the CI electrode array
  • No additional handicap that would prevent study procedures from being followed

Exclusion Criteria:

  • Chronic otitis media
  • Malformed cochlea
  • Auditory neuropathy spectrum disorder (ANSD)
  • Presence of ear tubes
  • Prior middle ear surgeries or trauma including disruption of ossicles

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): NCT03685461


Locations
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United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
  Study Documents (Full-Text)

Documents provided by Michael Harris, Medical College of Wisconsin:
Study Protocol  [PDF] April 19, 2018
Informed Consent Form  [PDF] July 25, 2018

Publications:

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Responsible Party: Michael Harris, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03685461    
Other Study ID Numbers: PRO00032101
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Michael Harris, Medical College of Wisconsin:
Hearing Loss
Cochlear Implant
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases