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Trial record 1 of 1 for:    NCT04707885
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Clinical Utility of Residual Hearing in the Cochlear Implant Ear

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ClinicalTrials.gov Identifier: NCT04707885
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : June 1, 2022
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Oliver Adunka, Ohio State University

Brief Summary:
The current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI).

Condition or disease Intervention/treatment Phase
Hearing Loss, Sensorineural Hearing Loss Hearing Loss, Bilateral Device: Electrocochleography Not Applicable

Detailed Description:
The clinical importance of residual acoustic hearing in CI remains unclear. It is estimated that only five percent of adult candidates undergo CI. A major barrier is the loss of residual hearing associated with surgery, meaning most patients lose any or all residual hearing as a result of the CI surgery, especially since the majority of today's candidates do not suffer from complete deafness. Hence, many candidates are faced with the decision to relinquish their remaining acoustic hearing in exchange for electric hearing via the CI, as CI surgery often results in complete loss of any residual hearing. However, recent developments in hearing monitoring systems during CI surgery have shown promise for providing the surgeon with live feedback of how the cochlear implant insertion process is proceeding, allowing the surgeon to make intraoperative adjustments during the insertion, potentially minimizing any trauma caused by the insertion of the implant, ultimately helping preserve residual hearing. This ultimately could lead to improvements in the rates of hearing preservation. Therefore, the current study seeks to investigate: 1) the advantage of using a hearing monitoring system (electrocochleography) monitoring guided CI surgery on hearing preservation rates, 2) determine the benefit that hearing aid/cochlear implant combined hearing provides participants over non-hearing preservation CI (electric-only stimulation from the CI) on measures of speech perception and quality of life.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Actual Study Start Date : November 10, 2021
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ECochG monitoring
For those randomized to the experimental group, the CI surgery will proceed in a standard fashion. However, the surgeon will utilize ECochG-guided monitoring by placing the external device coil and processor over the receiver/stimulator of the implanted components. Also, a sound applicator (i.e. speaker) will be placed in the external auditory canal by the surgeon. During electrode insertion the surgeon will utilize the ECochG feedback to adjust insertion if needed. That is, once the electrode has been inserted at least 75% (75% of the electrode contacts inside the cochlea), the surgeon may proceed to full insertion if indicated during ECochG feedback or may modify and/or cease electrode insertion if indicated by the ECochG feedback in attempts to preserve RH.
Device: Electrocochleography

The use of ECochG monitoring will be employed. This will be conducted intraoperatively during the entire portion of the CI electrode insertion component.

For the purposes of this clinical trial, the stimulus will consist of a 500 Hz tone burst presented at ~105-110 dB SPL. This was chosen due to the time and resource limitations in the operating room. Hence, the surgical team can only utilize a very limited dataset for intraoperative decision making and previous studies have demonstrated that 500 Hz stimulation offers the most robust, reliable, and useful ECochG signal during electrode insertions.

Other Name: ECochG

No Intervention: Control Group
For those randomized to the control group, they will receive their CI per the standard of care. That is, all procedures that take place during a routine CI surgery will be the same for those in the control group. As such, no ECochG monitoring will be performed. However, all study surgeons will be asked to adhere to soft surgical principles (non-traumatic cochlear opening, slow electrode insertions) to enhance HP outcomes even in the absence of intraoperative ECochG monitoring. Further, the standard of care for cochlear implantation is to perform full electrode insertions with all electrode contacts inside of the cochlea. Thus, for subjects in the control group, surgeons will be asked to perform full electrode insertions.



Primary Outcome Measures :
  1. Preservation Advantage [ Time Frame: 3, 6, 12, 24 months ]
    Determine the hearing preservation advantage, by measuring low tone audiometry at the 3, 6,12 and 24 month timepoints, in hertz.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed and dated informed consent form.
  2. Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.
  3. Minimum of 30 days experience with appropriately fit binaural amplification (standardized National Acoustic Laboratories (NAL) fitting method) verified with real ear measurements within 5 dB SPL of targets.
  4. Limited benefit from conventional amplification in the best aided condition as defined by test scores of:

    1. The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct)
    2. Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct)
  5. Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted.
  6. Severe to profound mid to high-frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted.
  7. Low frequency PTA ≤ 55 dB HL sloping to moderately severe to profound mid-to high frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, 4000 Hz ≥ 60 dB) in the contralateral ear.
  8. Proficient in English.
  9. Undergoing implantation with a current generation CI device from either Cochlear Limited or Advanced Bionics AG.

    1. Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624
    2. Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala
  10. Stated willingness and ability to complete testing and all associated study visits.

Exclusion Criteria:

  1. Previous cochlear implantation.
  2. Prelingual onset of hearing loss.
  3. Abnormal inner ear anatomy on CT imaging.
  4. Auditory neuropathy spectrum disorder.
  5. Retrocochlear pathology such as a vestibular schwannoma or stroke.
  6. Unwillingness or inability to comply with all investigational requirements including the randomization process.
  7. Additional medical, or social barriers that would prevent completion of all study requirements.
  8. Medical condition contraindicated for surgery.
  9. Device selection of Med El CI (per the patient's selection).

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): NCT04707885


Contacts
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Contact: Beth Miles-Markley 614-366-9244 beth.miles-markley@osumc.edu
Contact: Meghan Hiss, AuD meghan.hiss@osumc.edu

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Camille Dunn, PhD       camille-dunn@uiowa.edu   
Principal Investigator: Bruce Gantz, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Paula Orr       orr.paula@mayo.edu   
Principal Investigator: Colin Driscoll, MD         
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Sarah Kukuljan       kukuljas@wustl.edu   
Principal Investigator: Amanda Ortmann, PhD         
United States, North Carolina
University of North Carolina, Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kevin Brown, MD       k_d_brown@med.unc.edu   
Principal Investigator: Kevin Brown, MD         
United States, Ohio
Ohio State University Eye and Ear Institute Recruiting
Columbus, Ohio, United States, 43210
Contact: Leah Kofmehl       leah.kofmehl@osumc.edu   
Principal Investigator: Edward Dodson, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Kenya Collins       kenya.collins.1@vumc.org   
Contact: Kelley Corcoran, AuD       kelley.corcoran@vumc.org   
Principal Investigator: Elizabeth Perkins, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Sarah Mleziva       smleziva@mcw.edu   
Principal Investigator: Michael Harris, MD         
Sponsors and Collaborators
Ohio State University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Oliver Adunka, MD Ohio State University
Principal Investigator: Amanda Ortmann, PhD Washington University School of Medicine
Publications:

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Responsible Party: Oliver Adunka, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT04707885    
Other Study ID Numbers: 2020H0477
U01DC018920-01 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases