Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation

November 18, 2024 updated by: Restorear Devices LLC

Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation

The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are:

  1. Is mild therapeutic hypothermia safe for use during cochlear implantation?
  2. Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation?

Participants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cochlear implants (CI) have dramatically changed the treatment and prognosis for patients with severe to profound sensorineural hearing loss. With the recent advent of electro-acoustic stimulation (EAS), the combined acoustic amplification at low frequencies with electrical stimulation of high frequency cochlear regions promises to benefit patients with even partial residual hearing by improving difficult listening situations like speech-in-noise and music appreciation. Unfortunately, trauma associated with the implant surgery results in inflammation, mechanical and vascular damage, and loss of remaining sensory hair cells (HC) and neurons. As a result, more than 44% of EAS patients lose residual hearing post-CI surgery and the residual hearing deteriorates by more than 30 dB over time in a majority of patients. This loss of residual hearing post-CI surgery has been the primary barrier for an extended application of CI/EAS.

This clinical trial will evaluate a novel mild therapeutic hypothermia device as an effective therapy to preserve residual hearing post-CI. This system does not require modification of the current surgery or CI devices and will deliver localized, controlled mild hypothermia to the sensitive inner ear structures. With preclinical published results, the investigators have already shown that localized hypothermia during CI surgery is highly effective and safe for residual hearing preservation. Here, the investigators will investigate the implementation of a therapy that benefits patients undergoing CI by improving post-surgical audiological outcomes. Extensive prior commercialization and development experience, intellectual property and engineering expertise coupled with the investigators' collaborators' clinical expertise in Otolaryngology and Audiology will ensure the successful clinical and commercial outcome of this therapy.

Overall, the aim of this clinical trial is:

Validate the clinical applicability, safety and efficacy of the system and device assembly for preservation of residual hearing after CI surgery. The device and hypothermia delivery system will be tested on adult patients undergoing CI surgery at the University of Miami. For clinical translation, the investigators aim to demonstrate that the application of hypothermia combined with the current standard of care for cochlear implantation for residual hearing preservation (steroids) is effective. The investigators hypothesize that the hypothermia application will not negatively impact CI function in patients (safety) and will improve early audiologic outcomes (efficacy) compared to the current standard of care in CI surgeries. The investigators will utilize clinically relevant pre-surgical, intra-operative and post-surgical measures in groups of patients receiving the standard of care and hypothermia therapy.

Preliminary and published preclinical data, and an existing system and device have been constructed for this clinical trial. The proposed therapy and device design for CI surgeries represent a non-pharmaceutical therapeutic strategy to preserve residual hearing.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
        • Contact:
        • Contact:
          • Suhrud M Rajguru, Ph.D.
        • Contact:
          • Michael Hoffer, M.D.
        • Contact:
          • Fred Telischi, M.D.
        • Contact:
          • Simon Angeli, M.D.
        • Contact:
          • Sandra Prentiss, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Potential participants for the study are patients who have been diagnosed with severe to profound hearing loss (HL) and plan to undergo cochlear implantation (CI) at the University of Miami. The cochlear implant surgery, pre and post-surgical care, and activation and programming of the implant are part of the participants' standard of care. If the inclusion criteria are met (age 18 years and older, equal number of men and women, profound sensorineural hearing loss (for safety study n=6) and residual hearing (see criteria below) from pre-surgical auditory brainstem response (ABR) (for efficacy study n=48), equal numbers of CI devices from all 3 manufactures and English or Spanish speakers the patient will be approached by the study personnel and will be asked to participate in the study.

Exclusion Criteria:

Subjects under 18 years of age. Subjects not meeting functional hearing requirements.

Types of CI devices:

The study will enroll patients receiving CI devices from all three manufactures.

  1. Advanced Bionics (FDA indications - severe to profound sensorineural hearing loss (greater than or equal to 70 dB HL)

    1. HiRes Ultra 3D slim J
    2. HiRes Ultra 3D midScala

  2. Cochlear Corporation (FDA indications - moderate to profound sensorineural hearing loss; sentence recognition less than or equal to 50% in the ear to be implanted AND less than or equal to 60% in the contralateral ear

    1. CI632
    2. CI622
    3. CI612

  3. Med-EL (moderately-severe to severe sensorineural hearing loss (greater than or equal to 65 db HL).

    1. Synchrony 2 Flex soft
    2. Synchrony 2 Flex28
    3. Synchrony 2 Flex 24
    4. Synchrony 2 Compressed
    5. Synchrony 2 Medium

Additional patients receiving devices not listed here may be eligible as the criteria by manufacturer change.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Safety Study
Aim 1: Ascertain the safety of the system and device in patients undergoing cochlear implantation (CI). Mild therapeutic hypothermia will be delivered to the subjects during CI surgery via the ear canal.
Device: Intra-Ear Canal Cooling Catheter
Mild therapeutic hypothermia will be applied via the catheter device installed inside the ear canal by an experienced surgeon during cochlear implantation (CI) surgery.
Experimental: Efficacy Study Cooling
Aim 2: Ascertain the applicability and efficacy of the device and system in patients undergoing cochlear implantation (CI). Half of the candidates will receive mild therapeutic hypothermia via the ear canal during cochlear implant surgery.
Device: Intra-Ear Canal Cooling Catheter
Mild therapeutic hypothermia will be applied via the catheter device installed inside the ear canal by an experienced surgeon during cochlear implantation (CI) surgery.
No Intervention: Efficacy Study Control
Aim 2: Ascertain the applicability and efficacy of the device and system in patients undergoing cochlear implantation (CI). Half of the candidates will receive standard of care (no cooling) during cochlear implant surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pure Tone Audiometry
Time Frame: At initial cochlear implant activation or 1 month post-operatively; 3 and 12 months post-operatively
Pure-tone average (PTA) of 125, 250 and 500 Hz which will be tested post-operatively in the safety and efficacy arms to measure residual hearing. A clinically significant change in hearing is greater than 10 dB HL (decibels hearing level) shift.
At initial cochlear implant activation or 1 month post-operatively; 3 and 12 months post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrophysiological Impedance
Time Frame: Immediately post-operatively/during surgery; at initial cochlear implant activation/1 month post-operatively; 3 and 12 months post-operatively
Per standard of care, electrophysiological impedances will be compared between groups intra- and post-operatively to measure CI device and electrode function. Impedances will be measured in the safety and efficacy arms.
Immediately post-operatively/during surgery; at initial cochlear implant activation/1 month post-operatively; 3 and 12 months post-operatively
Electrically Evoked Compound Action Potential (ECAP)
Time Frame: Immediately post-operatively/during surgery; at initial cochlear implant activation/1 month post-operatively
Per standard of care, ECAP will be compared between groups intra- and post-operatively to test CI device function. ECAP will be measured in the safety and efficacy arms.
Immediately post-operatively/during surgery; at initial cochlear implant activation/1 month post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Restorear Devices LLC

Collaborators

University of Miami
National Institute on Deafness and Other Communication Disorders (NIDCD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC019586
  • 5R44DC019586 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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.

No

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.

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