Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
NCT ID: NCT06375278
Last Updated: 2024-11-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
54 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-09-23
Study Completion Date
2026-07-31
Brief Summary
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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).
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).
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Detailed Description
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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.
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.
Conditions
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Cochlear Implants
Cochlear Implantation
Hearing Loss
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
For the safety study (aim 1), a single group (n=6) will receive the cooling treatment. For the efficacy study (aim 2) patients will be randomized to either a treatment or control arm in a 1:1 ratio (n=24 per group) in a parallel model.
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
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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.
Group Type
EXPERIMENTAL
Intra-Ear Canal Cooling Catheter
Intervention Type
DEVICE
Mild therapeutic hypothermia will be applied via the catheter device installed inside the ear canal by an experienced surgeon during cochlear implantation (CI) surgery.
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.
Group Type
EXPERIMENTAL
Intra-Ear Canal Cooling Catheter
Intervention Type
DEVICE
Mild therapeutic hypothermia will be applied via the catheter device installed inside the ear canal by an experienced surgeon during cochlear implantation (CI) surgery.
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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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.
Intervention Type
DEVICE
Eligibility Criteria
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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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Miami
OTHER
Sponsor Role
collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
Sponsor Role
collaborator
Restorear Devices LLC
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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University of Miami
Miami, Florida, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Suhrud M Rajguru, Ph.D.
Role: backup
Michael Hoffer, M.D.
Role: backup
Fred Telischi, M.D.
Role: backup
Simon Angeli, M.D.
Role: backup
Sandra Prentiss, Ph.D.
Role: backup
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DC019586
Identifier Type: -
Identifier Source: org_study_id
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