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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06375278
• Other study ID #: DC019586
• Secondary ID: 5R44DC019586
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: Restorear Devices LLC
• Contact: Suhrud M Rajguru, Ph.D.
• Phone: 801-641-8180
• Email: srajguru[@]restorear.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Potential participants for the study are patients who have been diagnosed with severe to profound hearing loss and plan to undergo cochlear implantation 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 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.

Related Conditions & MeSH terms

• Cochlear Implantation
• Cochlear Implants
• Hearing Loss
• Hypothermia

Intervention

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.
• Intra-Ear Canal Cooling Catheter (Sham)
Sham version of the device will be placed by an experienced surgeon inside the ear canal during cochlear implantation (CI) surgery.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Restorear Devices LLC	National Institute on Deafness and Other Communication Disorders (NIDCD), University of Miami

Country where clinical trial is conducted

United States, 

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* Note: There are 111 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cochlear Implant (CI) Device Performance Following Hypothermia Treatment	In standard of care, device (CI) performance at the time of cochlear implant activation will be observed and measured with impedance.	3 months
Primary	Residual Hearing	Pure-tone average (PTA) of 125, 250 and 500 Hz which will be tested post-operatively, a clinically significant change in hearing is greater than 10 dB HL (decibels hearing level) shift.	1, 3 and 6 months post-operatively
Secondary	Electrophysiological Impedance	In standard of care, electrophysiological impedance will be compared between groups intra- and post-operatively to measure CI device and electrode function.	1, 3 and 6 months post-operatively
Secondary	Electrically Evoked Compound Action Potential (ECAP)	In standard of care, ECAP will be compared between groups intra- and post-operatively to test CI device function.	1, 3 and 6 months post-operatively