Therapeutic Hypothermia for Hearing Preservation During Cochlear Implants

Overseen By Curtis S King

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Restorear Devices LLC

Disqualifiers: Under 18, Not meeting hearing requirements

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mild therapeutic hypothermia (cooling therapy) during cochlear implant surgery can preserve any remaining hearing. The researchers aim to determine if this cooling method is safe and effective. Participants will either receive cooling therapy using the Intra-Ear Canal Cooling Catheter during surgery or join a control group without it. The study seeks individuals with severe to profound hearing loss who plan to receive a cochlear implant at the University of Miami. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance hearing preservation techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this therapeutic hypothermia technique is safe for cochlear implant surgery?

Research has shown that cooling the ear during cochlear implant surgery is safe for patients. This method, known as mild therapeutic hypothermia, helps protect any remaining hearing. Studies have demonstrated that standard surgical techniques can safely achieve this cooling. The process effectively lowers the temperature in the inner ear to potentially beneficial levels. While these results are encouraging, participating in a clinical trial can help confirm these findings and ensure the technique's safety for more people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard procedures for cochlear implants, which typically focus solely on the surgical placement of the device, the treatment being studied introduces a cooling catheter to deliver mild therapeutic hypothermia directly to the ear canal during surgery. This innovative approach aims to preserve hearing by reducing inflammation and protecting delicate inner ear structures. Researchers are excited about this technique because it could enhance the outcomes of cochlear implants by minimizing hearing loss during the procedure, offering a potentially significant improvement over existing methods.

What evidence suggests that the Intra-Ear Canal Cooling Catheter is effective for preserving hearing during cochlear implant surgery?

This trial will evaluate the use of therapeutic hypothermia during cochlear implant surgery. Research has shown that gently cooling the ear during surgery can help protect remaining hearing. In this trial, some participants will receive mild therapeutic hypothermia via the Intra-Ear Canal Cooling Catheter, which previous studies have safely tested. Early results indicate that cooling the inner ear can be done safely and might help preserve hearing during surgery. Meanwhile, other participants will receive standard care without cooling. Overall, these findings are promising for using cooling to maintain hearing ability after cochlear implant procedures. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing cochlear implant surgery who are interested in trying a new method to preserve their remaining hearing. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely participating.

Inclusion Criteria

Residual hearing from pre-surgical ABR

Equal numbers of CI devices from all 3 manufacturers

Patients planning to undergo cochlear implantation at the University of Miami

Exclusion Criteria

I am under 18 years old.

Subjects not meeting functional hearing requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo cochlear implant surgery with mild therapeutic hypothermia delivered via the ear canal

1 day

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and effectiveness immediately post-operatively and at initial cochlear implant activation

1 month

2 visits (in-person)

Extended Follow-up

Participants are monitored for long-term safety and effectiveness of the treatment

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Intra-Ear Canal Cooling Catheter

Trial Overview The study is testing the safety and effectiveness of using mild therapeutic hypothermia during cochlear implant surgery. It involves comparing outcomes between patients receiving this cooling therapy and those who do not (control group).

How Is the Trial Designed?

Group I: Safety Study Experimental Treatment 1 Intervention

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 II: Efficacy Study Cooling Experimental Treatment 1 Intervention

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 III: Efficacy Study Control Active Control 1 Intervention

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.

Intra-Ear Canal Cooling Catheter is already approved in United States for the following indications:

Approved in United States as Intra-Ear Canal Cooling Catheter for:

• Preservation of residual hearing in cochlear implant surgery

Who Is Running the Clinical Trial?

Restorear Devices LLC

Lead Sponsor

Trials

2

Recruited

170+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Published Research Related to This Trial

Mild therapeutic hypothermia (MTH) in the cochlea can be effectively achieved through ear canal cooling, with cool water (30°C) reaching MTH in about 4 minutes and ice-chilled water in approximately 2 minutes.

Using a Peltier device with a longer earmold improves cooling efficiency, allowing MTH to be reached in about 16 minutes, demonstrating the importance of earmold design in achieving effective cochlear temperature changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving Mild Therapeutic Hypothermia in the Human Cochlea. Arteaga, AA., Beatrous, B., Eby, TL., et al.[2023]

Localized therapeutic hypothermia can effectively lower cochlear temperature by 4 to 6 °C within 16 to 18 minutes, which may help protect residual hearing during cochlear implantation surgery.

The study demonstrated a strong correlation between experimental results and computer model predictions, indicating that the custom-designed hypothermia delivery system could be a promising method to preserve hearing function in patients undergoing cochlear implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theoretical Evaluation and Experimental Validation of Localized Therapeutic Hypothermia Application to Preserve Residual Hearing After Cochlear Implantation. Tamames, I., King, C., Huang, CY., et al.[2019]

Using standard surgical rinsing techniques during cochlea implantation can effectively induce therapeutic hypothermia, which helps protect against damage and preserve hearing.

Iced water rinsing resulted in the most significant temperature drops in the cochlea, demonstrating that this method can be easily implemented in clinical settings to enhance hearing preservation during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of the Intracochlear Hypothermia Distribution Utilizing Tympanic Cavity Hypothermic Rinsing Technique in a Cochlea Hypothermia Model. Bader, W., Gottfried, T., Degenhart, G., et al.[2021]

Mild to moderate therapeutic hypothermia (4 to 6 °C) applied to the cochlea during cochlear implant surgery significantly reduces residual hearing loss caused by electrode insertion trauma, as demonstrated in a study with rats.

Histological analysis confirmed that hypothermia treatment preserved outer hair cells compared to normothermic conditions, indicating a protective effect against trauma during implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cool approach to reducing electrode-induced trauma: Localized therapeutic hypothermia conserves residual hearing in cochlear implantation. Tamames, I., King, C., Bas, E., et al.[2021]

Localized, mild therapeutic hypothermia can be effectively applied during cochlear implantation surgery without compromising the visibility of critical structures, as shown in a study using ten human cadaveric temporal bones.

The study demonstrated that both the facial recess and myringotomy approaches successfully reduced temperatures at the round window by approximately 4.57°C and 4.11°C, respectively, suggesting a feasible method for preserving residual hearing during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomical Correlates and Surgical Considerations for Localized Therapeutic Hypothermia Application in Cochlear Implantation Surgery. Perez, E., Viziano, A., Al-Zaghal, Z., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-hypothermia-5-2024-5a49a

Therapeutic Hypothermia for Hearing Preservation During ... Research suggests that using therapeutic hypothermia during cochlear implant surgery is feasible and can be safely achieved with standard surgical irrigation ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5999525/

Theoretical evaluation and experimental validation of ... This study provides insight for design, operation and protocols for efficacious delivery of mild therapeutic hypothermia to the human cochlea.

3. ctv.veeva.com ctv.veeva.com/study/investigation-of-a-device-to-deliver-intra-operative-therapeutic-hypothermia-for-hearing-preservatio

Investigation of a Device to Deliver Intra-Operative ... This clinical trial will evaluate a novel mild therapeutic hypothermia device as an effective therapy to preserve residual hearing post-CI. This ...

4. journals.lww.com journals.lww.com/otology-neurotology/fulltext/9900/development_and_evaluation_of_a_novel_transcanal.878.aspx

Development and Evaluation of a ... In conclusion, these findings demonstrate that cochlear and vestibular hypothermia can be effectively induced using an external cooling system positioned in the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5018430/

A cool approach to reducing electrode-induced trauma Collectively, these results suggest that therapeutic hypothermia during cochlear implantation may reduce traumatic effects of electrode insertion and improve ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06375278/investigation-of-a-device-to-deliver-intra-operative-therapeutic-hypothermia-for-hearing-preservation-in-cochlear-implantation?mp=BCF&page=4&id=847&slug=hearing-impairment

Investigation of a Device to Deliver Intra-Operative ... The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12064389/

Numerical Simulations and Experimental Measurements in ... This study demonstrates that localized, noninvasive MTH can effectively reduce inner ear temperatures to therapeutically relevant levels.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6750193/

Anatomical Correlates and Surgical Considerations for ... Application of localized, mild therapeutic hypothermia during cochlear implantation (CI) surgery is feasible for residual hearing preservation.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0378595516300880

A cool approach to reducing electrode-induced trauma ... Collectively, these results suggest that therapeutic hypothermia during cochlear implantation may reduce traumatic effects of electrode insertion and improve ...