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

Trial Summary

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 data supports the effectiveness of the treatment Intra-Ear Canal Cooling Catheter, Intra-Ear Canal Cooling Catheter, Therapeutic Hypothermia Device, ReSurg for hearing preservation during cochlear implants?

Research shows that applying mild therapeutic hypothermia (cooling) during cochlear implant surgery can help protect the inner ear and preserve hearing by reducing damage and inflammation. Studies have demonstrated that cooling the ear can effectively lower temperatures in the cochlea, which helps protect the delicate hair cells and maintain residual hearing. ^{1 2 3 4 5}

Is therapeutic hypothermia safe for use in humans during cochlear implant surgery?

Research suggests that using therapeutic hypothermia during cochlear implant surgery is feasible and can be safely achieved with standard surgical irrigation fluids. This cooling method has been shown to protect the inner ear without causing harm. ^{1 2 3 4 5}

How does the Intra-Ear Canal Cooling Catheter treatment differ from other treatments for hearing preservation during cochlear implants?

The Intra-Ear Canal Cooling Catheter treatment is unique because it uses localized therapeutic hypothermia (cooling) to protect the inner ear during cochlear implant surgery, which helps preserve residual hearing. This approach is different from other treatments as it directly cools the ear canal to reduce trauma and inflammation, which are common causes of hearing loss after surgery. ^{1 2 3 4 5}

What is the purpose of this trial?

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).

Eligibility Criteria

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

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)

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Anatomical Correlates and Surgical Considerations for Localized Therapeutic Hypothermia Application in Cochlear Implantation Surgery. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Theoretical Evaluation and Experimental Validation of Localized Therapeutic Hypothermia Application to Preserve Residual Hearing After Cochlear Implantation. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Measurement of the Intracochlear Hypothermia Distribution Utilizing Tympanic Cavity Hypothermic Rinsing Technique in a Cochlea Hypothermia Model. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Achieving Mild Therapeutic Hypothermia in the Human Cochlea. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A cool approach to reducing electrode-induced trauma: Localized therapeutic hypothermia conserves residual hearing in cochlear implantation. [2021]