Therapeutic Hypothermia for Noise-Induced Hearing Loss

Overseen By Curtis S King

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Restorear Devices LLC

Disqualifiers: Abnormal tympanometry, Otologic pathologies, Tinnitus treatment, others

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

Compensation: Varies

Number of Visits: 8

116 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for preservation of sensory structures in the cochlea after noise exposure. The main aims of the study are: 1. To test the safety and best duration for use for a new hypothermia device. 2. To determine if the hypothermia device helps decrease noise-induced hearing loss in a group of firefighters. Participants will wear the mild therapeutic hypothermia therapy devices immediately after a fire service shift serially over a year. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy and a sham therapy).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are currently receiving treatment for tinnitus or other ear conditions, you may not be eligible to participate.

What data supports the effectiveness of the treatment Cold pack-delivered mild therapeutic hypothermia for Noise-Induced Hearing Loss?

Research shows that mild therapeutic hypothermia (cooling the body slightly) has been used to improve outcomes in patients with traumatic brain injuries and after cardiac arrest. This suggests that cooling might help reduce damage in other conditions, like noise-induced hearing loss, by protecting cells from further injury. ^{1 2 3 4 5}

How is the treatment Cold pack-delivered mild therapeutic hypothermia unique for noise-induced hearing loss?

Cold pack-delivered mild therapeutic hypothermia is unique because it uses cooling to protect hearing by slowing down metabolic processes and reducing oxidative stress, which are different mechanisms compared to other treatments that might focus on drugs or surgery. ^{6 7 8 9 10}

Research Team

Suhrud M Rajguru, PhD

Principal Investigator

RestorEar Devices

Eligibility Criteria

This trial is for firefighters who have been exposed to loud noise during their shifts and are at risk for noise-induced hearing loss. Participants should be willing to wear a hypothermia therapy device after their shifts over a year. Specific eligibility details are not provided, but typically, participants must meet certain health criteria and not have conditions that would exclude them from safely participating.

Inclusion Criteria

* Fluency in English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Evaluation

Non-firefighter control subjects receive MTH-treatment and normothermia-sham through the device alternated over 8 sessions. Subjective assessments and audiologic testing pre- and post-treatments will be compared.

4 weeks

8 visits (in-person)

Efficacy Evaluation

Firefighters and control groups receive MTH-treatment or sham treatment quarterly. Baseline hearing function is measured prior to initiation, and treatments are repeated quarterly over one year.

52 weeks

Quarterly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including weekly remote surveys to evaluate device use and noise exposure.

4 weeks

Treatment Details

Interventions

• Cold pack-delivered mild therapeutic hypothermia

Trial Overview The study is testing a non-invasive hypothermia device applied using a cold pack to see if it can protect against hearing loss after noise exposure. Firefighters will use the device after their shifts, and their hearing will be compared to those who didn't receive the therapy or received a sham (fake) therapy.

Participant Groups

Group I: Safety Arm Experimental Treatment 1 Intervention

Non-firefighter control subjects will receive MTH-treatment and normothermia-sham through the device alternated over 8 sessions. Subjective assessments and audiologic testing pre- and post-treatments will be compared between MTH-treatment and sham in each subject. n=24.

Group II: Efficacy Arm 1 - Treatment Experimental Treatment 1 Intervention

Firefighters will receive hypothermia treatment delivered with ReBound devices, applied post-work shift. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and functional assessments will be repeated quarterly over one year. Temporary and permanent threshold changes in this chronically noise exposed group of firefighters receiving MTH-treatment will be compared with firefighters receiving sham-treatment and with controls receiving MTH-treatment. Subjects in this group will also be sent home with a device to use after noise exposure during the study period. They will complete weekly, remote surveys collecting data on their noise exposure and device use. n=24.

Group III: Efficacy Arm 2 - Non-Therapeutic Active Control 1 Intervention

Firefighters will receive non-therapeutic "treatment" delivered with normothermic ReBound devices, applied post-work shift. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and functional assessments will be repeated quarterly over one year. n=24.

Group IV: Efficacy Arm 3 - Control Active Control 1 Intervention

Age- and sex-matched non-firefighter control group will receive MTH-treatment quarterly over the same duration. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and functional assessments will be repeated quarterly over one year. Subjects in this group will also be sent home with a device to use after noise exposure during the study period. They will complete weekly, remote surveys collecting data on their noise exposure and device use. n=24.

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

Hypothermia has shown protective effects on the brain after traumatic brain injury (TBI) in animal studies, but clinical results have been inconsistent, possibly due to the complex nature of injuries in humans.

This review highlights the need for more sophisticated experimental models that include secondary injuries like hypotension and hypoxemia to better understand the efficacy of hypothermia in TBI treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary injuries in brain trauma: effects of hypothermia. Fritz, HG., Bauer, R.[2019]

In a post hoc analysis of the B-HYPO study involving 97 patients with severe traumatic brain injury (TBI), slow rewarming after mild therapeutic hypothermia (MTH) for more than 48 hours was associated with significantly better neurological outcomes in patients with evacuated hematomas, with a 65% good outcome rate compared to 22% for those rewarmed in 48 hours or less.

The study suggests that the method of rewarming may play a critical role in the effectiveness of MTH for improving neurological recovery in TBI patients, highlighting the need for further research to establish optimal rewarming protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slow rewarming improved the neurological outcomes of prolonged mild therapeutic hypothermia in patients with severe traumatic brain injury and an evacuated hematoma. Kaneko, T., Fujita, M., Yamashita, S., et al.[2019]

The titration method of mild hypothermia therapy was found to be clinically feasible for reducing intracranial pressure in nine severely head-injured patients, with a significant decrease in mean intracranial pressure from 24 to 15 mm Hg after treatment.

Despite the effectiveness in lowering intracranial pressure, the method was associated with systemic complications, including infections and changes in blood markers, indicating a need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the titration method of mild hypothermia in severely head-injured patients with intracranial hypertension. Tateishi, A., Soejima, Y., Taira, Y., et al.[2019]

In a study of 90 out-of-hospital cardiac arrest survivors treated with mild therapeutic hypothermia, older age and lower Glasgow Coma Scale scores were linked to poorer neurological outcomes, with 61% of survivors achieving good outcomes at discharge.

Factors predicting in-hospital mortality included older age, lower GCS scores, the presence of cardiogenic shock, and higher doses of adrenaline, while shorter CPR duration and lower lactate levels were associated with longer induction times for mild therapeutic hypothermia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mild therapeutic hypothermia after out-of-hospital cardiac arrest: What does really matter? Ratajczak, J., Łach, P., Umińska, JM., et al.[2021]

Pre-hospital mild therapeutic hypothermia (MTH) significantly lowers intracranial pressure (ICP) in patients with severe traumatic brain injury (sTBI) compared to those who receive MTH after hospital admission, with lower ICP values observed at 24, 48, and 72 hours post-treatment.

Patients receiving pre-hospital MTH also had a higher rate of favorable neurological outcomes, as measured by the Glasgow Outcome Scale, with 65.1% achieving scores of 4-5, compared to only 37.2% in the late MTH group, and this was achieved without complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-hospital mild therapeutic hypothermia for patients with severe traumatic brain injury. Qiu, W., Chen, M., Wang, X., et al.[2022]

In a multicenter pilot trial involving 172 patients with idiopathic sudden sensorineural hearing loss (ISSHL), the addition of local hypothermia using a cooled water pillow significantly improved hearing recovery rates compared to standard medication alone.

The hypothermic treatment, combined with restricted activity, was particularly effective in younger patients, suggesting that mild hypothermia may enhance the efficacy of conventional treatments for hearing restoration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local hypothermia in the treatment of idiopathic sudden sensorineural hearing loss. Hato, N., Hyodo, J., Takeda, S., et al.[2013]

Mild therapeutic hypothermia (TH) has emerged as a promising strategy for protecting against acquired hearing loss, potentially targeting multiple mechanisms such as reduced oxidative stress and slowed metabolism.

While systemic antioxidant therapies have limitations, particularly with certain ototoxic drugs like cisplatin, further research is needed to fully understand how mild TH can be effectively applied to different types of hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mild Therapeutic Hypothermia and Putative Mechanisms of Hair Cell Survival in the Cochlea. Spankovich, C., Walters, BJ.[2023]

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 therapeutic hypothermia (MTH) effectively preserved residual hearing for up to 3 months after cochlear implant surgery in a rodent model, demonstrating its potential as a protective measure against surgical trauma.

The study found that MTH was safe for local application during surgery and activated beneficial gene expression pathways related to inflammation and immune responses, which may help mitigate damage from electrode insertion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mild therapeutic hypothermia protects against inflammatory and proapoptotic processes in the rat model of cochlear implant trauma. Sangaletti, R., Tamames, I., Yahn, SL., et al.[2023]

In a study of 51 infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy, 5 cases of transient respiratory stridor were observed, indicating a potential adverse effect of the treatment.

The occurrence of stridor was noted at various stages of the cooling process and was not linked to intubation, suggesting the need for further investigation through laryngoscopy to understand the underlying causes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stridor in asphyxiated neonates undergoing therapeutic hypothermia. Orme, J., Kissack, C., Becher, JC.[2014]

References

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

Secondary injuries in brain trauma: effects of hypothermia. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Slow rewarming improved the neurological outcomes of prolonged mild therapeutic hypothermia in patients with severe traumatic brain injury and an evacuated hematoma. [2019]

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

Feasibility of the titration method of mild hypothermia in severely head-injured patients with intracranial hypertension. [2019]

4. Poland pubmed.ncbi.nlm.nih.gov

Mild therapeutic hypothermia after out-of-hospital cardiac arrest: What does really matter? [2021]

5. England pubmed.ncbi.nlm.nih.gov

Pre-hospital mild therapeutic hypothermia for patients with severe traumatic brain injury. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Local hypothermia in the treatment of idiopathic sudden sensorineural hearing loss. [2013]

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

Mild Therapeutic Hypothermia and Putative Mechanisms of Hair Cell Survival in the Cochlea. [2023]

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

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

9. Netherlands pubmed.ncbi.nlm.nih.gov

Mild therapeutic hypothermia protects against inflammatory and proapoptotic processes in the rat model of cochlear implant trauma. [2023]

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

Stridor in asphyxiated neonates undergoing therapeutic hypothermia. [2014]