Therapeutic Hypothermia for Tinnitus

Overseen By Kendall Stern, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Restorear Devices LLC

Disqualifiers: Vertigo, Menière's, Otitis, Raynaud's, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if mild therapeutic hypothermia (cooling therapy) can reduce the symptoms of chronic tinnitus, a condition characterized by hearing ringing or buzzing without an external source. Participants will use a cooling device for 30 minutes, and researchers will compare their experiences to those using a non-cooling device. Individuals with constant tinnitus for at least 30 days who are not currently receiving other treatments might be suitable for this study. The trial also evaluates the comfort and acceptability of the cooling device for users. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new treatment options for tinnitus.

Will I have to stop taking my current medications?

The trial requires that participants are not currently receiving any medical, pharmacologic, or therapeutic intervention for tinnitus or other ear-related conditions. If you are on such treatments, you would need to stop them to participate.

What prior data suggests that this hypothermia device is safe for tinnitus patients?

Research has shown that mild therapeutic hypothermia, a controlled cooling treatment, is generally safe and well-tolerated. Studies have demonstrated that this method can be safely applied to the inner ear. In past research, participants reported no major negative effects from this cooling treatment, experiencing only minor side effects. This makes it a comfortable choice for many. While researchers continue to study its use in tinnitus, the evidence so far suggests it is a safe option with manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for tinnitus, which often involve sound therapy or medications aimed at masking or managing symptoms, therapeutic hypothermia offers a unique approach. This method involves applying mild cold through a headband-style device, potentially providing relief by cooling specific areas related to tinnitus perception. Researchers are excited because this non-invasive technique could offer a new way to alleviate symptoms without the need for drugs or extensive therapy sessions, making it a promising option for patients seeking alternative treatments.

What evidence suggests that mild therapeutic hypothermia is effective for tinnitus?

Research has shown that mild therapeutic hypothermia (MTH) might reduce tinnitus symptoms. This method cools the inner ear to slow its activity, potentially protecting hearing. Some studies have examined MTH for hearing loss from loud noise, suggesting it might preserve hearing functions. While these results are promising, they primarily highlight the potential benefits of cooling therapies. In this trial, participants in the experimental arm will receive MTH through a headband-style device. More research is needed to confirm MTH's effectiveness for long-term tinnitus. ^{1 2 4 6 7}

Who Is on the Research Team?

Suhrud Rajguru, PhD

Principal Investigator

RestorEar Devices

Kendall Stern, MPH

Principal Investigator

RestorEar Devices

Are You a Good Fit for This Trial?

This trial is for individuals with chronic tinnitus, which means they experience persistent ringing in their ears. Participants will be asked to use a hypothermia therapy device for a single session and complete questionnaires about their tinnitus severity.

Inclusion Criteria

I am between 18 and 55 years old and have tinnitus.

I have been experiencing ringing in my ears for over a month.

My tinnitus is severe, with a THI score of 12 or more.

Exclusion Criteria

I have a history of ear or balance issues due to specific conditions.

Individuals with a history of extreme sensitivity to cold or heat, including individuals with a past history of frostbite or Raynaud's Syndrome

I experience a pulsing sound in my ears that's not caused by external noise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants wear the mild therapeutic hypothermia therapy devices for a single 30-minute session

1 day

1 session (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Cold pack-delivered mild therapeutic hypothermia

Trial Overview The study is testing the effectiveness of cold pack-delivered mild therapeutic hypothermia (MTH) against no treatment (sham) in reducing symptoms of chronic tinnitus. The comfort and acceptability of the device are also being evaluated.

How Is the Trial Designed?

Group I: Experimental Arm Experimental Treatment 1 Intervention

Participants will wear a headband-style device for 30 minutes in a single session. Subjective assessments will be completed via Qualtrics XM, and responses will be compared to those in the Sham Arm. n=40

Group II: Control Arm Placebo Group 1 Intervention

Participants will wear a headband-style control device for a single 30 minute session. Subjective assessments will be completed via Qualtrics XM, and responses will be compared to those in the Experimental Arm. n=40

Who Is Running the Clinical Trial?

Restorear Devices LLC

Lead Sponsor

Trials

2

Recruited

170+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07071480

NCT07071480 | Noninvasive Therapy for Tinnitus The goal of this interventional clinical study is to establish mild therapeutic hypothermia, delivered non-invasively to the structures of the inner ear, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07017998

NCT07017998 | External Therapy for Tinnitus Management Mild therapeutic hypothermia (cooling), delivered non-invasively to the structures of the inner ear (cochlea) for 30 minutes, using headband-style proprietary ...

3. patlynk.com patlynk.com/trial/NCT07017998

Mild Therapeutic Hypothermia Device for Chronic Tinnitus This study is exploring a new approach using mild therapeutic hypothermia (MTH) to potentially reduce the severity of tinnitus symptoms.

4. withpower.com withpower.com/trial/phase-deafness-11-2024-f12f1

Therapeutic Hypothermia 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 ...

5. ctv.veeva.com ctv.veeva.com/study/non-invasive-system-to-deliver-therapeutic-hypothermia-for-protection-against-noise-induced-hearing

Non-Invasive System to Deliver Therapeutic Hypothermia for ... The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for preservation of sensory ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10826421/

Targeted therapeutic hypothermia protects against noise ... Our results show that mild hypothermia can be applied quickly and safely to the inner ear following noise exposure. We show that localized ...

7. withpower.com withpower.com/trial/phase-tinnitus-6-2025-dc259

Therapeutic Hypothermia for Tinnitus · Info for Participants ... Cold pack-delivered mild therapeutic hypothermia will have tolerable side effects & efficacy for patients with Tinnitus, Tinnitus and Ringing in the Ears ...