Therapeutic Hypothermia for Tinnitus

Overseen By Suhrud M Rajguru, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Restorear Devices LLC

Disqualifiers: Severe anxiety, Catastrophic tinnitus, Otologic pathologies, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for chronic tinnitus, a persistent ringing in the ears. Researchers aim to determine if a special cooling device, the ReBound hypothermia device, can safely reduce tinnitus symptoms. This device delivers mild therapeutic hypothermia through cold packs. Participants will use the device for 30 minutes in a clinic and then at home for six months, comparing their results to those using a non-active version of the device. Ideal candidates are adults who experience ringing in their ears most of the day and are not currently using other treatments. As an unphased trial, this study offers patients the chance 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 excludes those who are currently receiving medical, pharmacologic, or therapeutic intervention for tinnitus or other ear-related conditions, so you may need to stop such treatments to participate.

What prior data suggests that this method is safe for tinnitus treatment?

Research has shown that using a cold pack on the ear, known as mild therapeutic cooling, is generally easy to handle. In studies with the ReBound device, side effects were minor and manageable. Participants experienced only mild discomfort, indicating that this cooling treatment is safe for home use. No serious negative effects were linked to the device. This is encouraging for those considering this therapy for tinnitus relief. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about therapeutic hypothermia for tinnitus because it offers a novel approach compared to traditional methods like sound therapy and medication. This treatment uses cold pack-delivered mild therapeutic hypothermia, which is designed to reduce the perception of tinnitus by potentially altering nerve activity in the auditory pathways. Unlike other treatments that often require ongoing sessions or daily medication intake, this method involves a single in-clinic session followed by at-home use of a device as needed for six months. This innovative approach could offer a non-invasive, convenient alternative that provides relief with fewer treatment sessions.

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

This trial will compare the effects of mild therapeutic hypothermia with a sham device for tinnitus. Research has shown that gently cooling the inner ear might alleviate tinnitus symptoms. One study found that cooling the ear for 30 minutes could reduce tinnitus by slowing certain processes in the ear. This cooling method has been previously examined for hearing protection, suggesting potential benefits. Early results indicate that this treatment could ease tinnitus by reducing ear activity that may cause it. While more research is needed, this technique appears promising for individuals with chronic tinnitus. ^{1 2 3 5 6}

Who Is on the Research Team?

Suhrud M Rajguru, PhD

Principal Investigator

RestorEar Devices

Are You a Good Fit for This Trial?

Adults over 18 with chronic tinnitus, hearing a ringing in their ears for most of the day. They must understand English or Spanish and have at least mild tinnitus based on THI scores. Excluded are those with severe anxiety, abnormal ear function tests, active hearing aid use, pregnant women, prisoners, certain types of tinnitus (non-auditory/pulsatile), catastrophic levels of tinnitus, intermittent nature of tinnitus, specific ear diseases or conditions affecting the jaw.

Inclusion Criteria

I am 18 years old or older.

I am fluent in English or Spanish.

I have been hearing ringing in my ears for most of the day for over a month.

Exclusion Criteria

Severe anxiety, score ≥ 15 on the Generalized Anxiety Disorder-7 (GAD-7)

Abnormal tympanometric findings

Presence of conductive component as characterized by air-bone gaps ≥15 dB at two or more consecutive frequencies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive a single 30-minute session of mild therapeutic hypothermia using the ReBound device in-clinic. Baseline audiometric testing and subjective tinnitus assessment are conducted before and immediately after treatment.

1 day

1 visit (in-person)

In-home Treatment

Participants use the ReBound device at home as needed for 6 months and complete monthly online surveys to monitor tinnitus severity and potential adverse events.

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment through monthly surveys and assessments.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cold pack-delivered mild therapeutic hypothermia
• Sham device

Trial Overview The study is testing a noninvasive device called ReBound that delivers mild therapeutic hypothermia to the inner ear to relieve symptoms of chronic tinnitus. Participants will compare using this device against a sham therapy over six months through home usage and online symptom surveys.

How Is the Trial Designed?

Group I: Mild Therapeutic Hypothermia (MTH) Arm Experimental Treatment 1 Intervention

Subjects will receive hypothermia treatment delivered with ReBound devices, applied in a single 30 minute session in-clinic. Baseline audiometric testing and subjective tinnitus assessment will be measured prior to initiation of the treatment. Testing will be repeated immediately after treatment, and changes will be noted. Subjects in this group will also be sent home with a device to use as needed for a period of 6 months. They will be asked to complete monthly subjective surveys online assessing tinnitus severity and monitoring potential adverse events. MTH Arm will complete both Aims 1 and 2. n=20.

Group II: Control Arm Placebo Group 1 Intervention

Subjects will receive a sham wearable headband in a single 30 minute session in-clinic. Baseline audiometric testing and subjective tinnitus assessment will be measured prior to initiation of the treatment. Testing will be repeated immediately after treatment, and changes will be noted. Subjects in this group will also be sent home with a device to use as needed for a period of 6 months. They will be asked to complete monthly subjective surveys online assessing tinnitus severity and monitoring potential adverse events. Control Arm will complete both Aims 1 and 2. n=20.

Who Is Running the Clinical Trial?

Restorear Devices LLC

Lead Sponsor

Trials

2

Recruited

170+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

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. 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 ...