Clinical trial NCT07017998: External Therapy for Tinnitus Management
Official title: Mild Therapeutic Hypothermia for Tinnitus Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus
Tinnitus, Subjective
Keywords: tinnitus
ringing in the ears
ringing ears
symptom management
cooling
red light therapy
Lead sponsor: Restorear Devices LLC
Sponsor class: INDUSTRY
First posted: 2025-06-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a prospective, single-blind and decentralized randomized control study. All study procedures and data collection will be completed by participants remotely using online modules under the guidance of an audiologist.

Participants will be sent a test kit to complete the study procedures on their own time and will access an online module for data collection via Qualtrics XM. Participants will be asked to use a wearable, headband-style device with removable cold packs, frozen in a conventional household freezer, and to respond to questions about their tinnitus experience. Participants will be told that the study title is "Consumer Tinnitus External Therapy Study" to maintain blinding to the therapy for the sham/control
Primary purpose: TREATMENT

Brief summary: The goal of this remote interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for the symptomatic relief of chronic tinnitus. The main aims of the study are:

1. Ascertain the effects of MTH in chronic tinnitus patients using questionnaires measuring tinnitus severity and intervention-related change.
2. Ascertain the comfort and acceptability of the hypothermia device and therapy.

Participants with chronic tinnitus will wear the mild therapeutic hypothermia therapy devices for a single 30 minute session. Researchers will compare results from those receiving the therapy to those from a sham group (individuals receiving a sham therapy).

Detailed description: Tinnitus is the perception of sound in the absence of an external stimulus, commonly described as ringing in the ears. Tinnitus is a highly common condition, with most individuals experiencing it at some point in their lifetime. At least 1 in 10 US adults experience chronic or disabling tinnitus, with a significant negative impact on quality of life, often affecting sleep, concentration, mood, and hearing ability. Tinnitus can be intermittent or constant in nature, and intensity can vary or be exacerbated by stress, noise exposure, or other factors. Currently, there is no widely applicable cure for tinnitus, and management typically includes use of sound therapy, mental health counseling, lifestyle modifications, stress management, and distraction techniques. Tinnitus is associated with changes in auditory function, with hearing loss being the most commonly associated co-morbidity in patients. However, tinnitus can also be observed in patients with normal hearing.

Tinnitus can have a significant deleterious effect on a person's quality of life, and there is currently no cure. State-of-the art treatment options suffer limitations and are often ineffective and complex. Most widely used tinnitus treatments focus on reducing awareness of tinnitus/masking symptoms and the impact on emotional state rather than seeking to address the underlying mechanisms of the sound generation. Treatment modalities include sound therapy using environmental sounds and/or hearing aids, psychological interventions including tinnitus retraining therapy and/or cognitive behavioral therapy, somatosensory stimulation including vagus nerve stimulation and osteopathic manipulation, and distraction exercises including guided breathing and development of new hobbies. Other therapies aim to target the generation of tinnitus, including direct and indirect stimulation of the auditory cortex and/or other brain structures through neuromodulation and pharmacologic intervention. Despite the limited success of many of these treatment modalities, none have been shown to be widely applicable to manage tinnitus severity or provide a treatment for tinnitus.

Modifying temperature of the cochlea is known to influence auditory responses. The study team and others have shown that MTH delivered locally or systemically protects hearing function and cochlear structures against noise-induced hearing loss when compared to normothermic animals. It has also been shown in preclinical studies that MTH is safe. Lamprecht and Morgenstern first observed changes in tinnitus intensity in response to warm and cool caloric irrigations, and they found irrigation with warm (44ºC) water was associated with a perceptual increase in tinnitus, while irrigation with cool (30ºC) water was associated with a perceptual decrease in tinnitus. Recently, the idea of using cool water irrigation to reduce tinnitus was further explored. They found that irrigation with cool water resulted in a decrease in tinnitus perception as well as tinnitus disturbance as measured by the Tinnitus Handicap Inventory (THI).

In this study, investigators aim to show the efficacy of a highly accessible and translatable, non-invasive treatment strategy and device utilizing mild therapeutic hypothermia, or MTH, to reduce tinnitus symptom severity in patients with chronic tinnitus. The study team has designed and manufactured the headband-style device, ReBound, to provide therapeutic hypothermia to the inner ear structures. The aims of the study are:

Aim 1: Ascertain the effects of MTH in chronic tinnitus patients using questionnaires measuring tinnitus severity and intervention-related change. After collection of validated subjective assessments (adapted tinnitus Visual Analog Scale (VAS)) MTH will be delivered bilaterally for 30 minutes in a home setting using custom cold packs placed securely on the temporal bone. Half of the participants will receive a placebo treatment via sham devices. Pre- and post-assessments will be compared between normothermic (sham) and MTH-treated patients at completion of treatment and 24-hours post-treatment. Any adverse events (caloric activation of the vestibular system, skin frostbite) will be closely monitored by an audiologist. Results of Aim 1 will establish MTH as a novel approach for tinnitus symptom management.

Aim 2: Ascertain the comfort and acceptability of the device and therapy. Participants will be given a 6-question Device Acceptance Questionnaire (DAQ) in their post-assessment detailing their subjective experience of the comfort and acceptability of the therapy. They will rate their experience with the ease of use, comfort, and overall satisfaction with the device on a scale of 1-4.

This study will be completed entirely remotely and asynchronously in participants' homes. This research will be highly impactful given the significant adverse effects of tinnitus, an unmet clinical need, and the high translational potential of MTH for managing tinnitus severity.

Eligibility criteria: Inclusion Criteria:

* Adults 18-55 years of age at the time of signing the informed consent form with primary complaint of tinnitus;
* Suffering from subjective tinnitus for at least 30 days;
* Tinnitus whose level of severity is defined by Tinnitus Handicap Inventory (THI) values ≥12,
* Tinnitus is constant in nature (defined as audible at least 75% of waking hours).

Exclusion Criteria:

* Very mild tinnitus (THI values \<12);
* Tinnitus that is intermittent in nature;
* Tinnitus described as non-auditory or pulsatile in nature;
* Individuals with a history of vertigo or fluctuating hearing loss, such as that related to Menière's disease, chronic otitis, vestibular neuritis, neuroma, otosclerosis cholesteatoma, or temporomandibular joint disorder;
* Individuals with a history of extreme sensitivity to cold or heat, including individuals with a past history of frostbite or Raynaud's Syndrome.
* Those who are currently receiving medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions, including sound therapy, cognitive behavioral therapy (CBT), Tinnitus Retraining Therapy (TRT), steroid injections, or other treatments;
* Those who present with a mental health score indicating significant psychological component, per standard of care, based on PHQ-4 score of moderate to severe anxiety/depression.
* Children (under 18 years), incarcerated individuals, adults unable to consent, and psychologically vulnerable participants.

Primary outcomes:
measure: Subjective Tinnitus Severity
timeFrame: Immediately prior to and immediately after treatment or sham treatment.
Secondary outcomes:
measure: Perceived Improvement of Tinnitus Symptoms
timeFrame: Immediately after treatment or sham treatment.
measure: Comfort and Acceptability Questionnaire
timeFrame: Immediately after treatment in the Experimental Arm.
measure: Adverse Events Questionnaire
timeFrame: Immediately after treatment or sham treatment.
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: RestorEar Devices
state: Montana
Study officials:
affiliation: RestorEar Devices
name: Suhrud Rajguru, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: RestorEar Devices
name: Kendall Stern, MPH
role: PRINCIPAL_INVESTIGATOR
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