Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-07-16
2026-12-01
Brief Summary
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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 therapy to those from a control group.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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 and to respond to questions about their tinnitus experience.
TREATMENT
SINGLE
Study Groups
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Experimental Arm
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
Cold pack-delivered mild therapeutic hypothermia
Mild therapeutic hypothermia (cooling), delivered non-invasively to the structures of the inner ear (cochlea) for 30 minutes, using headband-style proprietary device, ReBound.
Control Arm
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
Sham (No Treatment)
Sham headband-style device will be worn for 30 minutes. Participants will be told they are receiving therapy.
Interventions
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Cold pack-delivered mild therapeutic hypothermia
Mild therapeutic hypothermia (cooling), delivered non-invasively to the structures of the inner ear (cochlea) for 30 minutes, using headband-style proprietary device, ReBound.
Sham (No Treatment)
Sham headband-style device will be worn for 30 minutes. Participants will be told they are receiving therapy.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Restorear Devices LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Suhrud Rajguru, PhD
Role: PRINCIPAL_INVESTIGATOR
RestorEar Devices
Kendall Stern, MPH
Role: PRINCIPAL_INVESTIGATOR
RestorEar Devices
Locations
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RestorEar Devices
Bozeman, Montana, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Saatci, O., O.A. Duz, and N.G.Y. Aslier, Efficacy of caloric vestibular stimulation for the treatment of idiopathic tinnitus. Journal of Surgery and Medicine, 2020. 4(11): p. 1041-1045.
Lamprecht J, Morgenstern C. [Bilateral caloric long-term irrigation as a method for the differentiation of tonal tinnitus]. Laryngol Rhinol Otol (Stuttg). 1985 Jan;64(1):17-20. German.
Rincon Sabatino S, Rivero A, Sangaletti R, Dietrich WD, Hoffer ME, King CS, Rajguru SM. Targeted therapeutic hypothermia protects against noise induced hearing loss. Front Neurosci. 2024 Jan 16;17:1296458. doi: 10.3389/fnins.2023.1296458. eCollection 2023.
Rincon Sabatino S, Sangaletti R, Griswold A, Dietrich WD, King CS, Rajguru SM. Transcriptional response to mild therapeutic hypothermia in noise-induced cochlear injury. Front Neurosci. 2024 Jan 17;17:1296475. doi: 10.3389/fnins.2023.1296475. eCollection 2023.
Tamames I, King C, Huang CY, Telischi FF, Hoffer ME, Rajguru SM. Theoretical Evaluation and Experimental Validation of Localized Therapeutic Hypothermia Application to Preserve Residual Hearing After Cochlear Implantation. Ear Hear. 2018 Jul/Aug;39(4):712-719. doi: 10.1097/AUD.0000000000000529.
Tamames I, King C, Bas E, Dietrich WD, Telischi F, Rajguru SM. A cool approach to reducing electrode-induced trauma: Localized therapeutic hypothermia conserves residual hearing in cochlear implantation. Hear Res. 2016 Sep;339:32-9. doi: 10.1016/j.heares.2016.05.015. Epub 2016 May 31.
Henry KR. Hyperthermia exacerbates and hypothermia protects from noise-induced threshold elevation of the cochlear nerve envelope response in the C57BL/6J mouse. Hear Res. 2003 May;179(1-2):88-96. doi: 10.1016/s0378-5955(03)00097-2.
Watanabe F, Koga K, Hakuba N, Gyo K. Hypothermia prevents hearing loss and progressive hair cell loss after transient cochlear ischemia in gerbils. Neuroscience. 2001;102(3):639-45. doi: 10.1016/s0306-4522(00)00510-8.
Henry KR, Chole RA. Hypothermia protects the cochlea from noise damage. Hear Res. 1984 Dec;16(3):225-30. doi: 10.1016/0378-5955(84)90111-4.
Meisel-Mikolajczyk F, Swoboda-Kopec E, Skoskiewicz M. [Isolation of Bacteroides fragilis from the appendix in a case of appendicitis]. Pol Tyg Lek. 1977 Aug 1;32(31):1209-10. No abstract available. Polish.
Liberman MC, Dodds LW. Single-neuron labeling and chronic cochlear pathology. II. Stereocilia damage and alterations of spontaneous discharge rates. Hear Res. 1984 Oct;16(1):43-53. doi: 10.1016/0378-5955(84)90024-8.
Brown MC, Smith DI, Nuttall AL. The temperature dependency of neural and hair cell responses evoked by high frequencies. J Acoust Soc Am. 1983 May;73(5):1662-70. doi: 10.1121/1.389387.
Eggermont JJ, Roberts LE. The neuroscience of tinnitus: understanding abnormal and normal auditory perception. Front Syst Neurosci. 2012 Jul 11;6:53. doi: 10.3389/fnsys.2012.00053. eCollection 2012. No abstract available.
Sheldrake J, Diehl PU, Schaette R. Audiometric characteristics of hyperacusis patients. Front Neurol. 2015 May 15;6:105. doi: 10.3389/fneur.2015.00105. eCollection 2015.
Sanchez TG, Medeiros IR, Levy CP, Ramalho Jda R, Bento RF. Tinnitus in normally hearing patients: clinical aspects and repercussions. Braz J Otorhinolaryngol. 2005 Jul-Aug;71(4):427-31. doi: 10.1016/s1808-8694(15)31194-0. Epub 2005 Dec 15.
Baguley D, McFerran D, Hall D. Tinnitus. Lancet. 2013 Nov 9;382(9904):1600-7. doi: 10.1016/S0140-6736(13)60142-7. Epub 2013 Jul 2.
Other Identifiers
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IRB-FY2025-39
Identifier Type: -
Identifier Source: org_study_id
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