Study Results
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Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-11-24
2027-05-31
Brief Summary
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1. Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device.
2. Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device.
Participants will wear the ReBound hypothermia device for 30 minutes in a single session. Researchers will compare results from those receiving the therapy to those from a control group (sham therapy). Participants will also use the device in-home for 6 months and monitor their symptoms with online surveys.
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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 \[4\]. 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 pharmacologics \[5\]. 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. Further, systematic reviews have failed to demonstrate a strong evidence base for these approaches \[1\]. Many treatments and strategies currently in research are costly in terms of both time and resources, reducing sufferers' access or their ability to continue treatment over time. For those who do not find relief from their debilitating symptoms, and for those seeking to address secondary effects of tinnitus, there exists a need for novel treatment aimed at reducing acute tinnitus severity \[6\].
The investigators propose to show the efficacy of a highly accessible and translatable, non-invasive device utilizing mild therapeutic hypothermia, or MTH, to reduce tinnitus severity in participants with tinnitus. Unlike other approaches, MTH will address the physiological mechanisms of tinnitus and is easily deployable for routine use and symptom management. With support from a prior SBIR Phase I award, the investigators have designed and manufactured the headband-style device, ReBoundTM, to provide therapeutic hypothermia to the inner ear structures. Modifying temperature of the cochlea is known to influence auditory responses \[7-12\]. The investigators 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 \[13\]. The present study builds upon strong preliminary and published results of MTH treatment in the inner ear \[14, 15\] and two additional new publications \[16, 17\].
The goal of this interventional clinical study is to establish mild therapeutic hypothermia, delivered non-invasively to the structures of the inner ear, as a safe and repeatable therapeutic method for symptomatic relief of tinnitus. The study will assess both objective and subjective measures to address two main aims:
1. Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device.
2. Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device.
Participants will wear the ReBound hypothermia device for 30 minutes in a single session. Researchers will compare results from those receiving the therapy to those from a control group (sham therapy). Participants will also use the device in-home for 6 months and monitor their symptoms with online surveys.
This research will be highly impactful given the significant adverse effects of tinnitus, an unmet clinical need, on a broad population, and the high translational potential of MTH for reducing tinnitus symptoms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mild Therapeutic Hypothermia (MTH) Arm
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.
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
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.
Sham device
Sham headband-style device. Participants assigned to use this device will be told they are receiving therapy for 30 minutes. However, no therapy is being provided.
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 device
Sham headband-style device. Participants assigned to use this device will be told they are receiving therapy for 30 minutes. However, no therapy is being provided.
Eligibility Criteria
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Inclusion Criteria
* Fluency in English or Spanish
* Chronic subjective tinnitus for more than 30 days defined as audible at least 75% of waking hours
* At least mild tinnitus, score ≥18 on the Tinnitus Handicap Inventory (THI)
Exclusion Criteria
* Tinnitus described as non-auditory or pulsatile in nature
* Catastrophic tinnitus, score ≥78 on the THI
* Tinnitus that is intermittent in nature
* Abnormal tympanometric findings
* Presence of conductive component as characterized by air-bone gaps ≥15 dB at two or more consecutive frequencies
* Otologic pathologies (including, but not limited to): acoustic neuroma/ vestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity
* Temporomandibular joint disorder
* Those who are currently receiving medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions.
* Active hearing aid use
* Dizziness at the time of signing the consent form or at the time of starting the study protocol treatment
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
Restorear Devices LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Suhrud M Rajguru, PhD
Role: PRINCIPAL_INVESTIGATOR
RestorEar Devices
Locations
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University of Miami
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Ohlemiller KK, Siegel JH. Cochlear basal and apical differences reflected in the effects of cooling on responses of single auditory nerve fibers. Hear Res. 1994 Nov;80(2):174-90. doi: 10.1016/0378-5955(94)90109-0.
Ohlemiller KK, Siegel JH. The effects of moderate cooling on gross cochlear potentials in the gerbil: basal and apical differences. Hear Res. 1992 Nov;63(1-2):79-89. doi: 10.1016/0378-5955(92)90076-y.
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.
Kleinjung T, Langguth B. Avenue for Future Tinnitus Treatments. Otolaryngol Clin North Am. 2020 Aug;53(4):667-683. doi: 10.1016/j.otc.2020.03.013. Epub 2020 May 4.
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.
Atik A. Pathophysiology and treatment of tinnitus: an elusive disease. Indian J Otolaryngol Head Neck Surg. 2014 Jan;66(Suppl 1):1-5. doi: 10.1007/s12070-011-0374-8. Epub 2011 Dec 15.
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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20250377
Identifier Type: -
Identifier Source: org_study_id
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