TinnitusNCT07017998
External Therapy for Tinnitus Management
A study testing Cold pack-delivered mild therapeutic hypothermia in people with Tinnitus and Tinnitus, Subjective, run by Restorear Devices LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Tinnitus, Tinnitus, Subjective
- What is being tested?
- Cold pack-delivered mild therapeutic hypothermia
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
RestorEar Devices
Bozeman, Montana, 59715
Kendall Stern, MPH, (406) 414-6278, kendall.stern@restorear.com
Suhrud Rajguru, PhD
About this study
Official title: Mild Therapeutic Hypothermia for Tinnitus Management
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:
- Ascertain the effects of MTH in chronic tinnitus patients using questionnaires measuring tinnitus severity and intervention-related change.
- 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.
Read the 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.
- Conditions
- Tinnitus, Tinnitus, Subjective
- Being tested
- Cold pack-delivered mild therapeutic hypothermia, Sham (No Treatment)
- Keywords
- tinnitus, ringing in the ears, ringing ears, symptom management, cooling, red light therapy
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold pack-delivered mild therapeutic hypothermiaDevice
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)Device
Sham headband-style device will be worn for 30 minutes. Participants will be told they are receiving therapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | 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 Receives: Device: Cold pack-delivered mild therapeutic hypothermia |
| Control Arm | Sham comparator | 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 Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Tinnitus Severity
An adapted 4-question visual analog scale (VAS) will be used to assess tinnitus awareness, loudness, tolerance and disturbance before baseline treatment and repeated immediately after application using the online survey module. The VAS has been adapted to address the current, acute subjective experience of the participants' tinnitus rather than their general experience. The VAS consists of a sliding scale from 0 to 100, with 100 correlating to a greater disease burden/worse symptoms.
Measured: Immediately prior to and immediately after treatment or sham treatment.
Secondary outcomes (3)
Perceived Improvement of Tinnitus Symptoms
The Patient Global Impression of Improvement (PGI-I) scale will be administered immediately post-treatment using the online survey module. This scale will allow participants to rank, subjectively, how their tinnitus compares after treatment versus to before. The PGI-I is a written rather than numerical scale, with potential values ranging from "very much better" to "very much worse".
Measured: Immediately after treatment or sham treatment.
Comfort and Acceptability Questionnaire
A 6-item Device Acceptance Questionnaire (DAQ) will be used to assess the comfort and acceptability of the therapy (Aim 2). DAQ will be administered immediately after treatment in the experimental group. The DAQ consists of Likert scale questions pertaining to the comfort of the device, with responses including: "strongly disagree", "disagree", "agree", and "strongly agree".
Measured: Immediately after treatment in the Experimental Arm.
Adverse Events Questionnaire
A 2-question Adverse Event Questionnaire (AEQ) will be administered immediately post-treatment to record any mild adverse events associated with the therapy, including headache, dizziness, or irritation. Participants will identify adverse events they experienced from a provided list, with the option to add their own.
Measured: Immediately after treatment or sham treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start16 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 and to respond to questions about their tinnitus experience.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Restorear Devices LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suhrud Rajguru, PhD, Principal investigator, RestorEar DevicesKendall Stern, MPH, Principal investigator, RestorEar Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017998
- Sponsor's protocol ID
- IRB-FY2025-39
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 3968937Rincon 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.
PubMed 38292902Rincon 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.
PubMed 38298897Tamames 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.
PubMed 29240567Tamames 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.
PubMed 27260269Henry 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.
PubMed 12742241Watanabe 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.
PubMed 11226700Henry 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.
PubMed 6401081Meisel-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.
PubMed 896576Liberman 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.
PubMed 6511672Brown 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.
PubMed 6863743Eggermont 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.
PubMed 22798948Sheldrake 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.
PubMed 26029161Sanchez 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.
PubMed 16446955
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Therapeutic Hypothermia for Tinnitus Management
- ClinicalTrials.gov ID
- NCT07017998
- Acronym / sponsor ID
- IRB-FY2025-39
- Conditions
- Tinnitus, Tinnitus, Subjective
- Keywords
- tinnitus, ringing in the ears, ringing ears, symptom management, cooling, red light therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Restorear Devices LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Ascertain the effects of MTH in chronic tinnitus patients using questionnaires measuring tinnitus severity and intervention-related change.
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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 and to respond to questions about their tinnitus experience.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Device: Cold pack-delivered mild therapeutic hypothermiaParticipants 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 |
| Control Arm | Sham comparator | Device: Sham (No Treatment)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 may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold pack-delivered mild therapeutic hypothermiaMild therapeutic hypothermia (cooling), delivered non-invasively to the structures of the inner ear (cochlea) for 30 minutes, using headband-style proprietary device, ReBound. | Device | Experimental Arm |
| Sham (No Treatment)Sham headband-style device will be worn for 30 minutes. Participants will be told they are receiving therapy. | Device | Control Arm |
Primary outcome
Subjective Tinnitus Severity
Time frame: Immediately prior to and immediately after treatment or sham treatment.
An adapted 4-question visual analog scale (VAS) will be used to assess tinnitus awareness, loudness, tolerance and disturbance before baseline treatment and repeated immediately after application using the online survey module. The VAS has been adapted to address the current, acute subjective experience of the participants' tinnitus rather than their general experience. The VAS consists of a sliding scale from 0 to 100, with 100 correlating to a greater disease burden/worse symptoms.
3 secondary outcomes
Perceived Improvement of Tinnitus Symptoms
Time frame: Immediately after treatment or sham treatment.
Comfort and Acceptability Questionnaire
Time frame: Immediately after treatment in the Experimental Arm.
Adverse Events Questionnaire
Time frame: Immediately after treatment or sham treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- BackgroundSaatci, 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.
- Background: PubMed 3968937Lamprecht 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.
- Background: PubMed 38292902Rincon 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.
- Background: PubMed 38298897Rincon 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.
- Background: PubMed 29240567Tamames 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.
- Background: PubMed 27260269Tamames 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.
- Background: PubMed 12742241Henry 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.
- Background: PubMed 11226700Watanabe 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.
- Background: PubMed 6401081Henry 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.
- Background: PubMed 896576Meisel-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.
- Background: PubMed 6511672Liberman 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.
- Background: PubMed 6863743Brown 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suhrud Rajguru, PhD principal investigator
RestorEar Devices
Kendall Stern, MPH principal investigator
RestorEar Devices
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold pack-delivered mild therapeutic hypothermia in people with Tinnitus and Tinnitus, Subjective, run by Restorear Devices LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kendall Stern, MPH (2068187219, kendall.stern@restorear.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Tinnitus Severity (time frame: Immediately prior to and immediately after treatment or sham treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07017998, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.