Noise ExposureNCT06729632
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
A study testing Cold pack-delivered mild therapeutic hypothermia in people with Noise Exposure and Noise-induced Hearing Loss, run by Restorear Devices LLC at 1 site in United States.
Trial summary
The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for preservation of sensory structures in the cochlea after noise exposure. The main aims of the study are: 1. To test the safety and best duration for use for a new hypothermia device. 2. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Noise Exposure, Noise-induced Hearing Loss, Noise; Adverse Effect
- What is being tested?
- Cold pack-delivered mild therapeutic hypothermia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2024to 30 Sep 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-55 years old at the time of signing the consent form
- Fluency in English
Who cannot join
- Abnormal tympanometric findings
- Abnormal pure tone audiometry from 500-8,000 Hz (Non-firefighters only)
- Significant history of noise exposure (Non-firefighters only)
- Temporomandibular joint disorder
- Otologic pathologies (including, but not limited to): acoustic neuroma/vestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity
- Current recipients of medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions
- Active hearing aid users
- Adults unable to consent
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
University of Miami
Miami, Florida, 33136
Suhrud M Rajguru, PhD, 801-641-8180, srajguru@restorear.com
Suhrud M Rajguru, PhD
About this study
The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for preservation of sensory structures in the cochlea after noise exposure. The main aims of the study are:
- To test the safety and best duration for use for a new hypothermia device.
- To determine if the hypothermia device helps decrease noise-induced hearing loss in a group of firefighters.
Participants will wear the mild therapeutic hypothermia therapy devices immediately after a fire service shift serially over a year. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy and a sham therapy).
Read the detailed description
Noise-induced hearing loss (NIHL) is highly prevalent among occupationally at-risk service groups like the military and firefighters, with disabilities that result in significant healthcare burden, negatively impacting performance on duty and quality of life. Exposure to noise can cause permanent threshold shifts (PTS) with accompanying hair cell loss, or temporary threshold shifts (TTS), with no evident hair cell loss. Noise exposure can also result in rapid and permanent loss of synaptic elements and cochlear nerve terminals with irreversible hearing impairment and long-term degeneration of spiral ganglion (SG) cell bodies.
Currently no FDA-approved treatments are available to prevent or treat NIHL. Delivering pharmaceutical compounds over time, identification of safe dosages, and a critical timeframe relative to noise-exposure remain clinically challenging. RestorEar Devices LLC has developed a non-pharmaceutical application of mild therapeutic hypothermia (MTH) to protect residual sensory structures and function of the cochlea. MTH is a proven and well-established therapy for neuroprotection. This approach for MTH application is based on significant prior and on-going research that highlights its utility for residual hearing preservation against cochlear implant surgical trauma, ototoxicity, and noise exposure. With SBIR Phase I support, the investigators have successfully demonstrated that effective non-invasive, non-pharmaceutical therapeutic hypothermia can be delivered to the inner ear sensory structures. The investigators have built, calibrated, and tested ReBoundTM, a headband with cooling gel packs placed in contact with the surface of the mastoid. ReBoundTM delivers MTH safely and repeatedly for up to 30 minutes. In this study, the investigators aim to extend this application to human subjects and test safety and efficacy against NIHL in noise-exposed firefighters and matched controls with the collaboration of researchers at the University of Miami.
Aim 1: Evaluate safety of MTH with ReBoundTM devices. With the first in-human studies, the investigators aim to show that MTH can be safely delivered to the inner ear using ReBound. In a randomized study, non-firefighter control subjects will receive MTH-treatment and normothermia-sham (non-cooled gel pack) through the device alternated over 8 sessions. Subjective assessments and audiologic testing (pure tone audiometry, auditory brainstem responses, distortion product otoacoustic emissions and electrocochleography) pre- and post-treatments will be compared between MTH-treatment and sham in each subject. Results of Aim 1 will support the hypothesis that this approach will deliver therapeutic hypothermia to the cochleae and that repeated application will not negatively affect hearing function in healthy subjects.
Aim 2: Validate efficacy of the ReBoundTM MTH devices for mitigating NIHL in an occupationally at-risk group. Based on strong preliminary results, the investigators hypothesize that acute application of MTH in noise-exposed firefighters will reduce temporary changes in auditory function. Firefighters will be divided equally into two treatment groups, MTH-treatment and normothermia-sham. These treatments will be delivered with ReBound, with and without cooled gel packs, applied post-duty. MTH-treatment will also be applied in an age- and sex-matched control group over the same duration. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and the functional assessments will be repeated quarterly over one year. Temporary and permanent threshold changes in this chronically the noise exposed group of firefighters receiving MTH-treatment will be compared with firefighters receiving sham-treatment and with controls receiving MTH-treatment. MTH-groups will also be sent home with a ReBound band and instructed to use it after noise exposure. Subjective assessments will be sent weekly to these groups to evaluate the use pattern of the device. Results of these studies will firmly establish MTH for mitigating NIHL.
This research will be highly impactful given the significant adverse effects of NIHL, an unmet clinical need, and the high translational potential of MTH for mitigating NIHL.
- Conditions
- Noise Exposure, Noise-induced Hearing Loss, Noise; Adverse Effect, Mild Therapeutic Hypothermia, Cooling, Occupational Exposure
- Being tested
- Cold pack-delivered mild therapeutic hypothermia
- Keywords
- hearing preservation, hearing loss, noise-induced hearing loss, noise exposure, mild therapeutic hypothermia, cooling, post-exposure, prevention
- Medical subject headings
- Hearing Loss, Noise-Induced, Hearing Loss, Hidden, Hearing Loss
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, ReBoundRx.
| Study group | Role | What they receive |
|---|---|---|
| Safety Arm | Experimental | Non-firefighter control subjects will receive MTH-treatment and normothermia-sham through the device alternated over 8 sessions. Subjective assessments and audiologic testing pre- and post-treatments will be compared between MTH-treatment and sham in each subject. n=24. Receives: Device: Cold pack-delivered mild therapeutic hypothermia |
| Efficacy Arm 1 - Treatment | Experimental | Firefighters will receive hypothermia treatment delivered with ReBound devices, applied post-work shift. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and functional assessments will be repeated quarterly over one year. Temporary and permanent threshold changes in this chronically noise exposed group of firefighters receiving MTH-treatment will be compared with firefighters receiving sham-treatment and with controls receiving MTH-treatment. Subjects in this group will also be sent home with a device to use after noise exposure during the study period. They will complete weekly, remote surveys collecting data on their noise exposure and device use. n=24. Receives: Device: Cold pack-delivered mild therapeutic hypothermia |
| Efficacy Arm 2 - Non-Therapeutic | No intervention | Firefighters will receive non-therapeutic "treatment" delivered with normothermic ReBound devices, applied post-work shift. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and functional assessments will be repeated quarterly over one year. n=24. |
| Efficacy Arm 3 - Control | Active comparator | Age- and sex-matched non-firefighter control group will receive MTH-treatment quarterly over the same duration. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and functional assessments will be repeated quarterly over one year. Subjects in this group will also be sent home with a device to use after noise exposure during the study period. They will complete weekly, remote surveys collecting data on their noise exposure and device use. n=24. Receives: Device: Cold pack-delivered mild therapeutic hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure Tone Audiometry
Pure Tone Audiometry (PTA) will be performed in the Safety and Efficacy arms immediately post-treatment. PTA will be performed at baseline and immediately post-treatment in the Safety Arm, 8 times over 4 weeks. In the Efficacy Arms, it will be completed quarterly before and immediately post-treatment.
Measured: Safety Arm: Twice per week, pre- and post- treatment, to the end of treatment at 4 weeks. Efficacy Arms: Every 3 months, pre- and post-treatment, for 1 year.
Distortion Product Otoacoustic Emissions
Distortion Product Otoacoustic Emissions (DPOAE) will be performed in the Safety and Efficacy Arms immediately post-treatment. DPOAE will be performed at baseline and immediately post-treatment in the Safety Arm, 8 times over 4 weeks. In the Efficacy Arms, it will be completed quarterly before and immediately post-treatment.
Measured: Safety Arm: Twice per week, pre- and post- treatment, to the end of treatment at 4 weeks. Efficacy Arms: Every 3 months, pre- and post-treatment, for 1 year.
Adverse Event Questionnaire
The 2 question Adverse Event Questionnaire (AEQ) will be administered in both the Safety and Efficacy Arms. It will collect data on any adverse event associated with use of the device.
Measured: Immediately post-treatment; 3-hours and 24-hours post-treatment.
Secondary outcomes (2)
Device Acceptance Questionnaire
11 question survey about subjective experience and acceptance of the treatment. Includes Likert Scale questions about comfort, likelihood of use of the device, etc.
Measured: Safety Arm: Post-initial treatment and at the end of week 4 post-enrollment; Efficacy Arms: Post-initial treatment and at the end of 12 months
Weekly Use Surveys
Experimental Efficacy Arm and Non-Firefighter Control Arms for Efficacy Study will complete weekly, 3 question survey monitoring the use of the device at home. Firefighters will be asked how many shifts they had that week and how many times they used the device. Non-firefighters will be asked about their noise exposure and device use.
Measured: Weekly, from enrollment to end of treatment at 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start19 Dec 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (101)Papers the sponsor has linked to this study.
- Other trials for Noise ExposureStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Aim 1 studies will use a crossover study design. Aim 2 studies will use a parallel model.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Restorear Devices LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Miami, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Suhrud M Rajguru, PhD, Principal investigator, RestorEar Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729632
- Sponsor's protocol ID
- DC018760
- Other IDs
- 2R44DC018760-02A1
- Status last verified
- Jul 2026
- First submitted
- 4 Dec 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Centre, A.a.N.Z.I.C.R., The Prophylactic Hypothermia Trial to Lessen Traumatic Brain Injury (POLAR-RCT), in ClinicalTrials.gov. 2017: https://clinicaltrials.gov/ct2/show/NCT00987688.
Hospital, R., Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury (LTH-Ⅰ), in ClinicalTrials.gov. 2017: https://www.clinicaltrials.gov/ct2/show/NCT01886222.
Azman, A.S. and R.L. Hudak, An evaluation of sound restoration hearing protection devices and audibility issues in mining. Noise Control Engineering Journal, 2011. 59(6): p. 622-630
Rabinowitz, P.M., The Public Health Significance of Noise-Induced Hearing Loss, in Noise-Induced Hearing Loss: Scientific Advances, C.G. LePrell, et al., Editors. 2012. p. 13-25.
Nadon, V. and J. Voix, Effects of noise exposure on hearing health evaluated through short interval otoacoustic emission monitoring: Preliminary results with low and moderate noise exposure groups. The Journal of the Acoustical Society of America, 2018. 144(3): p. 1789-1789
Thepaksorn, P., et al., Occupational hazard exposures and health risks at wooden toys industry in Southern Thailand. Human and Ecological Risk Assessment, 2020. 26(8): p. 2162-2172
Emara, A. and T. Gabr, Chronic noise exposure: impact on the vestibular function. Advanced Arab Academy of Audio-Vestibulogy Journal, 2014. 1(2): p. 71-79
Humes LE, J.L., Durch JS, Noise and military service: implications for hearing loss and tinnitus. Washington, DC: Institute of Medicine of the National Academies, 2005
Basner M, Babisch W, Davis A, Brink M, Clark C, Janssen S, Stansfeld S. Auditory and non-auditory effects of noise on health. Lancet. 2014 Apr 12;383(9925):1325-1332. doi: 10.1016/S0140-6736(13)61613-X. Epub 2013 Oct 30.
PubMed 24183105Hawkins JE Jr, Johnsson LG, Stebbins WC, Moody DB, Coombs SL. Hearing loss and cochlear pathology in monkeys after noise exposure. Acta Otolaryngol. 1976 Mar-Apr;81(3-4):337-43. doi: 10.3109/00016487609119971.
PubMed 817561Kujawa SG, Liberman MC. Synaptopathy in the noise-exposed and aging cochlea: Primary neural degeneration in acquired sensorineural hearing loss. Hear Res. 2015 Dec;330(Pt B):191-9. doi: 10.1016/j.heares.2015.02.009. Epub 2015 Mar 11.
PubMed 25769437Fernandez KA, Jeffers PW, Lall K, Liberman MC, Kujawa SG. Aging after noise exposure: acceleration of cochlear synaptopathy in "recovered" ears. J Neurosci. 2015 May 13;35(19):7509-20. doi: 10.1523/JNEUROSCI.5138-14.2015.
PubMed 25972177Yankaskas K. Prelude: noise-induced tinnitus and hearing loss in the military. Hear Res. 2013 Jan;295:3-8. doi: 10.1016/j.heares.2012.04.016. Epub 2012 May 2.
PubMed 22575206Liberman MC, Epstein MJ, Cleveland SS, Wang H, Maison SF. Toward a Differential Diagnosis of Hidden Hearing Loss in Humans. PLoS One. 2016 Sep 12;11(9):e0162726. doi: 10.1371/journal.pone.0162726. eCollection 2016.
PubMed 27618300Valderrama JT, Beach EF, Yeend I, Sharma M, Van Dun B, Dillon H. Effects of lifetime noise exposure on the middle-age human auditory brainstem response, tinnitus and speech-in-noise intelligibility. Hear Res. 2018 Aug;365:36-48. doi: 10.1016/j.heares.2018.06.003. Epub 2018 Jun 12.
PubMed 29913342
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
- ClinicalTrials.gov ID
- NCT06729632
- Acronym / sponsor ID
- DC018760
- Conditions
- Noise Exposure, Noise-induced Hearing Loss, Noise; Adverse Effect, Mild Therapeutic Hypothermia, Cooling, Occupational Exposure
- Keywords
- hearing preservation, hearing loss, noise-induced hearing loss, noise exposure, mild therapeutic hypothermia, cooling, post-exposure, prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Restorear Devices LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Miami, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 11 Dec 2024 (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 interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for preservation of sensory structures in the cochlea after noise exposure. The main aims of the study are:
- To test the safety and best duration for use for a new hypothermia device.
- To determine if the hypothermia device helps decrease noise-induced hearing loss in a group of firefighters.
Participants will wear the mild therapeutic hypothermia therapy devices immediately after a fire service shift serially over a year. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy and a sham therapy).
Detailed description
Noise-induced hearing loss (NIHL) is highly prevalent among occupationally at-risk service groups like the military and firefighters, with disabilities that result in significant healthcare burden, negatively impacting performance on duty and quality of life. Exposure to noise can cause permanent threshold shifts (PTS) with accompanying hair cell loss, or temporary threshold shifts (TTS), with no evident hair cell loss. Noise exposure can also result in rapid and permanent loss of synaptic elements and cochlear nerve terminals with irreversible hearing impairment and long-term degeneration of spiral ganglion (SG) cell bodies.
Currently no FDA-approved treatments are available to prevent or treat NIHL. Delivering pharmaceutical compounds over time, identification of safe dosages, and a critical timeframe relative to noise-exposure remain clinically challenging. RestorEar Devices LLC has developed a non-pharmaceutical application of mild therapeutic hypothermia (MTH) to protect residual sensory structures and function of the cochlea. MTH is a proven and well-established therapy for neuroprotection. This approach for MTH application is based on significant prior and on-going research that highlights its utility for residual hearing preservation against cochlear implant surgical trauma, ototoxicity, and noise exposure. With SBIR Phase I support, the investigators have successfully demonstrated that effective non-invasive, non-pharmaceutical therapeutic hypothermia can be delivered to the inner ear sensory structures. The investigators have built, calibrated, and tested ReBoundTM, a headband with cooling gel packs placed in contact with the surface of the mastoid. ReBoundTM delivers MTH safely and repeatedly for up to 30 minutes. In this study, the investigators aim to extend this application to human subjects and test safety and efficacy against NIHL in noise-exposed firefighters and matched controls with the collaboration of researchers at the University of Miami.
Aim 1: Evaluate safety of MTH with ReBoundTM devices. With the first in-human studies, the investigators aim to show that MTH can be safely delivered to the inner ear using ReBound. In a randomized study, non-firefighter control subjects will receive MTH-treatment and normothermia-sham (non-cooled gel pack) through the device alternated over 8 sessions. Subjective assessments and audiologic testing (pure tone audiometry, auditory brainstem responses, distortion product otoacoustic emissions and electrocochleography) pre- and post-treatments will be compared between MTH-treatment and sham in each subject. Results of Aim 1 will support the hypothesis that this approach will deliver therapeutic hypothermia to the cochleae and that repeated application will not negatively affect hearing function in healthy subjects.
Aim 2: Validate efficacy of the ReBoundTM MTH devices for mitigating NIHL in an occupationally at-risk group. Based on strong preliminary results, the investigators hypothesize that acute application of MTH in noise-exposed firefighters will reduce temporary changes in auditory function. Firefighters will be divided equally into two treatment groups, MTH-treatment and normothermia-sham. These treatments will be delivered with ReBound, with and without cooled gel packs, applied post-duty. MTH-treatment will also be applied in an age- and sex-matched control group over the same duration. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and the functional assessments will be repeated quarterly over one year. Temporary and permanent threshold changes in this chronically the noise exposed group of firefighters receiving MTH-treatment will be compared with firefighters receiving sham-treatment and with controls receiving MTH-treatment. MTH-groups will also be sent home with a ReBound band and instructed to use it after noise exposure. Subjective assessments will be sent weekly to these groups to evaluate the use pattern of the device. Results of these studies will firmly establish MTH for mitigating NIHL.
This research will be highly impactful given the significant adverse effects of NIHL, an unmet clinical need, and the high translational potential of MTH for mitigating NIHL.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Aim 1 studies will use a crossover study design. Aim 2 studies will use a parallel model.
| Arm | Type | Receives |
|---|---|---|
| Safety Arm | Experimental | Device: Cold pack-delivered mild therapeutic hypothermiaNon-firefighter control subjects will receive MTH-treatment and normothermia-sham through the device alternated over 8 sessions. Subjective assessments and audiologic testing pre- and post-treatments will be compared between MTH-treatment and sham in each subject. n=24. |
| Efficacy Arm 1 - Treatment | Experimental | Device: Cold pack-delivered mild therapeutic hypothermiaFirefighters will receive hypothermia treatment delivered with ReBound devices, applied post-work shift. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and functional assessments will be repeated quarterly over one year. Temporary and permanent threshold changes in this chronically noise exposed group of firefighters receiving MTH-treatment will be compared with firefighters receiving sham-treatment and with controls receiving MTH-treatment. Subjects in this group will also be sent home with a device to use after noise exposure during the study period. They will complete weekly, remote surveys collecting data on their noise exposure and device use. n=24. |
| Efficacy Arm 2 - Non-Therapeutic | No intervention | –Firefighters will receive non-therapeutic "treatment" delivered with normothermic ReBound devices, applied post-work shift. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and functional assessments will be repeated quarterly over one year. n=24. |
| Efficacy Arm 3 - Control | Active comparator | Device: Cold pack-delivered mild therapeutic hypothermiaAge- and sex-matched non-firefighter control group will receive MTH-treatment quarterly over the same duration. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and functional assessments will be repeated quarterly over one year. Subjects in this group will also be sent home with a device to use after noise exposure during the study period. They will complete weekly, remote surveys collecting data on their noise exposure and device use. n=24. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults aged 18-55 years old at the time of signing the consent form
- Fluency in English
Key exclusion criteria (8 listed)
- Abnormal tympanometric findings
- Abnormal pure tone audiometry from 500-8,000 Hz (Non-firefighters only)
- Significant history of noise exposure (Non-firefighters only)
- Temporomandibular joint disorder
- Otologic pathologies (including, but not limited to): acoustic neuroma/vestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity
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, ReBoundRx. | Device | Efficacy Arm 1 - Treatment, Efficacy Arm 3 - Control, Safety Arm |
Primary outcome
Pure Tone Audiometry
Time frame: Safety Arm: Twice per week, pre- and post- treatment, to the end of treatment at 4 weeks. Efficacy Arms: Every 3 months, pre- and post-treatment, for 1 year.
Pure Tone Audiometry (PTA) will be performed in the Safety and Efficacy arms immediately post-treatment. PTA will be performed at baseline and immediately post-treatment in the Safety Arm, 8 times over 4 weeks. In the Efficacy Arms, it will be completed quarterly before and immediately post-treatment.
Distortion Product Otoacoustic Emissions
Time frame: Safety Arm: Twice per week, pre- and post- treatment, to the end of treatment at 4 weeks. Efficacy Arms: Every 3 months, pre- and post-treatment, for 1 year.
Distortion Product Otoacoustic Emissions (DPOAE) will be performed in the Safety and Efficacy Arms immediately post-treatment. DPOAE will be performed at baseline and immediately post-treatment in the Safety Arm, 8 times over 4 weeks. In the Efficacy Arms, it will be completed quarterly before and immediately post-treatment.
Adverse Event Questionnaire
Time frame: Immediately post-treatment; 3-hours and 24-hours post-treatment.
The 2 question Adverse Event Questionnaire (AEQ) will be administered in both the Safety and Efficacy Arms. It will collect data on any adverse event associated with use of the device.
2 secondary outcomes
Device Acceptance Questionnaire
Time frame: Safety Arm: Post-initial treatment and at the end of week 4 post-enrollment; Efficacy Arms: Post-initial treatment and at the end of 12 months
Weekly Use Surveys
Time frame: Weekly, from enrollment to end of treatment at 52 weeks.
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 23 Jul 2026.
- BackgroundCentre, A.a.N.Z.I.C.R., The Prophylactic Hypothermia Trial to Lessen Traumatic Brain Injury (POLAR-RCT), in ClinicalTrials.gov. 2017: https://clinicaltrials.gov/ct2/show/NCT00987688.
- BackgroundHospital, R., Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury (LTH-Ⅰ), in ClinicalTrials.gov. 2017: https://www.clinicaltrials.gov/ct2/show/NCT01886222.
- BackgroundAzman, A.S. and R.L. Hudak, An evaluation of sound restoration hearing protection devices and audibility issues in mining. Noise Control Engineering Journal, 2011. 59(6): p. 622-630
- BackgroundRabinowitz, P.M., The Public Health Significance of Noise-Induced Hearing Loss, in Noise-Induced Hearing Loss: Scientific Advances, C.G. LePrell, et al., Editors. 2012. p. 13-25.
- BackgroundNadon, V. and J. Voix, Effects of noise exposure on hearing health evaluated through short interval otoacoustic emission monitoring: Preliminary results with low and moderate noise exposure groups. The Journal of the Acoustical Society of America, 2018. 144(3): p. 1789-1789
- BackgroundThepaksorn, P., et al., Occupational hazard exposures and health risks at wooden toys industry in Southern Thailand. Human and Ecological Risk Assessment, 2020. 26(8): p. 2162-2172
- BackgroundEmara, A. and T. Gabr, Chronic noise exposure: impact on the vestibular function. Advanced Arab Academy of Audio-Vestibulogy Journal, 2014. 1(2): p. 71-79
- BackgroundHumes LE, J.L., Durch JS, Noise and military service: implications for hearing loss and tinnitus. Washington, DC: Institute of Medicine of the National Academies, 2005
- Background: PubMed 24183105Basner M, Babisch W, Davis A, Brink M, Clark C, Janssen S, Stansfeld S. Auditory and non-auditory effects of noise on health. Lancet. 2014 Apr 12;383(9925):1325-1332. doi: 10.1016/S0140-6736(13)61613-X. Epub 2013 Oct 30.
- Background: PubMed 817561Hawkins JE Jr, Johnsson LG, Stebbins WC, Moody DB, Coombs SL. Hearing loss and cochlear pathology in monkeys after noise exposure. Acta Otolaryngol. 1976 Mar-Apr;81(3-4):337-43. doi: 10.3109/00016487609119971.
- Background: PubMed 25769437Kujawa SG, Liberman MC. Synaptopathy in the noise-exposed and aging cochlea: Primary neural degeneration in acquired sensorineural hearing loss. Hear Res. 2015 Dec;330(Pt B):191-9. doi: 10.1016/j.heares.2015.02.009. Epub 2015 Mar 11.
- Background: PubMed 25972177Fernandez KA, Jeffers PW, Lall K, Liberman MC, Kujawa SG. Aging after noise exposure: acceleration of cochlear synaptopathy in "recovered" ears. J Neurosci. 2015 May 13;35(19):7509-20. doi: 10.1523/JNEUROSCI.5138-14.2015.
- 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 M Rajguru, PhD 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 Noise Exposure and Noise-induced Hearing Loss, 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 2 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 23 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. 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 Suhrud M Rajguru, PhD (801-641-8180, srajguru@restorear.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pure Tone Audiometry (time frame: Safety Arm: Twice per week, pre- and post- treatment, to the end of treatment at 4 weeks. Efficacy Arms: Every 3 months, pre- and post-treatment, for 1 year.). The study lists 3 primary outcomes in all. 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 NCT06729632, which also lists 101 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 23 Jul 2026.