Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-31 @ 9:47 AM
Study NCT ID:
NCT06729632
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2024-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006317', 'term': 'Hearing Loss, Noise-Induced'}, {'id': 'D000097942', 'term': 'Hearing Loss, Hidden'}, {'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Aim 1 studies will use a crossover study design. Aim 2 studies will use a parallel model.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2024-12-09', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pure Tone Audiometry', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Distortion Product Otoacoustic Emissions', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Adverse Event Questionnaire', 'timeFrame': 'Immediately post-treatment; 3-hours and 24-hours post-treatment.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Device Acceptance Questionnaire', 'timeFrame': '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', 'description': '11 question survey about subjective experience and acceptance of the treatment. Includes Likert Scale questions about comfort, likelihood of use of the device, etc.'}, {'measure': 'Weekly Use Surveys', 'timeFrame': 'Weekly, from enrollment to end of treatment at 52 weeks.', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['hearing preservation', 'hearing loss', 'noise-induced hearing loss', 'noise exposure', 'mild therapeutic hypothermia', 'cooling', 'post-exposure', 'prevention'], 'conditions': ['Noise Exposure', 'Noise-induced Hearing Loss', 'Noise; Adverse Effect', 'Mild Therapeutic Hypothermia', 'Cooling', 'Occupational Exposure', 'Occupational Health', 'Hidden Hearing Loss']}, 'referencesModule': {'references': [{'pmid': '29703266', 'type': 'BACKGROUND', 'citation': 'Presneill J, Gantner D, Nichol A, McArthur C, Forbes A, Kasza J, Trapani T, Murray L, Bernard S, Cameron P, Capellier G, Huet O, Newby L, Rashford S, Rosenfeld JV, Smith T, Stephenson M, Varma D, Vallance S, Walker T, Webb S, James Cooper D; POLAR investigators and the ANZICS Clinical Trials Group. Statistical analysis plan for the POLAR-RCT: The Prophylactic hypOthermia trial to Lessen trAumatic bRain injury-Randomised Controlled Trial. Trials. 2018 Apr 27;19(1):259. doi: 10.1186/s13063-018-2610-y.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Nadon, V. and J. 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The main aims of the study are:\n\n1. To test the safety and best duration for use for a new hypothermia device.\n2. To determine if the hypothermia device helps decrease noise-induced hearing loss in a group of firefighters.\n\nParticipants 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).', 'detailedDescription': '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.\n\nCurrently 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.\n\nAim 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.\n\nAim 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18-55 years old at the time of signing the consent form\n* Fluency in English\n\nExclusion Criteria:\n\n* Abnormal tympanometric findings\n* Abnormal pure tone audiometry from 500-8,000 Hz (Non-firefighters only)\n* Significant history of noise exposure (Non-firefighters only)\n* Temporomandibular joint disorder\n* Otologic pathologies (including, but not limited to): acoustic neuroma/vestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity\n* Current recipients of medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions\n* Active hearing aid users\n* Adults unable to consent"}, 'identificationModule': {'nctId': 'NCT06729632', 'briefTitle': 'Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss', 'organization': {'class': 'INDUSTRY', 'fullName': 'Restorear Devices LLC'}, 'officialTitle': 'Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss', 'orgStudyIdInfo': {'id': 'DC018760'}, 'secondaryIdInfos': [{'id': '2R44DC018760-02A1', 'link': 'https://reporter.nih.gov/quickSearch/2R44DC018760-02A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safety Arm', 'description': '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.', 'interventionNames': ['Device: Cold pack-delivered mild therapeutic hypothermia']}, {'type': 'EXPERIMENTAL', 'label': 'Efficacy Arm 1 - Treatment', 'description': '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.', 'interventionNames': ['Device: Cold pack-delivered mild therapeutic hypothermia']}, {'type': 'NO_INTERVENTION', 'label': 'Efficacy Arm 2 - Non-Therapeutic', 'description': '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.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Efficacy Arm 3 - Control', 'description': '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.', 'interventionNames': ['Device: Cold pack-delivered mild therapeutic hypothermia']}], 'interventions': [{'name': 'Cold pack-delivered mild therapeutic hypothermia', 'type': 'DEVICE', 'description': 'Mild therapeutic hypothermia (cooling), delivered non-invasively to the structures of the inner ear (cochlea) for 30 minutes, using headband-style proprietary device, ReBoundRx.', 'armGroupLabels': ['Efficacy Arm 1 - Treatment', 'Efficacy Arm 3 - Control', 'Safety Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Suhrud M Rajguru, PhD', 'role': 'CONTACT', 'email': 'srajguru@restorear.com', 'phone': '801-641-8180'}, {'name': 'Suhrud M Rajguru, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hillary Snapp, AuD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Hoffer, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Suhrud M Rajguru, PhD', 'role': 'CONTACT', 'email': 'srajguru@restorear.com', 'phone': '801-641-8180'}, {'name': 'Curtis S King', 'role': 'CONTACT', 'email': 'cking@restorear.com', 'phone': '406-414-6278'}], 'overallOfficials': [{'name': 'Suhrud M Rajguru, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RestorEar Devices'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Restorear Devices LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Miami', 'class': 'OTHER'}, {'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}