[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572158":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":71,"collaborators":73,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":22,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":22,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":105,"overallStatus":51,"whyStopped":22,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Restorear Devices LLC","INDUSTRY",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: Cold pack-delivered mild therapeutic hypothermia",{"label":15,"type":10,"description":16,"interventionNames":17},"Efficacy Arm 1 - Treatment","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.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"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.",null,{"label":24,"type":25,"description":26,"interventionNames":27},"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.",[13],[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":22},"DEVICE","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, ReBoundRx.",[15,24,9],[35],{"name":36,"affiliation":37,"role":38},"Suhrud M Rajguru, PhD","RestorEar Devices","PRINCIPAL_INVESTIGATOR",[40,44],{"name":36,"role":41,"phone":42,"phoneExt":22,"email":43},"CONTACT","801-641-8180","srajguru@restorear.com",{"name":45,"role":41,"phone":46,"phoneExt":22,"email":47},"Curtis S King","406-414-6278","cking@restorear.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University of Miami","RECRUITING","Miami","Florida","33136","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-80.19366,25.77427,{"lat":61,"lon":60},[64,65,66,69],{"name":36,"role":41,"phone":42,"phoneExt":22,"email":43},{"name":36,"role":38,"phone":22,"phoneExt":22,"email":22},{"name":67,"role":68,"phone":22,"phoneExt":22,"email":22},"Hillary Snapp, AuD","SUB_INVESTIGATOR",{"name":70,"role":68,"phone":22,"phoneExt":22,"email":22},"Michael Hoffer, MD",{"type":72,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[74,76],{"name":50,"class":75},"OTHER",{"name":77,"class":78},"National Institute on Deafness and Other Communication Disorders (NIDCD)","NIH","100572158","non-invasive-system-to-deliver-therapeutic-hypothermia-for-protection-against-noise-induced-hearing-loss-100572158",false,"NCT06729632","Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss","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\u002Fvestibular 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",true,"ALL","18 Years","55 Years",{"count":90,"type":91},116,"ESTIMATED","INTERVENTIONAL",[94],"NA","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:\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).",[97,98,99,100,101,102,103,104],"Noise Exposure","Noise-induced Hearing Loss","Noise; Adverse Effect","Mild Therapeutic Hypothermia","Cooling","Occupational Exposure","Occupational Health","Hidden Hearing Loss",[106,107,108,109,110,111,112,113],"hearing preservation","hearing loss","noise-induced hearing loss","noise exposure","mild therapeutic hypothermia","cooling","post-exposure","prevention","2025-03-28",{"date":116,"type":117},"2025-04-02","ACTUAL",{"date":119,"type":117},"2024-12-19",{"date":121,"type":91},"2026-12-31",{"name":5,"class":6},1]