Trial Summary
What is the purpose of this trial?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. 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).
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are currently receiving treatment for tinnitus or other ear conditions, you may not be eligible to participate.
What data supports the idea that Therapeutic Hypothermia for Noise-Induced Hearing Loss is an effective treatment?The available research shows that therapeutic hypothermia has been effective in treating traumatic brain injuries by reducing harmful effects and improving outcomes. For example, one study found that slow rewarming after hypothermia improved neurological outcomes in patients with severe brain injuries. However, there is no specific data provided on its effectiveness for noise-induced hearing loss, so we can't directly compare it to other treatments for that condition.2391012
What safety data exists for therapeutic hypothermia for noise-induced hearing loss?The provided research does not contain any safety data related to therapeutic hypothermia for noise-induced hearing loss or its alternative names. The studies focus on hormone therapy and its effects, which are unrelated to the treatment in question.147814
Is the treatment Cold pack-delivered mild therapeutic hypothermia a promising treatment for noise-induced hearing loss?Yes, Cold pack-delivered mild therapeutic hypothermia is promising for noise-induced hearing loss. It helps protect hearing by slowing down body processes, reducing stress on cells, and possibly involving special proteins that respond to cold. This treatment has shown potential in protecting against different types of hearing loss.56111315
Eligibility Criteria
This trial is for firefighters who have been exposed to loud noise during their shifts and are at risk for noise-induced hearing loss. Participants should be willing to wear a hypothermia therapy device after their shifts over a year. Specific eligibility details are not provided, but typically, participants must meet certain health criteria and not have conditions that would exclude them from safely participating.Treatment Details
The study is testing a non-invasive hypothermia device applied using a cold pack to see if it can protect against hearing loss after noise exposure. Firefighters will use the device after their shifts, and their hearing will be compared to those who didn't receive the therapy or received a sham (fake) therapy.
4Treatment groups
Experimental Treatment
Active Control
Group I: Safety ArmExperimental Treatment1 Intervention
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.
Group II: Efficacy Arm 1 - TreatmentExperimental Treatment1 Intervention
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.
Group III: Efficacy Arm 2 - Non-TherapeuticActive Control1 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.
Group IV: Efficacy Arm 3 - ControlActive Control1 Intervention
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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of MiamiMiami, FL
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Who is running the clinical trial?
Restorear Devices LLCLead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)Collaborator
University of MiamiCollaborator
References
An oral regimen of cyproterone acetate and testosterone undecanoate for spermatogenic suppression in men. [2019]To test the effectiveness, safety, and reversibility of the combined administration of cyproterone acetate and T undecanoate.
Feasibility of the titration method of mild hypothermia in severely head-injured patients with intracranial hypertension. [2019]Clinical strategy to maximize effectiveness and to minimize adverse influences remains to be determined for mild hypothermia therapy for traumatic brain injury. This study was conducted to evaluate the clinical feasibility of the titration method of mild hypothermia in severely head-injured patients in whom a reduction in intracranial pressure was regarded as the target effect.
Secondary injuries in brain trauma: effects of hypothermia. [2019]Hypothermia has been shown to be cerebroprotective in traumatized brains. Although a large number of traumatic brain injury (TBI) studies in animals have shown that hypothermia is effective in suppressing a variety of damaging mechanisms, clinical investigations have shown less consistent results. The complexity of damaging mechanisms in human TBI may contribute to these discrepancies. In particular, secondary injuries such as hypotension and hypoxemia may promote poor outcome. However, few experimental TBI studies have employed complex models that included such secondary injuries to clarify the efficacy of hypothermia. This review discusses the effects of hypothermia in various TBI models addressing primary and acute secondary injuries. Included are recently published clinical data using hypothermia as a therapeutic tool for preventing or reducing the detrimental posttraumatic secondary injuries and neurobehavioral deficits. Also discussed are recent successful applications of hypothermia from outside the TBI realm. Based on all available data, some general considerations for the application of hypothermia in TBI patients are given.
Low and ultra low-dose estrogen therapy for climacteric symptom control--preliminary report. [2006]Recent clinical trials have caused physicians to reconsider the use of hormone therapy (HT). Low-dose therapy has been proposed for those patients who tolerate standard doses poorly.
Local hypothermia in the treatment of idiopathic sudden sensorineural hearing loss. [2013]The additive effects of local hypothermia and restricted activity in the treatment of idiopathic sudden sensorineural hearing loss (ISSHL) were investigated by case-matched study as a multicenter (13 hospitals) pilot trial.
Stridor in asphyxiated neonates undergoing therapeutic hypothermia. [2014]Therapeutic hypothermia is an established standard of care in the treatment of hypoxic-ischemic encephalopathy. Application of therapeutic hypothermia in the clinical setting may reveal a wider spectrum of adverse events than previously reported. We report 5 cases of transient respiratory stridor in 51 infants, occurring at different time points in the cooling process, which appeared to be unrelated to the intubation procedure. Therapeutic hypothermia was associated with transient stridor in this case series. Formal laryngoscopy is required to determine the underlying pathologic etiology.
Effect of transdermal hormone therapy on platelet haemostasis in menopausal women. [2018]Despite the undeniably positive effect on the quality of life of menopausal women, menopausal hormone therapy (HT) also has negative side-effects, which include, among others, thromboembolic complications.
Brain structure and cognition 3 years after the end of an early menopausal hormone therapy trial. [2021]The effects of 2 frequently used formulations of menopausal hormone therapy (mHT) on brain structure and cognition were investigated 3 years after the end of a randomized, placebo-controlled trial in recently menopausal women with good cardiovascular health.
Slow rewarming improved the neurological outcomes of prolonged mild therapeutic hypothermia in patients with severe traumatic brain injury and an evacuated hematoma. [2019]Mild therapeutic hypothermia (MTH) is expected to improve the neurological outcomes of patients with severe traumatic brain injury (TBI). However, there are no standard protocols for managing the temperature of patients with severe TBI in order to improve their neurological outcomes. We conducted a post hoc analysis of the B-HYPO study, a randomized controlled trial of MTH in patients with TBI in Japan. We evaluated the impact of MTH methods on neurological outcomes. Ninety-seven patients who received MTH were included in the present analyses. The neurological outcomes were compared among subgroups of patients divided by cutoff values for the induction, maintenance, and rewarming times of MTH in all patients, in patients with diffuse injury, and in patients with an evacuated hematoma. The proportion of patients with a good neurological outcome was significantly different between patients with an evacuated hematoma divided into subgroups by the cutoff value of rewarming time of 48 h (>48 h vs. ≤ 48 h: 65% vs. 22%; odds ratio: 6.61; 95% confidence interval: 1.13-38.7, P = 0.0498). Slow rewarming for >48 h might improve the neurological outcomes of prolonged MTH in patients with TBI and an evacuated hematoma. Further studies are needed to investigate the optimal rewarming protocol in patients with TBI.
Mild therapeutic hypothermia after out-of-hospital cardiac arrest: What does really matter? [2021]Mild therapeutic hypothermia (MTH) is a recommended treatment of comatose patients after out-of-hospital cardiac arrest (OHCA). The aim of the study was to examine determinants of clinical outcome in OHCA survivors treated with MTH and variables associated with MTH induction time.
Mild Therapeutic Hypothermia and Putative Mechanisms of Hair Cell Survival in the Cochlea. [2023]Significance: Sensorineural hearing loss has significant implications for quality of life and risk for comorbidities such as cognitive decline. Noise and ototoxic drugs represent two common risk factors for acquired hearing loss that are potentially preventable. Recent Advances: Numerous otoprotection strategies have been postulated over the past four decades with primary targets of upstream redox pathways. More recently, the application of mild therapeutic hypothermia (TH) has shown promise for otoprotection for multiple forms of acquired hearing loss. Critical Issues: Systemic antioxidant therapy may have limited application for certain ototoxic drugs with a therapeutic effect on redox pathways and diminished efficacy of the primary drug's therapeutic function (e.g., cisplatin for tumors). Future Directions: Mild TH likely targets multiple mechanisms, contributing to otoprotection, including slowed metabolics, reduced oxidative stress, and involvement of cold shock proteins. Further work is needed to identify the mechanisms of mild TH at play for various forms of acquired hearing loss.
Pre-hospital mild therapeutic hypothermia for patients with severe traumatic brain injury. [2022]We aimed to assess the effects of pre-hospital mild therapeutic hypothermia (MTH) on patients with severe traumatic brain injury (sTBI).
Mild therapeutic hypothermia protects against inflammatory and proapoptotic processes in the rat model of cochlear implant trauma. [2023]Mild therapeutic hypothermia (MTH) has been demonstrated to prevent residual hearing loss from surgical trauma associated with cochlear implant (CI) insertion. Here, we aimed to characterize the mechanisms of MTH-induced hearing preservation in CI in a well-established preclinical rodent model.
Effect of external sleep disturbance on sleep architecture in perimenopausal and postmenopausal women. [2023]This study aimed to use external sleep disturbance as a model to evaluate sleep architecture in climacteric women before and after menopausal hormone therapy (MHT).
Achieving Mild Therapeutic Hypothermia in the Human Cochlea. [2023]To determine temperature and duration of cooling necessary for achieving cochlear mild therapeutic hypothermia (MTH) via ear canal cooling using cool water and earmold attached to a Peltier device.