Clinical trials: Hypothermia, Induced
Cochlear Implants, Cochlear Implantation
Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are: 1.
- Conditions
- Cochlear Implants, Cochlear Implantation, Hearing Loss
- Trial name
- NCT06375278
- Testing
- Intra-Ear Canal Cooling Catheter
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Restorear Devices LLC
Anesthesia Induced Hypothermia, Inadvertent Perioperative Hypothermia
Study to Evaluate Safety and Efficacy of Blanket Used to Prevent Anesthesia Induced Hypothermia
The investigation was designed as an Open-Label, Multicenter, Randomised, Controlled Investigation to Evaluate the Efficacy and Safety of the BARRIER® EasyWarm Active Self-Warming Blanket Used for Continuous Active Warming to…
- Trial name
- NCT01900067
- Testing
- BARRIER® EasyWarm Active Self-Warming Blanket
- Volunteers
- 271 people
- Sponsor
- Molnlycke Health Care AB
Targeted Temperature Management
Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers
The objective of this study is to evaluate the performance and safety of the VCool Intranasal Cooling System in healthy adult volunteers.
- Trial name
- NCT07361588
- Testing
- Targeted Temperature Management Intranasal Cooling System
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- NeuroIntact Inc.
Cellular Injury and Post-Cryogenic Recovery, Cryogenic Cellular Stress
Evaluation of In-Vitro Cryo Therapeutic Protocols on Human Cell Samples (TWH-CRYO-001)
This laboratory-based study evaluates the effects of controlled cryogenic preservation on human cell samples using Truway Health's in-vitro cryo therapeutic methodology.
- Conditions
- Cellular Injury and Post-Cryogenic Recovery, Cryogenic Cellular Stress, Cold-Induced Cellular Injury, Thermal Injury Response
- Trial name
- CRYO-IVT (NCT07321028)
- Testing
- Standard Laboratory Cryopreservation Procedure, Enhanced Laboratory Cryopreservation Procedure, Normothermic Cell Culture Control
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Truway Health, Inc.
Skin Health
Evaluatation of a Microcurrent + Cold Therapy Device
The present study aims to assess use of a microcurrent and cryotherapy device on skin health over an 8-week period using an at-home device that provides 15-minutes of microcurrent + cold therapy once daily.
- Trial name
- NCT07510581
- Testing
- Acute Microcurrent Treatment, Acute Microcurrent + cold therapy, 8-week Chronic Use of Microcurrent + Cold Therapy
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Therabody, Inc.
Tinnitus, Tinnitus, Subjective
External Therapy 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: 1.
- Trial name
- NCT07017998
- Testing
- Cold pack-delivered mild therapeutic hypothermia
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Restorear Devices LLC
Cardiac Arrest
Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients in Japan
A multicenter, single-arm, prospective, interventional trial to evaluate therapeutic hypothermia with intravascular temperature management (IVTM) in post-cardiogenic cardiac arrest, post-return of spontaneous circulation (ROSC)…
- Trial name
- NCT01847482
- Testing
- ZOLL Intravascular Temperature Management System (IVTM)
- Where
- 10 sites in Japan
- Volunteers
- 26 people
- Sponsor
- ZOLL Circulation, Inc., USA
Cardiac Arrest
Induction of Mild Hypothermia in Resuscitated Cardiac Arrest Patients
The primary objectives of this study are to determine the safety and feasibility of inducing mild hypothermia using a non-invasive thermoregulatory device, the Medivance Arctic Sun Temperature Management System, in patients…
- Trial name
- NCT00282373
- Testing
- mild hypothermia
- Where
- 6 sites in United States
- Volunteers
- 64 people
- Sponsor
- Medivance, Inc.
Cardiac Arrest
Phase 1 Study of HBN-1
Phase 1 First-in Human randomized, open-label, active control standard of care study of the safety of HBN-1 administered as pharmacologically induced hypothermia as an adjunct to standard of care targeted temperature management…
- Trial name
- NCT04094857
- Testing
- HBN-1
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Hibernaid, Inc
Severe Hypoxic Ischemic Encephalopathy, Moderate Hypoxic Ischemic Encephalopathy
Efficacy Study of Hypothermia Plus Magnesium Sulphate(MgSO4) in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy
The purpose of this study is to assess whether the addition of a drug such as Magnesium sulphate while providing therapeutic hypothermia (or cooling) to babies who are asphyxiated at birth provides additional benefit to the…
- Trial name
- MagCool (NCT01646619)
- Testing
- Magnesium Sulphate
- Where
- 7 sites in Egypt, Malaysia and 4 more
- Volunteers
- 300 people
- Sponsor
- Sajjad Rahman
Acute Myocardial Infarction
COOL AMI EU Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction
COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute Myocardial Infarction.
- Trial name
- NCT02509832
- Testing
- Cooling + PCI, PCI only
- Where
- 13 sites in Austria, Estonia and 6 more
- Volunteers
- 100 people
- Sponsor
- ZOLL Circulation, Inc., USA
Hypoxic-Ischemic Encephalopathy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant…
- Trial name
- STAR (NCT05778188)
- Testing
- RLS-0071
- Where
- 15 sites in United States
- Volunteers
- 70 people
- Sponsor
- ReAlta Life Sciences, Inc.
Underdosing of Other General Anesthetics
Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex
The primary efficacy endpoint is the time from the start of administration of sugammadex to recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic count) induced by rocuronium during mild…
- Trial name
- NCT01965067
- Testing
- sugammadex
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- MSD Korea Ltd.
Ischemic Stroke
REperfusion With Cooling in CerebraL Acute IscheMia II
The primary objective of this study is to determine the feasibility and safety of achieving rapid hypothermia with the Proteus Intravascular Temperature Management (IVTM) system for patients experiencing acute ischemic stroke due…
- Trial name
- RECCLAIM-II (NCT03804060)
- Testing
- Thermogard XP3, Recanalization only
- Where
- 8 sites in United States
- Volunteers
- 90 people
- Sponsor
- ZOLL Circulation, Inc., USA
Fever, Ischemic Stroke
Impact of Fever Prevention in Brain Injured Patients
This study will assess the impact of fever prevention on fever burden and short- and long-term neurologic outcomes in brain injured patients.
- Conditions
- Fever, Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage
- Trial name
- INTREPID (NCT02996266)
- Testing
- Targeted Temperature Management, Standard Care
- Where
- 40 sites in United States, Australia and 4 more
- Volunteers
- 686 people
- Sponsor
- C. R. Bard
Hypothermia.
CAERvest® - A Novel Endothermic Hypothermic Device for Core Body Cooling. Safety and Efficacy Testing.
Cooling the whole body to 32-34 degrees Centigrade from the normal of around 37 degrees Centigrade for 24 hours has been shown to be an effective way of reducing damage to brain function after return of spontaneous circulation…
- Trial name
- NCT02030236
- Testing
- Cooling
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bodychillz Ltd
Acute Myocardial Infarction
COOL-AMI EU Case Series Clinical Study
A single-center, prospective case series clinical study consecutively enrolling up to 10 patients with expected duration of 12 months or less.
- Trial name
- NCT02070913
- Where
- 23 sites in Czechia, Estonia and 6 more
- Volunteers
- 352 people
- Sponsor
- ZOLL Circulation, Inc., USA
Noise Exposure, Noise-induced Hearing Loss
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
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.
- Conditions
- Noise Exposure, Noise-induced Hearing Loss, Noise; Adverse Effect, Mild Therapeutic Hypothermia
- Trial name
- NCT06729632
- Testing
- Cold pack-delivered mild therapeutic hypothermia
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Restorear Devices LLC
Traumatic Brain Injury
Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device
The aim of this prospective, interventional study is to assess the feasibility and safety of the Esophageal Cooling Device in patients from suffering from traumatic brain injury who the treating physician is treating with…
- Trial name
- NCT02420639
- Testing
- Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.
- Where
- Ukraine
- Volunteers
- 12 people
- Sponsor
- Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Cardiac Arrest
Esophageal Temperature Management After Cardiac Arrest
To control patient's body temperature remains of major importance especially after cardiac arrest (CA). Therapeutic hypothermia (TH) targeted to 32-34°C is now recommended for most unconscious CA patients.
- Trial name
- THE-COOL (NCT02327871)
- Testing
- Esophageal cooling device (and usual standard procedure)
- Where
- France
- Volunteers
- 15 people
- Sponsor
- IST cardiology