Clinical trials: Targeted Temperature Management, open to volunteers
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
Hypoxic-ischemic Encephalopathy (HIE)
The PROTECT-HIE Pilot Trial
Some babies experience a lack of oxygen and blood flow around the time of birth. This can lead to a serious condition called hypoxic-ischemic encephalopathy (HIE), which can injure the brain and other organs, including the heart.
- Trial name
- PROTECT-HIE (NCT07406477)
- Testing
- Dobutamine, TnECHO
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- University of Alberta
Neonatal Encephalopathy, Newborn Asphyxia
Cooling in Mild Encephalopathy
The goal of this randomised control trial is to establish the safety and efficacy of whole-body hypothermia for babies with mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and establish…
- Trial name
- COMET (NCT05889507)
- Testing
- Whole body hypothermia, Targeted normothermia, Supportive neonatal intensive care
- Where
- 39 sites in Italy, United Kingdom
- Volunteers
- 426 people
- Sponsor
- Imperial College London
Newborn Asphyxia
Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy
Therapeutic hypothermia (TH) is the standard of care for newborns with moderate to severe hypoxic-ischaemic encephalopathy (HIE) born at 35 weeks or more of gestation.
- Trial name
- NCT06394453
- Testing
- enteral feeding with mother milk or human donor breast milk
- Where
- Poland
- Volunteers
- 104 people
- Sponsor
- Nutricia Foundation
Elderly Patients, Cancer Surgery
Targeted Temperature Management on Delayed Neurocognitive Recovery in Older Patients After Major Cancer Surgery
With aging population, more older patients will receive major surgery for cancer. Older patients are at increased risk of postoperative neurocognitive complications including delayed neurocognitive recovery (dNCR), which is…
- Conditions
- Elderly Patients, Cancer Surgery, Hypothermia, Accidental, Targeted Temperature Management
- Trial name
- NCT07655687
- Testing
- Target temperature management, Routine thermal management
- Where
- 2 sites in China
- Volunteers
- 1,512 people, healthy volunteers welcome
- Sponsor
- Peking University First Hospital
Encephalopathy, Hypoxic Ischemic
Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia
The goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic…
- Trial name
- NCT05767476
- Testing
- Clinical and instrumental neurological assessment
- Where
- 2 sites in Italy
- Volunteers
- 70 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Stroke, Acute Ischemic Stroke
Head Cooling in Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy (COOLHEAD-2b)
COOLHEAD-2b is a multicentre, phase 2, prospective, randomised, controlled, open-label, blinded-endpoint trial evaluating the safety and efficacy of non-invasive convective head cooling as an adjunct to endovascular thrombectomy…
- Conditions
- Stroke, Acute Ischemic Stroke, Brain Ischemia, Ischaemic Stroke
- Trial name
- COOLHEAD-2B (NCT07526649)
- Testing
- Non-invasive convective head cooling, Standard of Care (SOC)
- Where
- New Zealand
- Volunteers
- 182 people
- Sponsor
- Auckland City Hospital
Periapical Diseases
Evaluation of Post Operative Pain After Using Intracranial Cryotherapy During Single Visit RCT
A total of 60 patients presenting with single-rooted teeth exhibiting symptomatic apical periodontitis were subjected to a randomized allocation into two groups of 30 each.
- Trial name
- NCT07598188
- Testing
- Saline 0.9% (1.5-2.5°C)
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Islamabad Medical and Dental College
Tinnitus, Tinnitus, Subjective
Noninvasive Therapy for Tinnitus
The goal of this interventional clinical study is to establish mild therapeutic hypothermia, delivered non-invasively to the structures of the inner ear, as a safe and repeatable therapeutic method for symptomatic relief of…
- Trial name
- NCT07071480
- Testing
- Cold pack-delivered mild therapeutic hypothermia
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Restorear Devices LLC
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
Total Knee Arthroplasty
Effect of Different Cold Therapy Programs in Patients Received Total Knee Arthroplasty Operation
This study conducts clinical experiments on the form, temperature, frequency and other issues of cooling therapy, so as to provide scientific evidence for the practice of cooling therapy and improve the comfort and effect of…
- Trial name
- NCT07021287
- Testing
- mixed ice and water, continuous ice application, mixed ice and water, intermittent ice compress, full ice, continuous ice compress
- Where
- 2 sites in China
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Traumatic Brain Injury
Therapeutic Normothermia in TBI
This feasibility trial is the first step in testing the hypothesis that maintenance of normal body temperature, called therapeutic normothermia (TN), for 72 continuous hours in traumatic brain injury (TBI) patients can improve…
- Trial name
- MAMBA-FT (NCT06540768)
- Testing
- Therapeutic Normothermia Group
- Volunteers
- 50 people
- Sponsor
- London Health Sciences Centre
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Most patients resuscitated from out-of-hospital cardiac arrest (OHCA) remain comatose on hospital admission and are routinely managed with continuous sedation.
- Conditions
- Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury, Post-Cardiac Arrest Syndrome
- Trial name
- NCT07895771
- Testing
- Minimal sedation, Standard continuous sedation
- Where
- Slovenia
- Volunteers
- 100 people
- Sponsor
- University Medical Centre Ljubljana
Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia
EEG-Based Decision-Support Algorithm for Hypoxic-Ischemic Encephalopathy in Term Newborns
This retrospective, multicenter, observational study evaluates how well a decision-support algorithm can tell apart mild forms of hypoxic-ischemic encephalopathy (HIE) from moderate or severe forms in full-term newborns born…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia, Neonatal Brain Injury
- Trial name
- COOLDECIDE (NCT07764315)
- Volunteers
- 310 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Therapeutic Hypothermia, Neonatal Hypoxic-Ischemic Encephalopathy
Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia
This prospective observational pilot study aims to evaluate the feasibility, accuracy, and safety of the SteadyTemp® wireless adhesive thermometer for continuous, non-invasive body temperature monitoring in neonates undergoing…
- Conditions
- Therapeutic Hypothermia, Neonatal Hypoxic-Ischemic Encephalopathy, Neonatal Thermal Management
- Trial name
- MonT HT (NCT07756892)
- Testing
- continous temperature measurement
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Medical University of Graz
Cancer Surgery, Intraoperative Hypothermia
Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival
Intraoperative hypothermia is common in patients having major surgery and the compliance with intraoperative temperature monitoring and management remains poor.
- Conditions
- Cancer Surgery, Intraoperative Hypothermia, Targeted Temperature Management, Postoperative Delirium
- Trial name
- NCT06256354
- Testing
- Routine thermal management, Target temperature management
- Where
- 36 sites in China
- Volunteers
- 3,992 people
- Sponsor
- Peking University First Hospital
Ischemic Stroke
Targeted Temperature Management in Acute Ischemic Stroke
The goal of this interventional trial is to evaluate whether the CB240_Aurora medical device is effective for targeted temperature management in adult patients with acute ischemic stroke.
- Trial name
- TTM-STROKE (NCT07096687)
- Testing
- Targeted Temperature Management with CB240_Aurora, Standard of care Temperature treatment
- Where
- Italy
- Volunteers
- 22 people
- Sponsor
- Azienda Usl di Bologna
Ischemic Stroke, Large Vessel Occlusion
Combination of Hypothermia and Thrombectomy in Acute Stroke
The goal of this clinical trial is to test the combination of hypothermia and endovascular treatment in acute stroke patients with large vessel occlusion.
- Conditions
- Ischemic Stroke, Large Vessel Occlusion, Endovascular Treatment
- Trial name
- COTTIS-2 (NCT06301412)
- Testing
- hypothermia
- Where
- Germany
- Volunteers
- 400 people
- Sponsor
- University of Freiburg
Hypoxic-ischemic Encephalopathy (HIE)
Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam
This study aims to evaluate the effectiveness of therapeutic hypothermia in neonates diagnosed with hypoxic-ischemic encephalopathy (HIE).
- Trial name
- HIE-TH Vietnam (NCT07555652)
- Testing
- Therapeutic Hypothermia
- Where
- Vietnam
- Volunteers
- 120 people
- Sponsor
- National Children's Hospital, Vietnam