Stroke, IschemicNCT06038513
Transnasal Induction of Normothermia for Neurogenic Fever
A study testing Transnasal Thermal Regulating Device in people with Stroke, Ischemic and Stroke Hemorrhagic, run by CoolTech LLC at 1 site in United States.
Trial summary
The objective of this study is to evaluate the efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Ischemic, Stroke Hemorrhagic, Seizures
- What is being tested?
- Transnasal Thermal Regulating Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2023to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to an Intensive Care Unit for a planned stay of at least 24 hours with a diagnosis of ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.
- Ages 18-85 years, inclusive.
- Patient has fever ≥ 38.3°C and ≤ 38.9°C at the time of treatment initiation.
- Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.
- Glasgow Coma Scale score of 3-11, inclusive.
- Must have informed consent from the patient or the legally authorized representative (LAR) making decisions for the patient.
Who cannot join
- Intubation is contraindicated.
- Weight of ≤ 100lb or ≥ 250lb.
- Active/ongoing epistaxis.
- Known or suspected pregnancy.
- Participation in another ongoing investigational study.
- Prisoners and/or patients for whom no LAR is available.
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- Patient is in airborne/droplet disease isolation protocol.
- Patient is or suspected to be immunocompromised.
- Nasal septal deviations (per standard of care CT scan; any degree).
- Chronic rhinosinusitis.
- Traumatic brain injury.
- Prior skull-base surgery.
- Penetrating cranial trauma.
- Recent nasal trauma or anterior base skull fracture.
- Any condition for which transnasal air flow would be contraindicated.
- Refractory hypoxemia (partial pressure of oxygen in arterial blood (paO2) below 60 torr or oxyhemoglobin saturation below 90% despite endotracheal intubation, mechanical ventilation, and provision of supplemental oxygen of up to 0.60).
- Refractory hypercarbia (partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: A Prospective, Open Label Clinical Trial to Evaluate the Safety and Efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in Inducing Normothermia for Neurogenic Fever in an Intensive Care Setting
The objective of this study is to evaluate the efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.
- Being tested
- Transnasal Thermal Regulating Device
- Keywords
- shivering, fever, normothermia, TTM
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Seizures, Brain Diseases, Metabolic, Fever, Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal Thermal Regulating DeviceDevice
Also called CoolStat
Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Transnasal Thermal Regulating Device | Experimental | Consented subjects who develop fever will undergo cooling via transnasal thermal regulating device for a period of 24 hours Receives: Device: Transnasal Thermal Regulating Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve normothermia (≤37.5°C)
To evaluate the efficacy of the COOLSTAT® in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.
Measured: 24 hours
Secondary outcomes (4)
Temperature burden above 37.5°C (°C*hours) during the 24-hour cooling period
To evaluate the efficacy of the COOLSTAT® in maintaining normothermia over a 24-hour cooling period
Measured: 24 hours
Incidence of shivering during cooling period
To assess the frequency of shivering incidents caused by the CoolStat device.
Measured: 24 hours
Number of shivering interventions per patient
To assess the frequency shivering interventions caused by the CoolStat device.
Measured: 24 hours
Incidence of adverse events.
To evaluate the safety of the CoolStat device.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start21 Nov 2023
- Primary completion1 Aug 2025
- Study completion30 Nov 2025
Why it stopped: Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoolTech LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maryland Industrial Partnerships
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038513
- Sponsor's protocol ID
- COT-002
- Status last verified
- Feb 2025
- First submitted
- 8 Sep 2023
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label Clinical Trial to Evaluate the Safety and Efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in Inducing Normothermia for Neurogenic Fever in an Intensive Care Setting
- ClinicalTrials.gov ID
- NCT06038513
- Acronym / sponsor ID
- COT-002
- Keywords
- shivering, fever, normothermia, TTM
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient accrual
- Enrolment
- 9 participants (actual)
- Lead sponsor
- CoolTech LLCIndustry (pharma, biotech, devices)
- Collaborators
- Maryland Industrial Partnerships
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transnasal Thermal Regulating Device | Experimental | Device: Transnasal Thermal Regulating DeviceConsented subjects who develop fever will undergo cooling via transnasal thermal regulating device for a period of 24 hours |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Admitted to an Intensive Care Unit for a planned stay of at least 24 hours with a diagnosis of ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.
- Ages 18-85 years, inclusive.
- Patient has fever ≥ 38.3°C and ≤ 38.9°C at the time of treatment initiation.
- Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.
- Glasgow Coma Scale score of 3-11, inclusive.
Key exclusion criteria (17 listed)
- Intubation is contraindicated.
- Weight of ≤ 100lb or ≥ 250lb.
- Active/ongoing epistaxis.
- Known or suspected pregnancy.
- Participation in another ongoing investigational study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transnasal Thermal Regulating DeviceAlso: CoolStatPlacement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 24 hours | Device | Transnasal Thermal Regulating Device |
Primary outcome
Time to achieve normothermia (≤37.5°C)
Time frame: 24 hours
To evaluate the efficacy of the COOLSTAT® in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.
4 secondary outcomes
Temperature burden above 37.5°C (°C*hours) during the 24-hour cooling period
Time frame: 24 hours
Incidence of shivering during cooling period
Time frame: 24 hours
Number of shivering interventions per patient
Time frame: 24 hours
Incidence of adverse events.
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transnasal Thermal Regulating Device in people with Stroke, Ischemic and Stroke Hemorrhagic, run by CoolTech LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to achieve normothermia (≤37.5°C) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.