Transnasal Induction of Normothermia for Neurogenic Fever

NCT06038513 | Terminated DMC FDA Device

• 1 other identifier: COT-002
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke, Ischemic; Stroke Hemorrhagic; Seizures; Metabolic Encephalopathy

Keywords

shivering, fever, normothermia, TTM

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (4)

• Temperature burden above 37.5°C (°C*hours) during the 24-hour cooling period

  24 hours

• Incidence of shivering during cooling period

  24 hours

• Number of shivering interventions per patient

  24 hours

• Incidence of adverse events.

  24 hours

Study Arms (1)

Transnasal Thermal Regulating Device

EXPERIMENTAL

Consented subjects who develop fever will undergo cooling via transnasal thermal regulating device for a period of 24 hours

Device: Transnasal Thermal Regulating Device

Interventions

Transnasal Thermal Regulating Device DEVICE

Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 24 hours

Also known as: CoolStat

Transnasal Thermal Regulating Device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• CoolTech LLC: lead
• Maryland Industrial Partnerships: collaborator

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Seizures; Brain Diseases, Metabolic; Fever; Trichotillomania

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Temperature Changes; Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 14, 2023
• Study Start: November 21, 2023
• Primary Completion: August 1, 2025
• Study Completion: November 30, 2025
• Last Updated: January 26, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)