Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers

Starting soon · Not applicable

Conditions studied: Targeted Temperature Management

In brief

The objective of this study is to evaluate the performance and safety of the VCool Intranasal Cooling System in healthy adult volunteers. The study is designed to gather preliminary data regarding air flow rates and time required to reduce core body temperature to 35.5℃ and maintain the temperature between 35℃ and 36℃ for one hour after cooling.

Key facts

Study ID

NCT07361588

Run by

NeuroIntact Inc.

People needed

10

Starts

2026-01-01

Expected to finish

2026-06-01

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female ages 18 to 55.
• An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
• Baseline core body temperature between 36.8℃ and 37.5℃.
• Have the ability to understand the requirements of the study and are willing to comply with all study procedures.
• In the opinion of the Investigator, are able to participate in the study.

You may not qualify if…

• History of cardiovascular, respiratory, or metabolic disorder
• Any contraindication to undergoing Magnetic Resonance Imaging (MRI)
• Pregnant
• Severe peripheral vascular disease
• History of Raynaud's disease
• Currently experiencing a respiratory infection
• Chronic rhinosinusitis
• History of sickle cell disease
• History of cold agglutinin disease
• History of cryoglobulinemia
• Known deviated septum or nasal deformity
• History of nosebleeds or a nosebleed within past 24 hours
• Use of antipyretics or other medications affecting body temperature within the past 24 hours.

Where it is running

• R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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