Not Yet RecruitingNot Applicable

Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers

United States10 participantsStarted 2026-01

Plain-language summary

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.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

lower core body temperature

Timeframe: 1 hour

maintain a core body temperature

Timeframe: 1 hour

differential between core body and brain temperature

Timeframe: 2 hours

Trial details

NCT IDNCT07361588

SponsorNeuroIntact Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Bryan Wand, MEng

443-822-9482 bwand@neurointact.com

View on ClinicalTrials.gov More Targeted Temperature Management trials