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NCT Number: NCT07361588

Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers

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.

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Key information

Conditions

Targeted Temperature Management

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location contact

Neeraj Badjatia, MD, MS

CONTACT

[email protected]

410.328.4515

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

Treatment and study plan

Targeted Temperature Management Intranasal Cooling System

Device

VCool Intranasal Cooling System

Primary outcomes

  1. lower core body temperature

    Time frame: 1 hour

    To confirm the VCool System can lower core body temperature to 35.5℃.

  2. maintain a core body temperature

    Time frame: 1 hour

    To confirm the VCool System can maintain a core body temperature between 35℃ and 36℃ for one hour after cooling.

  3. differential between core body and brain temperature

    Time frame: 2 hours

    To evaluate the differential between core body and brain temperature while using VCool.

Secondary outcomes

  1. Bedside Shivering Assessment Scale (BSAS).

    Time frame: 2 hours

    To assess the shivering experienced by participants based on the 4-point Bedside Shivering Assessment Scale (BSAS).

Study contacts

Contact information is provided by the study sponsor or research team.

Bryan Wand, MEng

CONTACT

[email protected]

443-822-9482

Sponsors and collaborators

Lead sponsor

NeuroIntact Inc.

Industry

Collaborators

  • United States Department of Defense
  • University of Maryland, Baltimore

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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