Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07361588

Enrollment

Registered

2026-01-23

Start date

2026-01-01

Completion date

2026-06-01

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Targeted Temperature Management

Keywords

targeted temperature management

Brief 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.

Interventions

DEVICETargeted Temperature Management Intranasal Cooling System

VCool Intranasal Cooling System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Male or female ages 18 to 55. 2. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities. 3. Baseline core body temperature between 36.8℃ and 37.5℃. 4. Have the ability to understand the requirements of the study and are willing to comply with all study procedures. 5. In the opinion of the Investigator, are able to participate in the study.

Exclusion criteria

1. History of cardiovascular, respiratory, or metabolic disorder 2. Any contraindication to undergoing Magnetic Resonance Imaging (MRI) 3. Pregnant 4. Severe peripheral vascular disease 5. History of Raynaud's disease 6. Currently experiencing a respiratory infection 7. Chronic rhinosinusitis 8. History of sickle cell disease 9. History of cold agglutinin disease 10. History of cryoglobulinemia 11. Known deviated septum or nasal deformity 12. History of nosebleeds or a nosebleed within past 24 hours 13. Use of antipyretics or other medications affecting body temperature within the past 24 hours.

Design outcomes

Primary

Measure	Time frame	Description
lower core body temperature	1 hour	To confirm the VCool System can lower core body temperature to 35.5℃.
maintain a core body temperature	1 hour	To confirm the VCool System can maintain a core body temperature between 35℃ and 36℃ for one hour after cooling.
differential between core body and brain temperature	2 hours	To evaluate the differential between core body and brain temperature while using VCool.

Secondary

Measure	Time frame	Description
Bedside Shivering Assessment Scale (BSAS).	2 hours	To assess the shivering experienced by participants based on the 4-point Bedside Shivering Assessment Scale (BSAS).

Countries

United States

Contacts

CONTACTBryan Wand, MEng

bwand@neurointact.com443-822-9482

STUDY_CHAIRNeeraj Badjatia, MD, MS

University of Maryland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026