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Could a nasal device cool your body? early trial begins

NCT ID NCT07361588

Knowledge-focused Sponsor: NeuroIntact Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a device called VCool that is placed in the nose to cool the body. Ten healthy adults aged 18 to 55 will try it to see if it safely lowers core body temperature to about 35.5°C and keeps it there for an hour. The goal is to gather early data on how well it works and any side effects like shivering.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VCool Intranasal Cooling System (device)
What this could lead to
If it works, this could point toward a non-invasive way to cool the body for medical emergencies like stroke or fever.
What could go wrong
This is a very early feasibility study with only 10 healthy volunteers. It may not work as expected or cause discomfort like shivering.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Targeted temperature management

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • R Adams Cowley Shock Trauma Center

    Baltimore, Maryland, 21201, United States

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