HyperthermiaNCT04613843
Cold Water Immersion Stirring in Hyperthermic Individuals
A study testing Water Stirring and No Water Stirring in people with Hyperthermia, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The best way to cool a very hot person is using cold water immersion, however, the optimization of this technique has not been established. The goal of this study is to determine differences in cooling rates among two types of cold water immersion and passive cooling following immersion. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthermia
- What is being tested?
- Water Stirring and No Water Stirring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2019to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-39 y old men and women
- Self-reported to be healthy
- Currently completes aerobic exercise at least 30 minutes a day, at least 2 days per week
Who cannot join
- History of any cardiovascular, neurologic, renal, or metabolic disease
- History of any contraindications on the CoreTemp contraindications and warnings document
- Current tobacco use or regular use within the last 2 years
- Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
- History of exertional heat stroke
- Currently pregnant or breastfeeding
- Inability to follow the rules of the protocols or understand the consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Research and Exercise in Special Environments
Buffalo, New York, 14214
About this study
The best way to cool a very hot person is using cold water immersion, however, the optimization of this technique has not been established. The goal of this study is to determine differences in cooling rates among two types of cold water immersion and passive cooling following immersion.
- Conditions
- Hyperthermia
- Being tested
- Water Stirring, No Water Stirring
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water StirringOther
Following an active heating protocol, the cooling intervention includes vigorous water stirring throughout cold water immersion.
No Water StirringOther
Following an active heating protocol, the cooling intervention includes no water stirring throughout cold water immersion.
| Study group | Role | What they receive |
|---|---|---|
| Water stirring | Active comparator | Not described Receives: Other: Water Stirring |
| No water stirring | Experimental | Not described Receives: Other: No Water Stirring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cooling rate
The core temperature cooling rate
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start23 Oct 2019
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, counterbalanced, crossover design
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riana Pryor, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613843
- Sponsor's protocol ID
- STUDY00003720
- Status last verified
- Jul 2022
- First submitted
- 30 Oct 2020
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be made available upon written request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Water Immersion Stirring in Hyperthermic Individuals
- ClinicalTrials.gov ID
- NCT04613843
- Acronym / sponsor ID
- STUDY00003720
- Conditions
- Hyperthermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The best way to cool a very hot person is using cold water immersion, however, the optimization of this technique has not been established. The goal of this study is to determine differences in cooling rates among two types of cold water immersion and passive cooling following immersion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, counterbalanced, crossover design
| Arm | Type | Receives |
|---|---|---|
| Water stirring | Active comparator | Other: Water Stirring |
| No water stirring | Experimental | Other: No Water Stirring |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-39 y old men and women
- Self-reported to be healthy
- Currently completes aerobic exercise at least 30 minutes a day, at least 2 days per week
Key exclusion criteria (7 listed)
- History of any cardiovascular, neurologic, renal, or metabolic disease
- History of any contraindications on the CoreTemp contraindications and warnings document
- Current tobacco use or regular use within the last 2 years
- Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
- History of exertional heat stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water StirringFollowing an active heating protocol, the cooling intervention includes vigorous water stirring throughout cold water immersion. | Other | Water stirring |
| No Water StirringFollowing an active heating protocol, the cooling intervention includes no water stirring throughout cold water immersion. | Other | No water stirring |
Primary outcome
Cooling rate
Time frame: 20 minutes
The core temperature cooling rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: No. Individual participant data will be made available upon written request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Stirring and No Water Stirring in people with Hyperthermia, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cooling rate (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.