HyperthermiaNCT07617649
Laboratory Heat Biomarker and Cooling Interventions
A study testing Hand cooling table and Cooling bandana in people with Hyperthermia, run by Stanford University at 1 site in United States.
Trial summary
Our study has two goals. The first goal is to find a blood test that can detect signs of strain from heat in the body ("a biomarker"). Second, the study team wants to identify types of devices that can help people cool down quickly. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthermia
- What is being tested?
- Hand cooling table and Cooling bandana
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50
- Able to communicate in English or Spanish
- General good health
- A lifestyle that includes regular patterns of modest exercise
- Body weight over 80 pounds
Who cannot join
- Cannot provide informed consent
- Known history of cardiac arrhythmias or having a pacemaker
- Difficulty swallowing pills
- Planned upcoming X-ray tests or MRI
- Known history of gastroparesis, diverticulosis or diverticulitis, or inflammatory bowel disease
- Previous surgery on stomach or intestines (except for appendix or gallbladder)
Show all 10Show fewer
- Pregnancy
- Self-reported cardiac, kidney, or pulmonary disease, or diabetes
- Concurrent use of temperature- or inflammation-modulating medications such as steroids or non-steroidal anti-inflammatory drugs (NSAIDs)
- Staff under the direct supervision of any project directors or employed in the laboratory of the study investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University
Stanford, California, 94305
Astrid Elliott, MS, astride@stanford.edu
About this study
Official title: Laboratory Based Identification of Heat Stress Biomarkers and Effective Cooling Interventions
Our study has two goals. The first goal is to find a blood test that can detect signs of strain from heat in the body ("a biomarker"). Second, the study team wants to identify types of devices that can help people cool down quickly.
By identifying biomarkers for heat strain, scientists can better track and treat the health effects of heat. The study team will identify such biomarkers by simulating, in a laboratory-based environment, the heat and physical work that real-world workers experience.
In addition, the study team plans to test two cooling technologies that might keep people cool during physical activity.
- Conditions
- Hyperthermia
- Being tested
- Hand cooling table, Cooling bandana
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand cooling tableOther
A participant can rest their hand on the cooling table after the one hour exercise session, and this should cool their body quickly. Cold water is pumped throughout the cooling table.
Cooling bandanaOther
A participant will tie a bandana that has been soaked in cold water onto their forehead. They will wear this bandana during the one hour exercise session.
| Study group | Role | What they receive |
|---|---|---|
| Biomarker testing (A), Cooling bandana (B), Hand cooling table (C) | Experimental | On day 1 participants use the treadmill for one hour at a research laboratory while being monitored by trained research personnel and no cooling intervention is given to the participants. On day 2, participants use a cooling bandana during exercise for 1 hour. On day 3, participants use a hand cooling table after exercise for 10 minutes during a recovery period. Receives: Other: Hand cooling table; Other: Cooling bandana |
| Biomarker testing (A), Hand cooling table (C), Cooling bandana (B) | Experimental | On day 1 participants use the treadmill for one hour at a research laboratory while being monitored by trained research personnel and no cooling intervention is given to the participants. On day 2, participants use a hand cooling table after exercise for 10 minutes during a recovery period. On day 3, participants use a cooling bandana during exercise for 1 hour. Receives: Other: Hand cooling table; Other: Cooling bandana |
| Cooling bandana (B), Biomarker testing (A), Hand cooling table (C) | Experimental | On day 1, participants use a cooling bandana during exercise for 1 hour at a research laboratory while being monitored by trained research personnel. On day 2 participants use the treadmill for one hour and no cooling intervention is given to the participants. On day 3, participants use a hand cooling table after exercise for 10 minutes during a recovery period. Receives: Other: Hand cooling table; Other: Cooling bandana |
| Cooling bandana (B), Hand cooling table (C), Biomarker testing (A) | Experimental | On day 1, participants use a cooling bandana during exercise for 1 hour at a research laboratory while being monitored by trained research personnel. On day 2, participants use a hand cooling table after exercise for 10 minutes during a recovery period. On day 3 participants use the treadmill for one hour and no cooling intervention is given to the participants. Receives: Other: Hand cooling table; Other: Cooling bandana |
| Hand cooling table (C), Biomarker testing (A), Cooling bandana (B) | Experimental | On day 1, participants use a hand cooling table after exercise for 10 minutes during a recovery period at a research laboratory while being monitored by trained research personnel. On day 2 participants use the treadmill for one hour and no cooling intervention is given to the participants. On day 3, participants use a cooling bandana during exercise for 1 hour. Receives: Other: Hand cooling table; Other: Cooling bandana |
| Hand cooling table (C), Cooling bandana (B), Biomarker testing (A) | Experimental | On day 1, participants use a hand cooling table after exercise for 10 minutes during a recovery period at a research laboratory while being monitored by trained research personnel. On day 2, participants use a cooling bandana during exercise for 1 hour. On day 3 participants use the treadmill for one hour and no cooling intervention is given to the participants. Receives: Other: Hand cooling table; Other: Cooling bandana |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core body temperature
Measured: Baseline through end of study (approximately 2 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for HyperthermiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Parsonnet, Stanford University
- Investigators
- Julie Parsonnet, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617649
- Sponsor's protocol ID
- 86182
- Other IDs
- 1R01DK146310-01
- Status last verified
- May 2026
- First submitted
- 23 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ray SC, Mason J, O'Connor PM. Ischemic Renal Injury: Can Renal Anatomy and Associated Vascular Congestion Explain Why the Medulla and Not the Cortex Is Where the Trouble Starts? Semin Nephrol. 2019 Nov;39(6):520-529. doi: 10.1016/j.semnephrol.2019.10.002.
PubMed 31836035Evans RG, Smith DW, Lee CJ, Ngo JP, Gardiner BS. What Makes the Kidney Susceptible to Hypoxia? Anat Rec (Hoboken). 2020 Oct;303(10):2544-2552. doi: 10.1002/ar.24260. Epub 2019 Sep 30.
PubMed 31566903Febbraio MA. Alterations in energy metabolism during exercise and heat stress. Sports Med. 2001;31(1):47-59. doi: 10.2165/00007256-200131010-00004.
PubMed 11219501Hymczak H, Golab A, Mendrala K, Plicner D, Darocha T, Podsiadlo P, Hudziak D, Gocol R, Kosinski S. Core Temperature Measurement-Principles of Correct Measurement, Problems, and Complications. Int J Environ Res Public Health. 2021 Oct 10;18(20):10606. doi: 10.3390/ijerph182010606.
PubMed 34682351Mazloumi A, Golbabaei F, Mahmood Khani S, Kazemi Z, Hosseini M, Abbasinia M, Farhang Dehghan S. Evaluating Effects of Heat Stress on Cognitive Function among Workers in a Hot Industry. Health Promot Perspect. 2014 Dec 30;4(2):240-6. doi: 10.5681/hpp.2014.031. eCollection 2014.
PubMed 25649311Yin B, Fang W, Liu L, Guo Y, Ma X, Di Q. Effect of extreme high temperature on cognitive function at different time scales: A national difference-in-differences analysis. Ecotoxicol Environ Saf. 2024 Apr 15;275:116238. doi: 10.1016/j.ecoenv.2024.116238. Epub 2024 Mar 21.
PubMed 38518609Alahmad B, Kessler W, Alwadi Y, Schwartz J, Wagner GR, Michaels D. A nationwide analysis of heat and workplace injuries in the United States. Environ Health. 2025 Oct 6;24(1):65. doi: 10.1186/s12940-025-01231-1.
PubMed 41047384McTavish RK, Richard L, McArthur E, Shariff SZ, Acedillo R, Parikh CR, Wald R, Wilk P, Garg AX. Association Between High Environmental Heat and Risk of Acute Kidney Injury Among Older Adults in a Northern Climate: A Matched Case-Control Study. Am J Kidney Dis. 2018 Feb;71(2):200-208. doi: 10.1053/j.ajkd.2017.07.011. Epub 2017 Oct 23.
PubMed 29074166Moyce S, Armitage T, Mitchell D, Schenker M. Acute kidney injury and workload in a sample of California agricultural workers. Am J Ind Med. 2020 Mar;63(3):258-268. doi: 10.1002/ajim.23076. Epub 2019 Nov 26.
PubMed 31773783Grahn DA, Murray JV, Heller HC. Cooling via one hand improves physical performance in heat-sensitive individuals with multiple sclerosis: a preliminary study. BMC Neurol. 2008 May 12;8:14. doi: 10.1186/1471-2377-8-14.
PubMed 18474113Grahn DA, Cao VH, Heller HC. Heat extraction through the palm of one hand improves aerobic exercise endurance in a hot environment. J Appl Physiol (1985). 2005 Sep;99(3):972-8. doi: 10.1152/japplphysiol.00093.2005. Epub 2005 May 5.
PubMed 15879169Lissoway JB, Lipman GS, Grahn DA, Cao VH, Shaheen M, Phan S, Weiss EA, Heller HC. Novel application of chemical cold packs for treatment of exercise-induced hyperthermia: a randomized controlled trial. Wilderness Environ Med. 2015 Jun;26(2):173-9. doi: 10.1016/j.wem.2014.11.006. Epub 2015 Mar 12.
PubMed 25771030Grahn DA, Cao VH, Nguyen CM, Liu MT, Heller HC. Work volume and strength training responses to resistive exercise improve with periodic heat extraction from the palm. J Strength Cond Res. 2012 Sep;26(9):2558-69. doi: 10.1519/JSC.0b013e31823f8c1a.
PubMed 22076097Grahn D, Makam M, Craig Heller H. A method to reduce heat strain while clad in encapsulating outerwear. J Occup Environ Hyg. 2018 Aug;15(8):573-579. doi: 10.1080/15459624.2018.1470635.
PubMed 29708853Kellogg RA, Dunn J, Snyder MP. Personal Omics for Precision Health. Circ Res. 2018 Apr 27;122(9):1169-1171. doi: 10.1161/CIRCRESAHA.117.310909.
PubMed 29700064
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laboratory Based Identification of Heat Stress Biomarkers and Effective Cooling Interventions
- ClinicalTrials.gov ID
- NCT07617649
- Acronym / sponsor ID
- 86182
- Conditions
- Hyperthermia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 1 Jun 2026 (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.
Our study has two goals. The first goal is to find a blood test that can detect signs of strain from heat in the body ("a biomarker"). Second, the study team wants to identify types of devices that can help people cool down quickly.
By identifying biomarkers for heat strain, scientists can better track and treat the health effects of heat. The study team will identify such biomarkers by simulating, in a laboratory-based environment, the heat and physical work that real-world workers experience.
In addition, the study team plans to test two cooling technologies that might keep people cool during physical activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Biomarker testing (A), Cooling bandana (B), Hand cooling table (C) | Experimental | Other: Hand cooling table, Other: Cooling bandanaOn day 1 participants use the treadmill for one hour at a research laboratory while being monitored by trained research personnel and no cooling intervention is given to the participants. On day 2, participants use a cooling bandana during exercise for 1 hour. On day 3, participants use a hand cooling table after exercise for 10 minutes during a recovery period. |
| Biomarker testing (A), Hand cooling table (C), Cooling bandana (B) | Experimental | Other: Hand cooling table, Other: Cooling bandanaOn day 1 participants use the treadmill for one hour at a research laboratory while being monitored by trained research personnel and no cooling intervention is given to the participants. On day 2, participants use a hand cooling table after exercise for 10 minutes during a recovery period. On day 3, participants use a cooling bandana during exercise for 1 hour. |
| Cooling bandana (B), Biomarker testing (A), Hand cooling table (C) | Experimental | Other: Hand cooling table, Other: Cooling bandanaOn day 1, participants use a cooling bandana during exercise for 1 hour at a research laboratory while being monitored by trained research personnel. On day 2 participants use the treadmill for one hour and no cooling intervention is given to the participants. On day 3, participants use a hand cooling table after exercise for 10 minutes during a recovery period. |
| Cooling bandana (B), Hand cooling table (C), Biomarker testing (A) | Experimental | Other: Hand cooling table, Other: Cooling bandanaOn day 1, participants use a cooling bandana during exercise for 1 hour at a research laboratory while being monitored by trained research personnel. On day 2, participants use a hand cooling table after exercise for 10 minutes during a recovery period. On day 3 participants use the treadmill for one hour and no cooling intervention is given to the participants. |
| Hand cooling table (C), Biomarker testing (A), Cooling bandana (B) | Experimental | Other: Hand cooling table, Other: Cooling bandanaOn day 1, participants use a hand cooling table after exercise for 10 minutes during a recovery period at a research laboratory while being monitored by trained research personnel. On day 2 participants use the treadmill for one hour and no cooling intervention is given to the participants. On day 3, participants use a cooling bandana during exercise for 1 hour. |
| Hand cooling table (C), Cooling bandana (B), Biomarker testing (A) | Experimental | Other: Hand cooling table, Other: Cooling bandanaOn day 1, participants use a hand cooling table after exercise for 10 minutes during a recovery period at a research laboratory while being monitored by trained research personnel. On day 2, participants use a cooling bandana during exercise for 1 hour. On day 3 participants use the treadmill for one hour and no cooling intervention is given to the participants. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-50
- Able to communicate in English or Spanish
- General good health
- A lifestyle that includes regular patterns of modest exercise
- Body weight over 80 pounds
Key exclusion criteria (10 listed)
- Cannot provide informed consent
- Known history of cardiac arrhythmias or having a pacemaker
- Difficulty swallowing pills
- Planned upcoming X-ray tests or MRI
- Known history of gastroparesis, diverticulosis or diverticulitis, or inflammatory bowel disease
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 |
|---|---|---|
| Hand cooling tableA participant can rest their hand on the cooling table after the one hour exercise session, and this should cool their body quickly. Cold water is pumped throughout the cooling table. | Other | Biomarker testing (A), Cooling bandana (B), Hand cooling table (C), Biomarker testing (A), Hand cooling table (C), Cooling bandana (B), Cooling bandana (B), Biomarker testing (A), Hand cooling table (C), Cooling bandana (B), Hand cooling table (C), Biomarker testing (A), Hand cooling table (C), Biomarker testing (A), Cooling bandana (B), Hand cooling table (C), Cooling bandana (B), Biomarker testing (A) |
| Cooling bandanaA participant will tie a bandana that has been soaked in cold water onto their forehead. They will wear this bandana during the one hour exercise session. | Other | Biomarker testing (A), Cooling bandana (B), Hand cooling table (C), Biomarker testing (A), Hand cooling table (C), Cooling bandana (B), Cooling bandana (B), Biomarker testing (A), Hand cooling table (C), Cooling bandana (B), Hand cooling table (C), Biomarker testing (A), Hand cooling table (C), Biomarker testing (A), Cooling bandana (B), Hand cooling table (C), Cooling bandana (B), Biomarker testing (A) |
Primary outcome
Core body temperature
Time frame: Baseline through end of study (approximately 2 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 31836035Ray SC, Mason J, O'Connor PM. Ischemic Renal Injury: Can Renal Anatomy and Associated Vascular Congestion Explain Why the Medulla and Not the Cortex Is Where the Trouble Starts? Semin Nephrol. 2019 Nov;39(6):520-529. doi: 10.1016/j.semnephrol.2019.10.002.
- Background: PubMed 31566903Evans RG, Smith DW, Lee CJ, Ngo JP, Gardiner BS. What Makes the Kidney Susceptible to Hypoxia? Anat Rec (Hoboken). 2020 Oct;303(10):2544-2552. doi: 10.1002/ar.24260. Epub 2019 Sep 30.
- Background: PubMed 11219501Febbraio MA. Alterations in energy metabolism during exercise and heat stress. Sports Med. 2001;31(1):47-59. doi: 10.2165/00007256-200131010-00004.
- Background: PubMed 34682351Hymczak H, Golab A, Mendrala K, Plicner D, Darocha T, Podsiadlo P, Hudziak D, Gocol R, Kosinski S. Core Temperature Measurement-Principles of Correct Measurement, Problems, and Complications. Int J Environ Res Public Health. 2021 Oct 10;18(20):10606. doi: 10.3390/ijerph182010606.
- Background: PubMed 25649311Mazloumi A, Golbabaei F, Mahmood Khani S, Kazemi Z, Hosseini M, Abbasinia M, Farhang Dehghan S. Evaluating Effects of Heat Stress on Cognitive Function among Workers in a Hot Industry. Health Promot Perspect. 2014 Dec 30;4(2):240-6. doi: 10.5681/hpp.2014.031. eCollection 2014.
- Background: PubMed 38518609Yin B, Fang W, Liu L, Guo Y, Ma X, Di Q. Effect of extreme high temperature on cognitive function at different time scales: A national difference-in-differences analysis. Ecotoxicol Environ Saf. 2024 Apr 15;275:116238. doi: 10.1016/j.ecoenv.2024.116238. Epub 2024 Mar 21.
- Background: PubMed 41047384Alahmad B, Kessler W, Alwadi Y, Schwartz J, Wagner GR, Michaels D. A nationwide analysis of heat and workplace injuries in the United States. Environ Health. 2025 Oct 6;24(1):65. doi: 10.1186/s12940-025-01231-1.
- Background: PubMed 29074166McTavish RK, Richard L, McArthur E, Shariff SZ, Acedillo R, Parikh CR, Wald R, Wilk P, Garg AX. Association Between High Environmental Heat and Risk of Acute Kidney Injury Among Older Adults in a Northern Climate: A Matched Case-Control Study. Am J Kidney Dis. 2018 Feb;71(2):200-208. doi: 10.1053/j.ajkd.2017.07.011. Epub 2017 Oct 23.
- Background: PubMed 31773783Moyce S, Armitage T, Mitchell D, Schenker M. Acute kidney injury and workload in a sample of California agricultural workers. Am J Ind Med. 2020 Mar;63(3):258-268. doi: 10.1002/ajim.23076. Epub 2019 Nov 26.
- Background: PubMed 18474113Grahn DA, Murray JV, Heller HC. Cooling via one hand improves physical performance in heat-sensitive individuals with multiple sclerosis: a preliminary study. BMC Neurol. 2008 May 12;8:14. doi: 10.1186/1471-2377-8-14.
- Background: PubMed 15879169Grahn DA, Cao VH, Heller HC. Heat extraction through the palm of one hand improves aerobic exercise endurance in a hot environment. J Appl Physiol (1985). 2005 Sep;99(3):972-8. doi: 10.1152/japplphysiol.00093.2005. Epub 2005 May 5.
- Background: PubMed 25771030Lissoway JB, Lipman GS, Grahn DA, Cao VH, Shaheen M, Phan S, Weiss EA, Heller HC. Novel application of chemical cold packs for treatment of exercise-induced hyperthermia: a randomized controlled trial. Wilderness Environ Med. 2015 Jun;26(2):173-9. doi: 10.1016/j.wem.2014.11.006. Epub 2015 Mar 12.
- Individual participant dataSharing planned: No
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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.
Julie Parsonnet, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand cooling table and Cooling bandana in people with Hyperthermia, run by Stanford University 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 1 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core body temperature (time frame: Baseline through end of study (approximately 2 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07617649, which also lists 18 linked publications.
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 1 Jun 2026.