Heat StressNCT05302674
Short- and Long-term Health Consequences of Workers During Consecutive Days of Heat Stress
A study testing Hot Dry in people with Heat Stress and Fatigue, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The purpose of this study is to measure fatigue and indicators of acute kidney injury during consecutive days of work in a hot environment. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat Stress, Fatigue
- What is being tested?
- Hot Dry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 14 Mar 2024
- 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
- Healthy individuals
- Regularly completes aerobic exercise at least 60 min per week
Who cannot join
- History of cardiovascular, metabolic, respiratory, neural, or renal disease
- Hypertensive or tachycardic during the screening visit (Systolic Blood Pressure > 139 mmHg, Diastolic Blood Pressure > 89 mmHg, heart rate > 100 bpm)
- Current tobacco or nicotine use or previous regular use within the past 2 years
- Current or previous musculoskeletal injury limiting physical activity
- Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
- A positive pregnancy test at any point during the study or currently breastfeeding
- Study physician discretion based on any other medical condition or medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Research and Education in Special Environments
Buffalo, New York, 14214
About this study
The purpose of this study is to measure fatigue and indicators of acute kidney injury during consecutive days of work in a hot environment.
- Conditions
- Heat Stress, Fatigue
- Being tested
- Hot Dry
- Medical subject headings
- Heat Stress Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot DryOther
98°F (36.7°C) and 20% relative humidity environment
| Study group | Role | What they receive |
|---|---|---|
| Hot Dry | Experimental | The participant will complete four hours of work at a 45:15 work rest cycle in a 98°F (36.7°C) and 20% relative humidity environment. Receives: Other: Hot Dry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in fatigue
Fatigue will be measured using accelerometry, with the primary variable being jerk, the smoothness or unevenness of movement.
Measured: Hour 4
Biomarkers of acute kidney injury
Tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP7) are biomarkers that have the potential for early prediction of acute kidney injury.
Measured: Hour 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Apr 2022
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StressStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- Investigators
- Riana R Pryor, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302674
- Sponsor's protocol ID
- STUDY00005847
- Status last verified
- Jun 2024
- First submitted
- 11 Mar 2022
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to share individual participant data with other researchers. Aggregate results will be shared via publications and/or presentations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short- and Long-term Health Consequences of Workers During Consecutive Days of Heat Stress
- ClinicalTrials.gov ID
- NCT05302674
- Acronym / sponsor ID
- STUDY00005847
- Conditions
- Heat Stress, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 31 Mar 2022 (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 purpose of this study is to measure fatigue and indicators of acute kidney injury during consecutive days of work in a hot environment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hot Dry | Experimental | Other: Hot DryThe participant will complete four hours of work at a 45:15 work rest cycle in a 98°F (36.7°C) and 20% relative humidity environment. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy individuals
- Regularly completes aerobic exercise at least 60 min per week
Key exclusion criteria (7 listed)
- History of cardiovascular, metabolic, respiratory, neural, or renal disease
- Hypertensive or tachycardic during the screening visit (Systolic Blood Pressure > 139 mmHg, Diastolic Blood Pressure > 89 mmHg, heart rate > 100 bpm)
- Current tobacco or nicotine use or previous regular use within the past 2 years
- Current or previous musculoskeletal injury limiting physical activity
- Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
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 |
|---|---|---|
| Hot Dry98°F (36.7°C) and 20% relative humidity environment | Other | Hot Dry |
Primary outcome
Change from baseline in fatigue
Time frame: Hour 4
Fatigue will be measured using accelerometry, with the primary variable being jerk, the smoothness or unevenness of movement.
Biomarkers of acute kidney injury
Time frame: Hour 4
Tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP7) are biomarkers that have the potential for early prediction of acute kidney injury.
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 17 Jun 2024.
- Individual participant dataSharing planned: No. There is not a plan to share individual participant data with other researchers. Aggregate results will be shared via publications and/or presentations.
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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.
Riana R Pryor, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot Dry in people with Heat Stress and Fatigue, 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 2 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 17 Jun 2024. 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?
Change from baseline in fatigue (time frame: Hour 4). The study lists 2 primary outcomes in all. 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 17 Jun 2024.