HyperthermiaNCT04625634
Simulation of Consecutive Day Shift Work
A study testing 2 days of work heat stress in people with Hyperthermia and Fatigue; Heat, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The purpose of this study is to determine differences in physiological recovery between two consecutive days of simulated fire suppression work. The secondary purpose is to determine differences in heat gain and heat loss between two consecutive days of simulated fire suppression work. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthermia, Fatigue; Heat
- What is being tested?
- 2 days of work heat stress
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 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
Who cannot join
- History of any cardiovascular, neurologic, renal, or metabolic disease
- Current tobacco use or regular use within the last 2 years
- Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.)
- History of exertional heat stroke
- Currently pregnant or breastfeeding, or planning to become pregnant during the study
- Inability to follow the rules of the protocols or understand the consent form
- No contraindications for ingestion of the gastrointestinal temperature pill
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 purpose of this study is to determine differences in physiological recovery between two consecutive days of simulated fire suppression work. The secondary purpose is to determine differences in heat gain and heat loss between two consecutive days of simulated fire suppression work. Subjects will complete two consecutive days of simulated structural firefighting shift work, 24 hours apart. Before and after each laboratory visit, subjects will continuously wear a Holter monitor and ambulatory blood pressure monitor to quantify parasympathetic tone and recovery from work.
- Conditions
- Hyperthermia, Fatigue; Heat
- Being tested
- 2 days of work heat stress
- Medical subject headings
- Hyperthermia, Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 days of work heat stressOther
2 consecutive days of identical simulated structural firefighting tasks.
| Study group | Role | What they receive |
|---|---|---|
| Consecutive work | Experimental | Subjects will complete 2 consecutive days of simulated firefighting tasks in the heat. The simulated work consists of 20 minutes of simulated structural work in a hot environment, followed by 20 minutes of seated rest in a temperate room, mimicking a typical recovery period in structural firefighting. Subjects then re-enter the environmental chamber and complete 23 minutes of simulated overhaul work in a temperate environment. Receives: Other: 2 days of work heat stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature
Gastrointestinal temperature measured with an ingestable pill.
Measured: 20 minutes
Heart rate
Heart rate measured with a wearable heart rate strap and monitor
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 posted12 Nov 2020
- Study start2 Dec 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated measures study
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT04625634
- Sponsor's protocol ID
- STUDY00003948
- Status last verified
- Jul 2022
- First submitted
- 6 Nov 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 data can 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
- Simulation of Consecutive Day Shift Work
- ClinicalTrials.gov ID
- NCT04625634
- Acronym / sponsor ID
- STUDY00003948
- Conditions
- Hyperthermia, Fatigue; Heat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 12 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 purpose of this study is to determine differences in physiological recovery between two consecutive days of simulated fire suppression work. The secondary purpose is to determine differences in heat gain and heat loss between two consecutive days of simulated fire suppression work. Subjects will complete two consecutive days of simulated structural firefighting shift work, 24 hours apart. Before and after each laboratory visit, subjects will continuously wear a Holter monitor and ambulatory blood pressure monitor to quantify parasympathetic tone and recovery from work.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated measures study
| Arm | Type | Receives |
|---|---|---|
| Consecutive work | Experimental | Other: 2 days of work heat stressSubjects will complete 2 consecutive days of simulated firefighting tasks in the heat. The simulated work consists of 20 minutes of simulated structural work in a hot environment, followed by 20 minutes of seated rest in a temperate room, mimicking a typical recovery period in structural firefighting. Subjects then re-enter the environmental chamber and complete 23 minutes of simulated overhaul work in a temperate environment. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-39 y old men and women
- Self-reported to be healthy
Key exclusion criteria (7 listed)
- History of any cardiovascular, neurologic, renal, or metabolic disease
- Current tobacco use or regular use within the last 2 years
- Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.)
- History of exertional heat stroke
- Currently pregnant or breastfeeding, or planning to become pregnant during the study
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 |
|---|---|---|
| 2 days of work heat stress2 consecutive days of identical simulated structural firefighting tasks. | Other | Consecutive work |
Primary outcome
Core temperature
Time frame: 20 minutes
Gastrointestinal temperature measured with an ingestable pill.
Heart rate
Time frame: 20 minutes
Heart rate measured with a wearable heart rate strap and monitor
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 data can 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 2 days of work heat stress in people with Hyperthermia and Fatigue; Heat, 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 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?
Core temperature (time frame: 20 minutes). 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 26 Jul 2022.