Heat StressNCT05963529
Validity of Humidity Ramp Protocols for Identifying Limits of Survivability in Heat-exposed Persons
A study testing Humidity-ramp protocol, Above-inflection fixed-condition exposure and Below-inflection fixed-condition exposure in people with Heat Stress and Heat Exposure, run by University of Ottawa at 1 site in Canada.
Trial summary
The global populace is at growing risk of heat-related illness due to climate change and accompanying increases in the intensity and regularity of extremely hot temperatures. In heat-exposed persons, heat gain from the environment and metabolism initially exceeds the rate of heat dissipation from the skin. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat Stress, Heat Exposure, Temperature Change, Body
- What is being tested?
- Humidity-ramp protocol, Above-inflection fixed-condition exposure and Below-inflection fixed-condition exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jul 2023to 24 Sep 2023
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female adults.
- Aged 18-85 years.
- Non-smoking.
- English or French speaking.
- Ability to provide informed consent.
Who cannot join
- Physical restriction (e.g., due to disease: intermittent claudication, renal impairment, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis, etc.).
- Use of or changes in medication judged by the patient or investigators to make participation in this study inadvisable (e.g., medications increasing risk of heat-related illness; beta blockers, anticholinergics, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Validity of a Rapid Humidity Ramp Protocol for Identifying the Upper Environmental Limits of Thermal Compensation in Humans
The global populace is at growing risk of heat-related illness due to climate change and accompanying increases in the intensity and regularity of extremely hot temperatures. In heat-exposed persons, heat gain from the environment and metabolism initially exceeds the rate of heat dissipation from the skin. Heat is stored in the body, causing core and skin temperatures to rise, which in turn triggers autonomically mediated elevations in cutaneous blood flow and sweating to facilitate heat loss. If conditions are compensable, heat loss increases until it balances total heat gain. At this point, the rate of heat storage falls to zero (i.e., heat balance is achieved) and body temperature stabilizes, albeit at a level elevated from thermoneutral conditions. If, however, the maximal achievable rate of heat dissipation is insufficient to offset heat gain, conditions are uncompensable, and prolonged exposure will cause a continual rise in core temperature that can compromise health if left unchecked. The environmental limits of compensability (i.e., the temperatures/humidities above which heat balance can not be maintained) are therefore an important determinant of survival during prolonged heat exposure. Evaluating this limit and how it can be modified (e.g., by behavior or individual factors like age or sex) is an increasingly important and active field of study.
Contemporary evaluations of the environmental limits of compensability utilize "ramping protocols" in which participants are exposed to increasing levels of temperature or humidity (in 5-10 min stages) while core temperature is monitored. It is generally observed that core temperature is relatively stable (or rises slightly) in the early stages of exposure but undergoes an abrupt and rapid increase as heat stress becomes more severe. The conditions (e.g., wet-bulb temperature or wet-bulb globe temperature) at this "inflection point" are taken as the limits of compensability. That is, it is assumed that inflection corresponds to the demarcation point, below which core temperature would remain stable for prolonged periods (theoretically indefinitely if hydration is maintained) but above which heat loss is insufficient to offset heat gain, causing core temperature to rise continuously. Despite the increasing use of these protocols, no study has clearly demonstrated their validity for identifying the environmental limits of compensability. The goal of this project is therefore to assess the validity of ramping protocols for determining the ambient conditions above which thermal compensation is not possible.
Enrolled participants will complete four experimental trials in a climate-controlled chamber: one ramping protocol followed by three randomized fixed-condition exposures. In the ramping protocol, participants will rest in 42°C with 28% relative humidity (RH) for 70 min, after which RH will be increased 3% every 10 min until 70% RH is achieved. The core (esophageal) temperature inflection point will be determined. For the fixed-condition exposures, participants will rest in i) 42°C with RH ~5% below their individual inflection point (below-inflection condition), ii) 42°C with RH ~5% above their individual inflection point (above-inflection condition), and iii) 26°C with 45% RH (control condition). Comparing the rate of change in esophageal temperature between each fixed-condition exposure will provide important insight into the validity of ramping protocols for identifying the limits of compensability.
- Being tested
- Humidity-ramp protocol, Above-inflection fixed-condition exposure, Below-inflection fixed-condition exposure, Control fixed-condition exposure
- Keywords
- Heat wave, Hot weather, Heat strain, Cardiovascular strain, Environmental limits for compensability, Extreme heat events, Heat survivability
- Medical subject headings
- Heat Stress Disorders, Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humidity-ramp protocolOther
Participants are exposed to 42°C and 28% relative humidity for 70 minutes. Thereafter, humidity is increased 3% until an ambient humidity of 70% is achieved. The humidity at which esophageal temperature (and rectal temperature and heart rate) inflect is subsequently determined.
Above-inflection fixed-condition exposureOther
After a 1 hour equilibrium at 42°C and 28% relative humidity, humidity will be increased 3% every 10 min until it is ~5% higher than the participants' individual esophageal temperature inflection point identified in the humidity ramp protocol. These conditions will be held constant for the remainder of the 9-hour exposure period (starting from the beginning of equilibrium). Tap water will be provided at regular intervals to limit dehydration.
Below-inflection fixed-condition exposureOther
After a 1 hour equilibrium at 42°C and 28% relative humidity, humidity will be increased 3% every 10 min until it is ~5% lower than the participants' individual esophageal temperature inflection point identified in the humidity ramp protocol. These conditions will be held constant for the remainder of the 9-hour exposure period (starting from the beginning of equilibrium). Tap water will be provided at regular intervals to limit dehydration.
Control fixed-condition exposureOther
Participants are exposed for 9-hours to 28°C with 35% relative humidity. Participant will be allowed to drink tap water ad libitum.
| Study group | Role | What they receive |
|---|---|---|
| Humidity-ramp protocol | Other | Healthy male and female volunteers. Participants will complete all exposures. The humidity-ramp protocol will necessarily be performed first. The order of the fixed-condition exposures will be randomized. Receives: Other: Humidity-ramp protocol |
| Above-inflection fixed-condition exposure | Experimental | Healthy male and female volunteers. Participants will complete all exposures. The humidity-ramp protocol will necessarily be performed first. The order of the fixed-condition exposures will be randomized. Receives: Other: Above-inflection fixed-condition exposure |
| Below-inflection fixed-condition exposure | Experimental | Healthy male and female volunteers. Participants will complete all exposures. The humidity-ramp protocol will necessarily be performed first. The order of the fixed-condition exposures will be randomized. Receives: Other: Below-inflection fixed-condition exposure |
| Control fixed-condition exposure | Active comparator | Healthy male and female volunteers. Participants will complete all exposures. The humidity-ramp protocol will necessarily be performed first. The order of the fixed-condition exposures will be randomized. Receives: Other: Control fixed-condition exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal temperature rate of change
Rate of change of esophageal temperature measured over the final 2-hours of heat exposure
Measured: End of fixed-condition heat exposure (hour 9 or termination)
Predicted time until 40.2°C esophageal temperature
Estimated time for esophageal temperature to reach 40.2°C, a commonly-cited criteria for severe heat-illness (e.g., heat stroke), calculated from the end-exposure esophageal temperature and its rate of change (assuming this rate of change is sustained)
Measured: End of fixed-condition heat exposure (hour 9 or termination)
Rectal temperature rate of change
Rate of change of rectal temperature measured over the final 2-hours of heat exposure
Measured: End of fixed-condition heat exposure (hour 9 or termination)
Predicted time until 40.2°C rectal temperature
Estimated time for rectal temperature to reach 40.2°C, a commonly-cited criteria for
Measured: End of fixed-condition heat exposure (hour 9 or termination)
Secondary outcomes (10)
Number of participants unable to finish fixed-condition heat exposure
Number of participants who could not complete each fixed-condition heat exposure due to participant withdrawal or achieving a core temperature of 39.5°C
Measured: End of fixed-condition heat exposure (hour 9 or termination)
Mean skin temperature rate of change
Rate of change of skin temperature measured over the final 2-hours of heat exposure
Measured: End of fixed-condition heat exposure (hour 9 or termination)
Heart rate rate of change
Rate of change of heart rate measured over the final 2-hours of heat exposure
Measured: End of fixed-condition heat exposure (hour 9 or termination)
Esophageal temperature
Esophageal temperature at the end of the fixed-condition exposures
Measured: End of fixed-condition heat exposure (hour 9 or termination)
Rectal temperature
Rectal temperature at the end of the fixed-condition exposures
Measured: End of fixed-condition heat exposure (hour 9 or termination)
Mean skin temperature
Mean skin temperature at the end of the fixed-condition exposures
Measured: End of fixed-condition heat exposure (hour 9 or termination)
Heart rate
Heart rate at the end of the fixed-condition exposures
Measured: End of fixed-condition heat exposure (hour 9 or termination)
Thermal sensation
Self-reported thermal sensation at the end of the fixed-condition exposures using and 8-point scale ranging from neutral (0) to extremely hot (8).
Measured: End of fixed-condition heat exposure (hour 9 or termination)
Sweat rate
Sweat rate at the end of the fixed-condition exposures (calculated via change in body weight)
Measured: End of fixed-condition heat exposure (hour 9 or termination)
Net fluid loss
Net fluid loss estimated as the percentage change in body mass over the fixed-condition exposures.
Measured: End of fixed-condition heat exposure (hour 9 or termination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start14 Jul 2023
- Primary completion24 Sep 2023
- Study completion24 Sep 2023
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will complete four trial conditions including one humidity-ramp protocol and three fixed-condition exposures. The humidity ramp protocol will always be completed first. Ambient temperature will remain constant at 42°C. After a 1-hour equilibrium period, relative humidity will be increased by 3% in 10-min increments, from 28% to 70%. The inflection point for core (esophageal) temperature will be subsequently determined. On three separate days following the humidity ramp protocol, participants will complete three fixed-condition exposures in random order: 1) 42°C with relative humidity \>5% below the estimate compensability limit (below-threshold condition); 2) 42°C with relative humidity \>5% above the estimated compensability limit (above-threshold condition) and 3) 28°C with 35% relative humidity (control condition). Exposure will be terminated early if core temperature exceeds 39.2°C or if the participant requests to withdraw.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glen P. Kenny, University of Ottawa
- Investigators
- Robert D Meade, PhD, MPH, Study director, University of OttawaGlen P Kenny, PhD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963529
- Sponsor's protocol ID
- uORamp
- Status last verified
- Nov 2023
- First submitted
- 13 Jul 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be made available upon reasonable request and signed access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Validity of a Rapid Humidity Ramp Protocol for Identifying the Upper Environmental Limits of Thermal Compensation in Humans
- ClinicalTrials.gov ID
- NCT05963529
- Acronym / sponsor ID
- uORamp
- Keywords
- Heat wave, Hot weather, Heat strain, Cardiovascular strain, Environmental limits for compensability, Extreme heat events, Heat survivability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 24 Sep 2023 (actual)
- Study completion
- 24 Sep 2023 (actual)
- First posted
- 27 Jul 2023 (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 global populace is at growing risk of heat-related illness due to climate change and accompanying increases in the intensity and regularity of extremely hot temperatures. In heat-exposed persons, heat gain from the environment and metabolism initially exceeds the rate of heat dissipation from the skin. Heat is stored in the body, causing core and skin temperatures to rise, which in turn triggers autonomically mediated elevations in cutaneous blood flow and sweating to facilitate heat loss. If conditions are compensable, heat loss increases until it balances total heat gain. At this point, the rate of heat storage falls to zero (i.e., heat balance is achieved) and body temperature stabilizes, albeit at a level elevated from thermoneutral conditions. If, however, the maximal achievable rate of heat dissipation is insufficient to offset heat gain, conditions are uncompensable, and prolonged exposure will cause a continual rise in core temperature that can compromise health if left unchecked. The environmental limits of compensability (i.e., the temperatures/humidities above which heat balance can not be maintained) are therefore an important determinant of survival during prolonged heat exposure. Evaluating this limit and how it can be modified (e.g., by behavior or individual factors like age or sex) is an increasingly important and active field of study.
Contemporary evaluations of the environmental limits of compensability utilize "ramping protocols" in which participants are exposed to increasing levels of temperature or humidity (in 5-10 min stages) while core temperature is monitored. It is generally observed that core temperature is relatively stable (or rises slightly) in the early stages of exposure but undergoes an abrupt and rapid increase as heat stress becomes more severe. The conditions (e.g., wet-bulb temperature or wet-bulb globe temperature) at this "inflection point" are taken as the limits of compensability. That is, it is assumed that inflection corresponds to the demarcation point, below which core temperature would remain stable for prolonged periods (theoretically indefinitely if hydration is maintained) but above which heat loss is insufficient to offset heat gain, causing core temperature to rise continuously. Despite the increasing use of these protocols, no study has clearly demonstrated their validity for identifying the environmental limits of compensability. The goal of this project is therefore to assess the validity of ramping protocols for determining the ambient conditions above which thermal compensation is not possible.
Enrolled participants will complete four experimental trials in a climate-controlled chamber: one ramping protocol followed by three randomized fixed-condition exposures. In the ramping protocol, participants will rest in 42°C with 28% relative humidity (RH) for 70 min, after which RH will be increased 3% every 10 min until 70% RH is achieved. The core (esophageal) temperature inflection point will be determined. For the fixed-condition exposures, participants will rest in i) 42°C with RH ~5% below their individual inflection point (below-inflection condition), ii) 42°C with RH ~5% above their individual inflection point (above-inflection condition), and iii) 26°C with 45% RH (control condition). Comparing the rate of change in esophageal temperature between each fixed-condition exposure will provide important insight into the validity of ramping protocols for identifying the limits of compensability.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Each participant will complete four trial conditions including one humidity-ramp protocol and three fixed-condition exposures. The humidity ramp protocol will always be completed first. Ambient temperature will remain constant at 42°C. After a 1-hour equilibrium period, relative humidity will be increased by 3% in 10-min increments, from 28% to 70%. The inflection point for core (esophageal) temperature will be subsequently determined. On three separate days following the humidity ramp protocol, participants will complete three fixed-condition exposures in random order: 1) 42°C with relative humidity >5% below the estimate compensability limit (below-threshold condition); 2) 42°C with relative humidity >5% above the estimated compensability limit (above-threshold condition) and 3) 28°C with 35% relative humidity (control condition). Exposure will be terminated early if core temperature exceeds 39.2°C or if the participant requests to withdraw.
| Arm | Type | Receives |
|---|---|---|
| Humidity-ramp protocol | Other | Other: Humidity-ramp protocolHealthy male and female volunteers. Participants will complete all exposures. The humidity-ramp protocol will necessarily be performed first. The order of the fixed-condition exposures will be randomized. |
| Above-inflection fixed-condition exposure | Experimental | Other: Above-inflection fixed-condition exposureHealthy male and female volunteers. Participants will complete all exposures. The humidity-ramp protocol will necessarily be performed first. The order of the fixed-condition exposures will be randomized. |
| Below-inflection fixed-condition exposure | Experimental | Other: Below-inflection fixed-condition exposureHealthy male and female volunteers. Participants will complete all exposures. The humidity-ramp protocol will necessarily be performed first. The order of the fixed-condition exposures will be randomized. |
| Control fixed-condition exposure | Active comparator | Other: Control fixed-condition exposureHealthy male and female volunteers. Participants will complete all exposures. The humidity-ramp protocol will necessarily be performed first. The order of the fixed-condition exposures will be randomized. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female adults.
- Aged 18-85 years.
- Non-smoking.
- English or French speaking.
- Ability to provide informed consent.
Key exclusion criteria (2 listed)
- Physical restriction (e.g., due to disease: intermittent claudication, renal impairment, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis, etc.).
- Use of or changes in medication judged by the patient or investigators to make participation in this study inadvisable (e.g., medications increasing risk of heat-related illness; beta blockers, anticholinergics, 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 |
|---|---|---|
| Humidity-ramp protocolParticipants are exposed to 42°C and 28% relative humidity for 70 minutes. Thereafter, humidity is increased 3% until an ambient humidity of 70% is achieved. The humidity at which esophageal temperature (and rectal temperature and heart rate) inflect is subsequently determined. | Other | Humidity-ramp protocol |
| Above-inflection fixed-condition exposureAfter a 1 hour equilibrium at 42°C and 28% relative humidity, humidity will be increased 3% every 10 min until it is ~5% higher than the participants' individual esophageal temperature inflection point identified in the humidity ramp protocol. These conditions will be held constant for the remainder of the 9-hour exposure period (starting from the beginning of equilibrium). Tap water will be provided at regular intervals to limit dehydration. | Other | Above-inflection fixed-condition exposure |
| Below-inflection fixed-condition exposureAfter a 1 hour equilibrium at 42°C and 28% relative humidity, humidity will be increased 3% every 10 min until it is ~5% lower than the participants' individual esophageal temperature inflection point identified in the humidity ramp protocol. These conditions will be held constant for the remainder of the 9-hour exposure period (starting from the beginning of equilibrium). Tap water will be provided at regular intervals to limit dehydration. | Other | Below-inflection fixed-condition exposure |
| Control fixed-condition exposureParticipants are exposed for 9-hours to 28°C with 35% relative humidity. Participant will be allowed to drink tap water ad libitum. | Other | Control fixed-condition exposure |
Primary outcome
Esophageal temperature rate of change
Time frame: End of fixed-condition heat exposure (hour 9 or termination)
Rate of change of esophageal temperature measured over the final 2-hours of heat exposure
Predicted time until 40.2°C esophageal temperature
Time frame: End of fixed-condition heat exposure (hour 9 or termination)
Estimated time for esophageal temperature to reach 40.2°C, a commonly-cited criteria for severe heat-illness (e.g., heat stroke), calculated from the end-exposure esophageal temperature and its rate of change (assuming this rate of change is sustained)
Rectal temperature rate of change
Time frame: End of fixed-condition heat exposure (hour 9 or termination)
Rate of change of rectal temperature measured over the final 2-hours of heat exposure
Predicted time until 40.2°C rectal temperature
Time frame: End of fixed-condition heat exposure (hour 9 or termination)
Estimated time for rectal temperature to reach 40.2°C, a commonly-cited criteria for
10 secondary outcomes
Number of participants unable to finish fixed-condition heat exposure
Time frame: End of fixed-condition heat exposure (hour 9 or termination)
Mean skin temperature rate of change
Time frame: End of fixed-condition heat exposure (hour 9 or termination)
Heart rate rate of change
Time frame: End of fixed-condition heat exposure (hour 9 or termination)
Esophageal temperature
Time frame: End of fixed-condition heat exposure (hour 9 or termination)
Rectal temperature
Time frame: End of fixed-condition heat exposure (hour 9 or termination)
Mean skin temperature
Time frame: End of fixed-condition heat exposure (hour 9 or termination)
Heart rate
Time frame: End of fixed-condition heat exposure (hour 9 or termination)
Thermal sensation
Time frame: End of fixed-condition heat exposure (hour 9 or termination)
Sweat rate
Time frame: End of fixed-condition heat exposure (hour 9 or termination)
Net fluid loss
Time frame: End of fixed-condition heat exposure (hour 9 or termination)
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 29 Nov 2023.
- Individual participant dataSharing planned: Yes. De-identified participant data will be made available upon reasonable request and signed access agreement.
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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.
Robert D Meade, PhD, MPH study director
University of Ottawa
Glen P Kenny, PhD principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humidity-ramp protocol, Above-inflection fixed-condition exposure and Below-inflection fixed-condition exposure in people with Heat Stress and Heat Exposure, run by University of Ottawa at 1 site in Canada.
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 2 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 29 Nov 2023. 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 Canada. 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?
Esophageal temperature rate of change (time frame: End of fixed-condition heat exposure (hour 9 or termination)). The study lists 4 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 29 Nov 2023.