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Heat StressNCT07032493

Identifying the Limits of Survivability in Heat-exposed Older Females

A study testing Humidity-Ramp Protocol, Above-inflection fixed-condition exposure (5%) and Below-inflection fixed-condition exposure (5%) in people with Heat Stress and Temperature Change, Body, run by University of Ottawa at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Climate change increases extreme heat events, elevating global heat-illness risk. Females have reduced heat loss capacity (~5%) compared to males, driven by differences in skin blood flow and sweating responses. Read more about this study

Who is it for?
Ages 65 to 85 years, women onlyHealthy volunteers can take part
Conditions the study is for
Heat Stress, Temperature Change, Body, Aging
What is being tested?
Humidity-Ramp Protocol, Above-inflection fixed-condition exposure (5%) and Below-inflection fixed-condition exposure (5%)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesCanada
Study dates
16 Jul 2025to 1 May 2026
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 65 to 85 years
  • Women only
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Non-smoking.
  • English or French speaking.
  • Ability to provide informed consent.
  • With or without a) chronic hypertension (elevated resting blood pressure; as defined by Heart and Stroke Canada and Hypertension Canada), b) type 2 diabetes as defined by Diabetes Canada, with at least 5 years having elapsed since time of diagnosis

Who cannot join

  • Episode(s) of severe hypoglycemia (requiring the assistance of another person) within the previous year, or inability to sense hypoglycemia (hypoglycemia unawareness).
  • Serious complications related to diabetes (gastroparesis, renal disease, uncontrolled hypertension, severe autonomic neuropathy).
  • Uncontrolled hypertension - BP >150 mmHg systolic or >95 mmHg diastolic in a sitting position.
  • Restrictions in physical activity due to disease (e.g. 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.
  • Cardiac abnormalities identified during screening

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • University of Ottawa

    Ottawa, Ontario, K1N6N5

  • University of Ottawa

    Ottawa, Ontario

Other trials in Canada

About this study

Official title: Identifying the Upper Environmental Limits of Thermal Compensation in Older Human Females Using a Rapid Humidity Ramp Protocol

Climate change increases extreme heat events, elevating global heat-illness risk. Females have reduced heat loss capacity (~5%) compared to males, driven by differences in skin blood flow and sweating responses. While findings on sex-mediated mortality are mixed, some studies suggest older females (≥65 years), face higher heat-related mortality/morbidity risks, evidenced by disproportionate female deaths in the 2021 Western Heat Dome. The effects of extreme uncompensable heat on older females remain understudied.

Heat exposure initially causes net heat gain, raising core/skin temperatures and triggering heat-loss responses. Under compensable heat stress, heat loss balances gain, stabilizing core temperature. Uncompensable heat stress (exceeding maximal dissipation capacity) causes continuous core temperature rise, posing severe health risks. The specific temperature and relative humidity (RH) limits where compensability is lost are critical survival determinants, influenced by age and sex.

Read more

Ramping protocols identify these limits: participants face progressively increasing heat stress (e.g., staged humidity rises) while core temperature is monitored. Core temperature typically stabilizes initially, then exhibits an abrupt rapid increase at an inflection point, operationally defined as the limit of compensability. Despite increasing use, ramping protocol validity for accurately identifying this threshold remains unverified.

This project assesses ramping protocol validity for determining uncompensable conditions in older females and evaluates cumulative thermal and cardiovascular strain, as well as psychological and cognitive responses to both uncompensable and compensable heat. Participants will complete five trials. Trial 1 (Ramping): Rest at 42°C, 28% RH for 70min, then incremental RH increases (3% every 10min) to 70% RH. Individual core temperature (rectal) inflection points are identified from the ramping trial. Trials 2-5 (Fixed Conditions, Randomized): i) ~10% below inflection; ii) ~5% below inflection; iii) ~5% above inflection; iv) Thermo-neutral control (26°C, 45% RH). Comparing the rate of rectal temperature change and cumulative strain during prolonged fixed exposures (especially below vs. above inflection) will validate if the ramping inflection point represents the true limit of compensability for older females.

Being tested
Humidity-Ramp Protocol, Above-inflection fixed-condition exposure (5%), Below-inflection fixed-condition exposure (5%), Below-inflection fixed-condition exposure (10%), Control fixed-condition exposure
Keywords
heat strain, women, heat illness, Environmental limits for compensability, heat wave, hot weather, extreme heat events
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 rectal temperature inflect is subsequently determined.

  • Above-inflection fixed-condition exposure (5%)Other

    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' rectal 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 exposure (5%)Other

    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 rectal 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 exposure (10%)Other

    After a 1 hour equilibrium at 42°C and 28% relative humidity, humidity will be increased 3% every 10 min until it is ~10% lower than the participants' individual rectal 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 groups in NCT07032493
Study groupRoleWhat they receive
Humidity-ramp protocolOtherThe humidity-ramp protocol will necessarily be performed first. The order of the fixed-condition exposures will be randomized.
Receives: Other: Humidity-Ramp Protocol
Below-inflection fixed-condition heat exposure (5%)ExperimentalParticipants 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 (5%)
Control fixed-condition heat exposureActive comparatorParticipants 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
Below-inflection fixed-condition heat exposure (10%)ExperimentalParticipants 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 (10%)
Above-inflection fixed-condition heat exposure (5%)ExperimentalParticipants 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 (5%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

Secondary outcomes (12)
  1. 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)

  2. 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)

  3. Core temperature (AUC)

    Area under the curve (AUC) of rectal temperature (in degree-hours) measured over the fixed-condition heat exposure

    Measured: End of fixed-condition heat exposure (hour 9 or termination)

  4. Predicted time until 40.2°C esophageal temperature

    Estimated time for rectal temperature to reach 40.2°C, a commonly-cited criteria for severe heat-illness (e.g., heat stroke), calculated from the end-exposure rectal temperature and its rate of change (assuming this rate of change is sustained)

    Measured: End of fixed-condition heat exposure (hour 9 or termination)

  5. 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)

  6. Heart rate (AUC)

    Area under the curve (AUC) of heart rate measured over the fixed-condition heat exposure

    Measured: End of fixed-condition heat exposure (hour 9 or termination)

  7. 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)

  8. Thermal comfort

    Thermal comfort assessed via a visual analog scale ranging from extremely uncomfortable to extremely comfortable (midpoint: neutral).

    Measured: End of fixed-condition heat exposure (hour 9 or termination)

  9. 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)

  10. 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)

  11. Profiles of Mood States (POMS)

    Potential changes in mood (7 subscales of mood: tension, anger, depression, fatigue, confusion, vigor and esteem-related affect). The POMS-40 is a validated, self-administered questionnaire that examines seven distinct aspects of mood state across two positive subscales (Esteem-Related Affect, and Vigor) and five negative subscales (Fatigue, Tension, Confusion, Anger, and Depression), which are described across 40 distinct adjectives (reference). For each individual item, participants were asked to describe "how you feel right now" by responding using a 5-point Likert scale (0 = "Not at all", 1 = "A little", 2 = "Moderately", 3 = "Quite a lot", or 4 = "Extremely"). The values of items associated with a specific subscale (e.g., Fatigue) were summed to calculate its score.

    Measured: Prior to (hour 0) and at the end of fixed-condition heat exposure (hour 9 or termination)

  12. Environmental Symptoms Questionnaire (ESQ)

    Self-reported environmental reactions and medical symptomatology associated with prolonged heat exposure. The ESQ-IV is a validated 68-item, self-administered questionnaire that has been used successfully in identifying symptomatology during exposure to a wide variety of environmental conditions, including heat exposure [24, 25]. Participants are asked to assess and described "how you have been feeling today" by responding to each item using a 6-point Likert scale (0 = "Not at all", 1 = "Slight", 2 = "Somewhat", 3 = "Moderate", 4 = "Quite a bit", or 5 = "Extreme"). Total Symptom Score was calculated from this data by taking the sum of the intensity ratings from all 68 individual items using reverse scores for the three positive items from the list ("I Felt Good", "I Felt Alert", and "I Felt Wide Awake").

    Measured: Prior to (hour 0) and at the 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.

  1. First posted24 Jun 2025
  2. Study start16 Jul 2025
  3. Primary completion1 May 2026
  4. Study completion1 May 2026

Resources

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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07032493
Sponsor's protocol ID
HEPRU-2025-05-A
Status last verified
Jun 2026
First submitted
14 Jun 2025
Last updated
11 Jun 2026
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.

Questions about this trial

What is this clinical trial studying?

A study testing Humidity-Ramp Protocol, Above-inflection fixed-condition exposure (5%) and Below-inflection fixed-condition exposure (5%) in people with Heat Stress and Temperature Change, Body, run by University of Ottawa at 2 sites 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 4 inclusion and 6 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 11 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 2 sites 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?

Rectal temperature rate of change (time frame: End of fixed-condition heat exposure (hour 9 or termination)). 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 11 Jun 2026.

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