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Identifying the Limits of Survivability in Heat-exposed Older Females

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07032493
Enrollment
12
Registered
2025-06-24
Start date
2025-07-16
Completion date
2026-05-01
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Heat Exposure, Heat Stress, Temperature Change, Body, Thermoregulation

Keywords

heat strain, women, heat illness, Environmental limits for compensability, heat wave, hot weather, extreme heat events

Brief 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. 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. 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.

Interventions

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.

OTHERAbove-inflection fixed-condition exposure (5%)

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.

OTHERBelow-inflection fixed-condition exposure (5%)

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.

OTHERBelow-inflection fixed-condition exposure (10%)

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.

Participants are exposed for 9-hours to 28°C with 35% relative humidity. Participant will be allowed to drink tap water ad libitum.

Sponsors

University of Ottawa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
65 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Rectal temperature rate of changeEnd of fixed-condition heat exposure (hour 9 or termination)Rate of change of rectal temperature measured over the final 2-hours of heat exposure

Secondary

MeasureTime frameDescription
Number of participants unable to finish fixed-condition heat exposureEnd of fixed-condition heat exposure (hour 9 or termination)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
Mean skin temperature rate of changeEnd of fixed-condition heat exposure (hour 9 or termination)Rate of change of skin temperature measured over the final 2-hours of heat exposure
Core temperature (AUC)End of fixed-condition heat exposure (hour 9 or termination)Area under the curve (AUC) of rectal temperature (in degree-hours) measured over the fixed-condition heat exposure
Predicted time until 40.2°C esophageal temperatureEnd of fixed-condition heat exposure (hour 9 or termination)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)
Heart rate rate of changeEnd of fixed-condition heat exposure (hour 9 or termination)Rate of change of heart rate measured over the final 2-hours of heat exposure
Heart rate (AUC)End of fixed-condition heat exposure (hour 9 or termination)Area under the curve (AUC) of heart rate measured over the fixed-condition heat exposure
Thermal sensationEnd of fixed-condition heat exposure (hour 9 or termination)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).
Thermal comfortEnd of fixed-condition heat exposure (hour 9 or termination)Thermal comfort assessed via a visual analog scale ranging from extremely uncomfortable to extremely comfortable (midpoint: neutral).
Sweat rateEnd of fixed-condition heat exposure (hour 9 or termination)Sweat rate at the end of the fixed-condition exposures (calculated via change in body weight)
Net fluid lossEnd of fixed-condition heat exposure (hour 9 or termination)Net fluid loss estimated as the percentage change in body mass over the fixed-condition exposures.
Profiles of Mood States (POMS)Prior to (hour 0) and at the end of fixed-condition heat exposure (hour 9 or termination)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.
Environmental Symptoms Questionnaire (ESQ)Prior to (hour 0) and at the end of fixed-condition heat exposure (hour 9 or termination)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").

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORGlen P Kenny, PhD

University of Ottawa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026