ClinicalTrials.Veeva

Menu

Validity of Humidity Ramp Protocols for Identifying Limits of Survivability in Heat-exposed Persons

University of Ottawa logo

University of Ottawa

Status

Completed

Conditions

Heat Exposure
Temperature; Extreme, Exposure
Temperature Change, Body
Heat Stress

Treatments

Other: Control fixed-condition exposure
Other: Humidity-ramp protocol
Other: Below-inflection fixed-condition exposure
Other: Above-inflection fixed-condition exposure

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male or female adults.
  • Aged 18-85 years.
  • Non-smoking.
  • English or French speaking.
  • Ability to provide informed consent.

Exclusion criteria

  • 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 design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

12 participants in 4 patient groups

Humidity-ramp protocol
Other group
Description:
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.
Treatment:
Other: Humidity-ramp protocol
Above-inflection fixed-condition exposure
Experimental group
Description:
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.
Treatment:
Other: Above-inflection fixed-condition exposure
Below-inflection fixed-condition exposure
Experimental group
Description:
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.
Treatment:
Other: Below-inflection fixed-condition exposure
Control fixed-condition exposure
Active Comparator group
Description:
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.
Treatment:
Other: Control fixed-condition exposure

Trial contacts and locations

1

Loading...

Central trial contact

Robert D Meade, PhD, MPH; Glen P Kenny, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems