- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06842953
Influence of Indoor Humidity on Physiological Strain in Older Adults During a Simulated Heat Wave
Is an Adjustment in the Recommended Indoor Temperature Upper Limit of 26°C Required During Higher Levels of Humidity?
Laboratory-based studies show that exposure to high humidity can worsen the effects of heat stress in young and older adults by impeding sweat evaporation - the main mechanism by which the human body cools itself. At high levels of humidity, the efficiency of sweating decreases causing a greater rise core temperature and burden on the cardiovascular system. In this context, increasing temperatures and humidity with climate change thus pose a potential compound risk for human health. While humidity's role in heat-health outcomes could substantially alter projections of health burdens from climate change, the impact of humidity on physiological strain in vulnerable people in relation to the indoor environment has yet to be evaluated. In a recent study delineating the physiological effects of the proposed 26°C indoor upper limit (PMID: 38329752), relative humidity was set to 45% in all conditions based on indoor humidity standards by the American Society of Heating and Air-Conditioning Engineers. However, it is unknown whether a refinement of the recommended indoor temperature limit of 26°C is required in situations where humidity cannot be maintained at this level.
On separate occasions, the investigators will assess the change in body temperature and cardiovascular strain in older adults (65-85 years) exposed for 10 hours at the recommended indoor temperature limit of 26°C and 45% relative humidity (equivalent humidex of 29 (considered comfortable)) (experimental condition A), to 26°C with a relative humidity of 15% (equivalent humidex of 23 (considered comfortable); humidex is used to measure the perceived temperature taking into account the humidity)) (experimental condition B), to 26°C with a relative humidity of 85% (equivalent humidex of 37 (considered somewhat uncomfortable)) (experimental condition C), and to 31°C and 45% relative humidity with an equivalent humidex of 37 (considered somewhat uncomfortable) that is similar to experimental condition C. With this experimental design, investigators will assess the effects of indoor humidity in driving human heat strain and identify whether refinements in the recommended 26°C indoor temperature limit may be required. Further, by evaluating changes in relation to ambient conditions with a similar humidex, the investigators can assess how individuals perceive and respond to both heat and humidity.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Glen P Kenny, PhD
- Phone Number: 4282 6135625800
- Email: gkenny@uottawa.ca
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1N6N5
- Recruiting
- University of Ottawa
-
Contact:
- Glen P Kenny, PhD
- Phone Number: 4282 6135625800
- Email: gkenny@uottawa.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exposure to recommended indoor temperature limit with normal indoor humidity
Participants exposed daylong (10 hours) to an indoor temperature maintained at 26°C and 45% relative humidity (humidex equivalent of 29).
|
Older adults are exposed to a 10-hour simulated exposure
|
|
Experimental: Exposure to recommended indoor temperature limit with low indoor humidity
Participants exposed daylong (10 hours) to an indoor temperature maintained at 26°C and 15% relative humidity (humidex equivalent of 23).
|
Older adults are exposed to a 10-hour simulated exposure
|
|
Experimental: Exposure to recommended indoor temperature limit with high indoor humidity
Participants exposed daylong (10 hours) to an indoor temperature maintained at 26°C and 85% relative humidity (humidex equivalent of 37).
|
Older adults are exposed to a 10-hour simulated exposure
|
|
Experimental: Exposure to high indoor temperature with normal indoor humidity
Participants exposed daylong (10 hours) to an indoor temperature maintained at 31°C and 45% relative humidity (humidex equivalent of 37).
|
Older adults are exposed to a 10-hour simulated exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Core temperature (Peak) during daylong exposure to indoor overheating
Time Frame: End of 10 hour daylong exposure
|
Peak rectal temperature (15 min average) during exposure.
Rectal temperature is measured continuously throughout the 10 hours of the simulated indoor overheating.
|
End of 10 hour daylong exposure
|
|
Core temperature (AUC) during daylong exposure to indoor overheating
Time Frame: End of 10 hour daylong exposure
|
Areas under the curve (AUC) of rectal temperature during the 10 hour simulate indoor overheating.
|
End of 10 hour daylong exposure
|
|
Heat rate (Peak) during daylong exposure to indoor overheating
Time Frame: End of 10 hour daylong exposure
|
Peak heart rate (15 min average) during exposure.
Heart rate is measured continuously throughout the 10 hours of the simulated indoor overheating.
|
End of 10 hour daylong exposure
|
|
Heart rate (AUC) during daylong exposure to indoor overheating
Time Frame: End of 10 hour daylong exposure
|
Areas under the curve (AUC) of heart rate during the 10 hour simulate indoor overheating.
|
End of 10 hour daylong exposure
|
|
Cardiac response to standing from supine (30:15 Ratio) during daylong exposure to indoor overheating
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
Cardiac response to standing evaluated as the ratio between the highest R-wave to R-wave interval (lowest heart rate) measured at the 30th heart beat after standing from supine (+/- 5 beats) and the lowest R-wave to R-wave interval (highest heart rate) measured at the 15th heart beat after standing (+/- 5 beats).
Cardiac response to standing will be evaluated twice, during two lying-to-standing tests (separated by 10 min of supine rest).
|
At the start (hour 0) and end of 10 hour daylong exposure
|
|
Systolic Response to Standing From Supine during daylong exposure to indoor overheating
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
Systolic blood pressure response to standing evaluated as the difference in blood pressure measured between the standing and supine.
Standing systolic blood pressure will be taken as the lowest value of those measured after 60 and 120 seconds of standing.
Systolic response to standing will be evaluated twice, during two lying-to-standing tests (separated by 10 min of supine rest).
|
At the start (hour 0) and end of 10 hour daylong exposure
|
|
Heart rate variability: RMSSD during daylong exposure to indoor overheating
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
Root mean squared standard deviation of normal-to-normal R-wave to R-wave intervals (RMSSD) measured during 5 minutes of paced breathing (15 breaths/min) with participants in the supine position.
RMSSD will be evaluated twice, during two paced breathing periods (separated by 4 min of supine rest).
|
At the start (hour 0) and end of 10 hour daylong exposure
|
|
Heart rate variability: SDNN during daylong exposure to indoor overheating
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
Standard deviation of normal-to-normal R-wave to R-wave intervals (SDNN) measured during 5 minutes of paced breathing (15 breaths/min) with participants in the supine position.
SDNN will be evaluated twice, during two paced breathing periods (separated by 4 min of supine rest).
|
At the start (hour 0) and end of 10 hour daylong exposure
|
|
Thermal comfort scale during daylong exposure to indoor overheating
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
Thermal comfort assessed via a visual analog scale ranging from extremely uncomfortable to extremely comfortable (midpoint: neutral).
|
At the start (hour 0) and end of 10 hour daylong exposure
|
|
Thirst sensation scale during daylong exposure to indoor overheating
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
Thermal sensation assessed via a visual analog scale ranging from extremely hot to neutral (midpoint: hot).
|
At the start (hour 0) and end of 10 hour daylong exposure
|
|
Arousal scale during daylong exposure to indoor overheating
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
Felt arousal scale assessed via a visual analog scale ("How worked up are you?")
ranging from "high arousal" to "low arousal".
|
At the start (hour 0) and end of 10 hour daylong exposure
|
|
Fluid loss during daylong exposure to indoor overheating
Time Frame: At end of 10 hour daylong exposure
|
Average hourly fluid consumption calculated by weighing participant water intake at the start and end of each hour of exposure (normalized to the exposure duration).
|
At end of 10 hour daylong exposure
|
|
Changes in plasma volume during daylong exposure to indoor overheating
Time Frame: At end of 10 hour daylong exposur
|
Change in plasma volume from baseline values calculated from duplicate measurements of hemoglobin and hematocrit at the start and end of each exposure using the technique by Dill and Costill
|
At end of 10 hour daylong exposur
|
|
Systolic blood pressure during daylong exposure to indoor overheating
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
Systolic blood pressure measured in triplicate via automated oscillometry (~60 seconds between measures)
|
At the start (hour 0) and end of 10 hour daylong exposure
|
|
Rate pressure product during daylong exposure to indoor overheating
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
Rate pressure product, an index of myocardial work and strain, calculated as systolic blood pressure x heart rate.
|
At the start (hour 0) and end of 10 hour daylong exposure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impulse control (cognitive function) during daylong exposure to indoor overheating
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
Participants will be provided with a tablet device with the Sway Medical testing platform for the assessment of impulse control.
Participants will be asked to respond to both "go" and "no-go" visual cues.
In response to the "go" cue, participants will initiate a movement of the device.
|
At the start (hour 0) and end of 10 hour daylong exposure
|
|
Memory recall (cognitive function) during daylong exposure to indoor overheating
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
Participants will be provided with a tablet device with the Sway Medical testing platform for the assessment of memory recall.
Participants complete both a delayed recall test and a working memory test.
|
At the start (hour 0) and end of 10 hour daylong exposure
|
|
CDC 4-Stage Balance Test (Postural stability) during daylong exposure to indoor overheating
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
To assess postural stability, participants hold a tablet to their chest, then auditory cues guide participants through four consecutive stances, feet side by side, instep of one foot touching the big toe of the other foot, tandem stand with one foot in front of the other, heel touching toe, and stand on one foot.
The balance assessment will be evaluated based on movement detected by an accelerometer integrated into the hardware of the tablet device (Sway Medical Inc).
|
At the start (hour 0) and end of 10 hour daylong exposure
|
|
BTrackS Balance Assessment (Postural stability) during daylong exposure to indoor overheating
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
To assess postural stability, participants will be asked to stand on a BTracks force plate with their feet spread out to shoulder width, hand on their hips and eyes closed.
The assessment will comprise of four trials (one practice trial) lasting 20 seconds in length and 20 seconds between trials.
Center of pressure (COP) vector data along vertical (y) and horizontal (x) axes will be summed for the total path excursion length (cm) during each trial.
|
At the start (hour 0) and end of 10 hour daylong exposure
|
|
Profiles of Mood States (POMS) during daylong exposure to indoor overheating
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
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.
|
At the start (hour 0) and end of 10 hour daylong exposure
|
|
Environmental Symptoms Questionnaire (ESQ) during daylong exposure to indoor overheating
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
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").
|
At the start (hour 0) and end of 10 hour daylong exposure
|
|
Sleepiness during daylong exposure to indoor overheating A
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
Karolinska sleepiness scale measures the subjective level of sleepiness at a particular time
|
At the start (hour 0) and end of 10 hour daylong exposure
|
|
Sleepiness during daylong exposure to indoor overheating B
Time Frame: At the start (hour 0) and end of 10 hour daylong exposure
|
Stanford sleepiness scale consists of only one item, where participant must identify one of seven statements that best represents their level of perceived sleepiness.
It employs a scale of 1 to 7 with 1 = feeling wide awake and 7 = sleep onset soon
|
At the start (hour 0) and end of 10 hour daylong exposure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEPRU-2025-02-A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physiological Stress
-
Northumbria UniversityVolac International LtdCompletedStress | Mood | Physiological StressUnited Kingdom
-
University of Texas Southwestern Medical CenterCompletedPhysiological StressUnited States
-
University of UtahActive, not recruiting
-
Massachusetts General HospitalNational Aeronautics and Space Administration (NASA)CompletedPhysiological StressFrance
-
Ohio State UniversityCompletedStress, PhysiologicalUnited States
-
Pennington Biomedical Research CenterCompleted
-
University of Wisconsin, MadisonCompleted
-
Centre Hospitalier Universitaire de NiceTerminatedStress, Physiological
-
Texas State UniversityTexas State University, San MarcosCompleted
-
Texas State UniversityM. Hunter Martaindale; C. Dillard; D. GonzalezCompleted
Clinical Trials on Simulated indoor overheating
-
University of OttawaCompletedPhysiological Stress | Heat StressCanada
-
University of OttawaRecruitingCognitive Change | Physiological Stress | Heat StressCanada
-
University of OttawaRecruitingCognitive Change | Physiological Stress | Heat StressCanada
-
University of OttawaRecruitingCognitive Change | Physiological Stress | Heat StressCanada
-
University of OttawaRecruitingPhysiological Stress | Heat StressCanada
-
Azienda Usl di BolognaCompletedLightning Strategies on Health | Circadian Rhythms Photoentrainment | Photoentrainment and Sleep | DLMOItaly
-
London School of Hygiene and Tropical MedicineMedical Research Council; University of Witwatersrand, South Africa; National... and other collaboratorsCompleted
-
Klein Buendel, Inc.National Cancer Institute (NCI); University of Connecticut; Colorado State University and other collaboratorsCompleted
-
Centre for Evidence-Based Practice, BelgiumBelgian Red CrossCompleted
-
The University of Hong KongRecruitingCannabis Dependence | Cannabis Abuse | Cannabis Use DisorderHong Kong