An interventional study of Simulated indoor temperature upper limit in Heat Stress and Physiological Stress, sponsored by University of Ottawa. Recruiting at 1 site in Canada. Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by University of Ottawa · Not applicable, Interventional, and Basic science
Among 30 studies in Heat Stress Disorders by University of Ottawa — 13 open to participants now, 13 under way, none of them phase 3. Heat Stress Disorders · University of Ottawa.
Among the 30 studies in Heat Stress Disorders by University of Ottawa, this one is the 24th largest by planned enrollment, is one of 7 that started in 2025, is one of 30 with no phase, reaches primary completion later than 4 of the 12 other live ones, and was the 20th registered.
118 studies on the registry are indexed under Heat Stress Disorders; 45 are open to participants now.
This study's planned enrollment of 10 is below the median of 24 across 104 interventional studies indexed under Heat Stress Disorders.
Browse Heat Stress Disorders studies →13 of the 30 studies in Heat Stress Disorders by University of Ottawa are open now, in 1 country. Each count lists the studies.
Of the 32 Heat Stress Disorders studies recruiting now, 8 (25%) set no upper age limit and 18 (56%) stop at 75 or younger; 7 take children under 18; 23 take healthy volunteers.
This study: 65 Years to 85 Years · all sexes · healthy volunteers too.
The full table on the hub →30 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 7 started in 2025.
Median enrollment 16 across the 30 interventional studies. Of the 16 that completed or were terminated, 0 (0%) have results posted.
University of Ottawa is the lead sponsor of 125 studies on the registry; 34 are open to participants now.
8 of the studies in Heat Stress Disorders by University of Ottawa that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07664462University of OttawaWorking in the Heat at Simulated Altitude: Effects of Normobaric Hypoxia on Physiological Strain | 2026-12-31 |
| NCT07781605University of OttawaAmbient Temperature and Thermoregulation During Exercise in Children and Youth | 2027-04-30 |
| NCT07781592University of OttawaExercise Intensity and Heat Responses in Children and Youth | 2027-04-30 |
| NCT07864103University of OttawaEfficacy of Electric Fans in Children During Heat Waves | 2027-04-30 |
| NCT07852910University of OttawaIndoor Overheating and Physiological Strain in Older Adults With COPD | 2027-05-31 |
Among the 30 studies in Heat Stress Disorders by University of Ottawa, from their registry updates:
While an upper limit of 26°C has been shown to be protective for heat-vulnerable older occupants (DOI: 10.1289/EHP11651), this recommendation did not consider the added heat burden associated with increases in internal heat production accompanying activities of daily living or the restriction to heat loss caused by clothing insulation. To safeguard the health of older adults, health agencies worldwide recommend the remain in cool space indoors, avoid strenuous activity, wear lightweight clothing, and drink cool water regularly throughout the day. However, older adults do not sense heat as well as their younger counterparts. Consequently, they may not take appropriate countermeasures to mitigate physiological strain from indoor overheating. This may include overdressing despite high indoor temperatures. In other cases, individuals may wear insulated clothing in hot weather to observe cultural or religious modesty requirements, which serve as expressions of faith and identity rather than a tool for thermoregulation. Further, individuals may be unaware of the consequences of increases in physical activity on heat gain and may therefore not adjust their normal day-to-day activity levels to prevent potentially dangerous rises in body temperature. Consequently, this may necessitate a lowering of recommended upper indoor temperature limit during hot weather.
To address these important considerations, on separate occasions the investigators will assess the change in body temperature and cardiovascular strain in older adults (65-85 years) exposed for 8 hours to the recommended indoor temperature upper limit of 26°C and 45% relative humidity equivalent humidex of 29 (considered comfortable) while they A) perform seated rest dressed in light clothing (t-shirt, shorts and socks), B) perform light exercise (stepping exercise to simulate activities of daily living, 4-4.5 METS) every hour (except during lunch hour period) dressed in light clothing, C) perform light exercise (4-4.5 METS) every hour (except during lunch hour period) dressed in light clothing (t-shirt, shorts and socks) and an added clothing layer (sweatshirt and sweatpants) and D) perform seated rest dressed in light clothing (t-shirt, shorts and socks) and an added clothing layer (sweatshirt and sweatpants). With this experimental design, investigators will assess the effects of added clothing insulation and light activity, representative in activities of daily living on physiological strain and identify whether refinements in the recommended 26°C indoor temperature limit may be required.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants, dressed in light clothing (t-shirt, shorts and socks), perform seated rest while exposed daylong (8 hours) to an indoor temperature maintained at 26°C and 45% relative humidity (humidex equivalent of 29).
Other: Simulated indoor temperature upper limit
Participants, dressed in light clothing (t-shirt, shorts and socks), perform light exercise (i.e., stepping, representing activities of daily living, 4-4.5 METS) every hour (except during lunch hour period) while exposed daylong (8 hours) to an indoor temperature maintained at 26°C and 45% relative humidity (humidex equivalent of 29).
Other: Simulated indoor temperature upper limit
Participants, dressed in light clothing (t-shirt, shorts and socks) and an added clothing layer (sweatshirt and sweatpants), perform seated rest while exposed daylong (8 hours) to an indoor temperature maintained at 26°C and 45% relative humidity (humidex equivalent of 29).
Other: Simulated indoor temperature upper limit
Participants, dressed in light clothing (t-shirt, shorts and socks) and an added clothing layer (sweat shirt and sweat pants), perform light exercise (i.e., stepping, representing activities of daily living, 4-4.5 METS) every hour (except during lunch hour period) while exposed daylong (8 hours) to an indoor temperature maintained at 26°C and 45% relative humidity (humidex equivalent of 29).
Other: Simulated indoor temperature upper limit
Older adults exposed to an 8-hour simulated exposure.
Core temperature (Peak) during daylong exposure to indoor temperature limit.
Peak rectal temperature (15 min average) during exposure. Rectal temperature is measured continuously throughout the 8 hour exposure to the simulated indoor temperature upper limit.
Time frame: End of 8 hour daylong exposure
Profiles of Mood States (POMS) during daylong exposure to indoor temperature limit.
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. 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.
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Environmental Symptoms Questionnaire (ESQ) during daylong exposure to indoor temperature limit.
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").
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Activity levels during daylong exposure to indoor overheating
Activity levels assessed via a wearable monitor (Actical) containing an accelerometer worn on the wrist and hip.
Time frame: End of 8 hour daylong exposure
Hydration status during daylong exposure to indoor overheating
Hydration status measured via assessing the urine specific gravity of a urine sample.
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Perceived exertion scale during daylong exposure to indoor temperature limit.
Perceived exertional assessed via a visual analog scale ("How hard are you working?") ranging from "no exertional at all" to "maximal exertion"
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Feel good scale during daylong exposure to indoor temperature limit.
Feel good assessed via a visual analog scale ("How good do you feel?") ranging from "very good" to "very bad"(midpoint: neutral)
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Orthostatic intolerance symptoms assessment during daylong exposure to indoor temperature limit.
Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance during the lying to standing tests. All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort".
Time frame: At end of 8 hour daylong exposure.
Thermal sensation 2 scale during daylong exposure to indoor temperature limit.
Thermal sensation assessed via a visual analog scale ("How do you feel?") ranging from "hot" to "cold"(midpoint: neutral)
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Thermal sensation scale during daylong exposure to indoor temperature limit.
Thermal sensation assessed via a visual analog scale ("How hot do you feel?") ranging from "extremely hot" to "neutral"(midpoint: hot)
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Arousal scale during daylong exposure to indoor temperature limit.
Felt arousal scale assessed via a visual analog scale ("How worked up are you?") ranging from "high arousal" to "low arousal".
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Thirst sensation scale during daylong exposure to indoor temperature limit.
Thirst sensation assessed via a visual analog scale ranging from "very, very thirsty" to "not thirsty at all".
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Thermal comfort scale during daylong exposure to indoor temperature limit.
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") ranging from "very uncomfortable" to "comfortable".
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Change in plasma volume during daylong exposure to indoor temperature limit.
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.
Time frame: At end of 8 hour daylong exposure.
Fluid loss during daylong exposure to indoor temperature limit.
Fluid loss calculated as the change in body mass during each exposure presented as a percentage of baseline body mass (corrected for food consumption).
Time frame: At end of 8 hour daylong exposure
Fluid consumption during daylong exposure to indoor temperature limit.
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).
Time frame: At end of 8 hour daylong exposure
BTrackS Balance Assessment during daylong exposure to indoor temperature limit (postural stability).
To assess postural stability, participants will be asked to stand on a BTracks force plate with their feet spread out to shoulder width while looking straight ahead. The assessment will comprise of one trial lasting 120 seconds in length. 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.
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
CDC 4-Stage Balance Test during daylong exposure to indoor temperature limit (postural stability).
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).
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Impulse control during daylong exposure to indoor temperature limit (cognitive function).
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.
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Reaction time during daylong exposure to indoor temperature limit (cognitive function).
Participants will be provided with a tablet device with the Sway Medical testing platform for the assessment of reaction time. Participants will be asked to initiate a movement of the device in response to a visual cue.
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Rate pressure product during daylong exposure to indoor temperature limit.
Rate pressure product, an index of myocardial work and strain, calculated as systolic blood pressure x heart rate.
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Diastolic blood pressure during daylong exposure to indoor temperature limit.
Diastolic blood pressure measured in triplicate via automated oscillometry (\~60 seconds between measures).
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Systolic blood pressure during daylong exposure to indoor temperature limit.
Systolic blood pressure measured in triplicate via automated oscillometry (\~60 seconds between measures).
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Systolic response to standing from supine during daylong exposure to indoor temperature limit.
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).
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Cardiac response to standing from supine (30:15 ratio) during daylong exposure to indoor temperature limit.
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).
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Heart rate variability: SDNN during daylong exposure to indoor temperature limit.
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).
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Heart rate variability: RMSSD during daylong exposure to indoor temperature limit.
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).
Time frame: At the start (hour 0) and end of 8 hour daylong exposure
Heart rate end of daylong exposure to indoor temperature limit.
Heart rate measured at hour 8 of exposure to indoor temperature limit (15-min average).
Time frame: End of 8 hour daylong exposure
Heart rate (AUC) during daylong exposure to indoor temperature limit.
Areas under the curve (AUC) of heart rate during the 8 hour exposure to the simulate indoor temperature upper limit.
Time frame: End of 8 hour daylong exposure
Heat rate (Peak) during daylong exposure to indoor temperature limit.
Peak heart rate (15 min average) during exposure. Heart rate is measured continuously throughout the 8 hour exposure to the simulated indoor temperature upper limit.
Time frame: End of 8 hour daylong exposure
Mean skin temperature end of daylong exposure to indoor temperature limit.
Mean skin temperature measured over 7 body regions at hour 8 of exposure to indoor temperature limit (15-min average).
Time frame: End of 8 hour daylong exposure
Mean skin temperature (AUC) during daylong exposure to indoor temperature limit.
Areas under the curve (AUC) of mean skin temperature as calculated over 7 body regions during the 8 hour exposure to the simulate indoor temperature upper limit.
Time frame: End of 8 hour daylong exposure
Mean skin temperature (Peak) during daylong exposure to indoor temperature limit.
Peak mean skin temperature (15 min average) during exposure. Mean skin temperature as calculated from skin temperature measured across 7 body regions is measured continuously throughout the 8 hour exposure to the simulated indoor temperature upper limit.
Time frame: End of 8 hour daylong exposure
Core temperature end of daylong exposure to indoor temperature limit.
Rectal temperature measured at hour 8 of exposure to indoor temperature limit (15-min average).
Time frame: End of 8 hour daylong exposure
Core temperature (AUC) during daylong exposure to indoor temperature limit.
Areas under the curve (AUC) of rectal temperature during the 8 hour exposure to the simulate indoor temperature upper limit.
Time frame: End of 8 hour daylong exposure
Sleep quality and quantify assessment during daylong exposure to indoor temperature limit.
The Pittsburg Sleep Quality Index will be administered to provide an overview of the sleep quantity and quality of individuals over the previous month.
Time frame: At start of 8 hour daylong exposure.
Started Sep 2025 (actual). Primary completion is estimated for Sep 2026, 12 months after the start.
Of 75 non-industry interventional studies with no phase under Heat Stress Disorders, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 12 months is below that.
Counting every sponsor, half of 75 studies reached it within 16 months; a quarter within 4 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
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