Heat StressNCT07261202
Impact of Indoor Overheating on Physiological Strain in Children
A study testing Simulated exposure to indoor overheating in people with Heat Stress and Physiological Stress, run by University of Ottawa at 1 site in Canada.
Trial summary
Communities worldwide are experiencing increasing heat extremes that challenge the limits of human thermoregulation, particularly among vulnerable populations such as children. Compared with adults, children are more susceptible to heat related illness due to less efficient thermoregulatory systems and difficulty… Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat Stress, Physiological Stress, Cognitive Change
- What is being tested?
- Simulated exposure to indoor overheating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 8 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- English or French speaking.
- Ability to provide informed assent.
Who cannot join
- Chronic health conditions
- Endurance exercise training (greater than 3 sessions of vigorous exercise training per week for 30 minutes or more)
- Restrictions to physical activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa
Ottawa, Ontario, K1N 6N5
Glen P Kenny, PhD, 613-562-5800 ext. 4282, gkenny@uottawa.ca
About this study
Official title: A Preliminary Study Assessing the Effectiveness of a 26 °C Indoor Temperature Limit on Physiological Responses in Children
Communities worldwide are experiencing increasing heat extremes that challenge the limits of human thermoregulation, particularly among vulnerable populations such as children. Compared with adults, children are more susceptible to heat related illness due to less efficient thermoregulatory systems and difficulty recognizing early signs of heat stress. In addition, prolonged heat exposure can adversely affect their mental health, contributing to cognitive decline, heightened anxiety, and irritability. As children spend substantial time in hot environments at school and at home, and as these conditions intensify with climate change, actions to safeguard their health are essential. Yet our understanding of heat exposure effects in children remains incomplete, hindering the development of evidence based strategies to protect them.
To address this gap, the investigators aim to evaluate whether an indoor temperature limit of 26 °C (45 percent relative humidity), the upper threshold recommended to protect older adults, can effectively prevent dangerous increases in physiological strain and declines in cognitive function in children during a simulated daylong heatwave. The preliminary study will assess physiological and cognitive responses in children aged 10 to 15 years during a 6 hour exposure (approximating a typical school day) to two conditions: (1) the recommended indoor temperature upper limit (26 °C) and (2) a high heat condition representative of homes and schools without air conditioning during extreme heat events (36 °C). In both conditions, children will remain seated at rest while wearing light clothing (t shirt and shorts), with the exception of performing 15 minutes of stepping exercise (6-6.5 METS) each hour (excluding the lunch period) to reflect typical daily activity in a school setting. This experimental design will allow investigators to determine whether maintaining indoor temperatures at the recommended upper limit for older adults sufficiently mitigates physiological strain in children.
- Conditions
- Heat Stress, Physiological Stress, Cognitive Change
- Being tested
- Simulated exposure to indoor overheating
- Keywords
- Indoor overheating, Indoor temperatures, Heat wave, Thermoregulation, Adolescent, Heat strain, Heat vulnerability, Hyperthermia, Youth, Thermal comfort, Physical activity
- Medical subject headings
- Heat Stress Disorders, Hyperthermia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated exposure to indoor overheatingOther
Children exposed to a 6-hour simulated heat exposure
| Study group | Role | What they receive |
|---|---|---|
| Exposure to indoor temperature upper limit of 26°C | Experimental | Participants exposed daylong (6 hours) to an indoor temperature maintained at 26°C and 45% relative humidity (humidex equivalent of 29). Receives: Other: Simulated exposure to indoor overheating |
| Exposure to hot indoor environment of 36°C | Experimental | Participants exposed daylong (6 hours) to an indoor temperature maintained at 36°C and 45% relative humidity (humidex equivalent of 45). Receives: Other: Simulated exposure to indoor overheating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature (Peak) during daylong exposure to indoor overheating
Peak visceral temperature (15 min average) during exposure. Visceral temperature is measured continuously throughout the 6 hour exposure to the simulated indoor overheating.
Measured: End of 6 hour daylong exposure
Secondary outcomes (28)
Profiles of Mood States (POMS) during daylong exposure to indoor overheating
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.
Measured: At the start (hour 0) and end of 6 hour daylong exposure
Environmental Symptoms Questionnaire (ESQ) during daylong exposure to indoor overheating
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.
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: At the start (hour 0) and end of 6 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"
Measured: At the start (hour 0) and end of 6 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.
Measured: End of 6 hour daylong exposure
Feel good scale during daylong exposure to indoor overheating
Feel good scale assessed via a visual analog scale (How good do you feel?) ranging from "very good" to "very bad" (midpoint: neutral)
Measured: At the start (hour 0) and end of 6 hour daylong exposure
Thirst sensation scale during daylong exposure to indoor overheating
Thirst sensation assessed via a visual analog scale ranging from very, very thirsty to not thirsty at all.
Measured: At the start (hour 0) and end of 6 hour daylong exposure
Thermal comfort scale during daylong exposure to indoor overheating
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") ranging from "very uncomfortable" to "comfortable".
Measured: At the start (hour 0) and end of 6 hour daylong exposure
Thermal sensation 2 scale during daylong exposure to indoor overheating
Thermal sensation assessed via a visual analog scale ("How do you feel?") ranging from "hot" to "cold"(midpoint: neutral)
Measured: At the start (hour 0) and end of 6 hour daylong exposure
Thermal sensation scale during daylong exposure to indoor overheating
Thermal sensation assessed via a visual analog scale (How hot do you feel?) ranging from "extremely hot" to "neutral".
Measured: At the start (hour 0) and end of 6 hour daylong exposure
Fluid loss during daylong exposure to indoor overheating
Fluid loss calculated as the change in body mass during each exposure presented as a percentage of baseline body mass (corrected for food consumption).
Measured: At end of 6 hour daylong exposure
Fluid consumption during daylong exposure to indoor overheating
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).
Measured: At end of 6 hour daylong exposure
Hydration status during daylong exposure to indoor overheating
Hydration status measured via assessing the urine specific gravity of a urine sample.
Measured: At the start (hour 0) and end of 6 hour daylong exposure
BTrackS Balance Assessment during daylong exposure to indoor overheating (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, 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
Measured: At the start (hour 0) and end of 6 hour daylong exposure
Executive function during daylong exposure to indoor overheating (cognitive function).
Participants will be provided with a tablet device with the Sway Medical testing platform for the assessment of executive function. Participants will complete the Cued Stroop test, in which they are presented a sequence of congruent, neutral and incongruent color-word tasks.
Measured: At the start (hour 0) and end of 6 hour daylong exposure
CDC 4-Stage Balance Test during daylong exposure to indoor overheating (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).
Measured: At the start (hour 0) and end of 6 hour daylong exposure
Memory recall during daylong exposure to indoor overheating (cognitive function).
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.
Measured: At the start (hour 0) and end of 6 hour daylong exposure
Impulse control during daylong exposure to indoor overheating (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.
Measured: At the start (hour 0) and end of 6 hour daylong exposure
Reaction time during daylong exposure to indoor overheating (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.
Measured: At the start (hour 0) and end of 6 hour daylong exposure
Diastolic blood pressure during daylong exposure to indoor overheating.
Diastolic blood pressure measured in triplicate via automated oscillometry (~60 seconds between measures).
Measured: At the start (hour 0) and end of 6 hour daylong exposure
Systolic blood pressure during daylong exposure to indoor overheating
Systolic blood pressure measured in triplicate via automated oscillometry (~60 seconds between measures).
Measured: At the start (hour 0) and end of 6 hour daylong exposure
Heart rate end of daylong exposure to indoor overheating
Heart rate measured at hour 6 of exposure to indoor overheating (15-min average).
Measured: End of 6 hour daylong exposure
Heart rate (AUC) during daylong exposure to indoor overheating
Areas under the curve (AUC) of heart rate during the 6 hour exposure to the simulate indoor overheating.
Measured: End of 6 hour daylong exposure
Heat rate (Peak) during daylong exposure to indoor overheating
Peak heart rate (15 min average) during exposure. Heart rate is measured continuously throughout the 6 hour exposure to the simulated indoor overheating.
Measured: End of 6 hour daylong exposure
Mean skin temperature end of daylong exposure to indoor overheating
Mean skin temperature measured over 7 body regions at hour 6 of exposure to indoor overheating (15-min average).
Measured: End of 6 hour daylong exposure
Mean skin temperature (AUC) during daylong exposure to indoor overheating
Areas under the curve (AUC) of mean skin temperature as calculated over 7 body regions during the 6 hour exposure to the simulate indoor overheating.
Measured: End of 6 hour daylong exposure
Mean skin temperature (Peak) during daylong exposure to indoor overheating
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 6 hour exposure to the simulated indoor overheating.
Measured: End of 6 hour daylong exposure
Core temperature end of daylong exposure to indoor overheating
Visceral temperature measured at hour 6 of exposure to indoor overheating (15-min average).
Measured: End of 6 hour daylong exposure
Core temperature (AUC) during daylong exposure to indoor overheating
Areas under the curve (AUC) of visceral temperature during the 6 hour exposure to the simulate indoor overheating.
Measured: End of 6 hour daylong exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start8 Nov 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glen P. Kenny, University of Ottawa
- Investigators
- Glen P Kenny, PhD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261202
- Sponsor's protocol ID
- HEPRU-2025-10-A
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study Assessing the Effectiveness of a 26 °C Indoor Temperature Limit on Physiological Responses in Children
- ClinicalTrials.gov ID
- NCT07261202
- Acronym / sponsor ID
- HEPRU-2025-10-A
- Conditions
- Heat Stress, Physiological Stress, Cognitive Change
- Keywords
- Indoor overheating, Indoor temperatures, Heat wave, Thermoregulation, Adolescent, Heat strain, Heat vulnerability, Hyperthermia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- 8 Nov 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Communities worldwide are experiencing increasing heat extremes that challenge the limits of human thermoregulation, particularly among vulnerable populations such as children. Compared with adults, children are more susceptible to heat related illness due to less efficient thermoregulatory systems and difficulty recognizing early signs of heat stress. In addition, prolonged heat exposure can adversely affect their mental health, contributing to cognitive decline, heightened anxiety, and irritability. As children spend substantial time in hot environments at school and at home, and as these conditions intensify with climate change, actions to safeguard their health are essential. Yet our understanding of heat exposure effects in children remains incomplete, hindering the development of evidence based strategies to protect them.
To address this gap, the investigators aim to evaluate whether an indoor temperature limit of 26 °C (45 percent relative humidity), the upper threshold recommended to protect older adults, can effectively prevent dangerous increases in physiological strain and declines in cognitive function in children during a simulated daylong heatwave. The preliminary study will assess physiological and cognitive responses in children aged 10 to 15 years during a 6 hour exposure (approximating a typical school day) to two conditions: (1) the recommended indoor temperature upper limit (26 °C) and (2) a high heat condition representative of homes and schools without air conditioning during extreme heat events (36 °C). In both conditions, children will remain seated at rest while wearing light clothing (t shirt and shorts), with the exception of performing 15 minutes of stepping exercise (6-6.5 METS) each hour (excluding the lunch period) to reflect typical daily activity in a school setting. This experimental design will allow investigators to determine whether maintaining indoor temperatures at the recommended upper limit for older adults sufficiently mitigates physiological strain in children.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure to indoor temperature upper limit of 26°C | Experimental | Other: Simulated exposure to indoor overheatingParticipants exposed daylong (6 hours) to an indoor temperature maintained at 26°C and 45% relative humidity (humidex equivalent of 29). |
| Exposure to hot indoor environment of 36°C | Experimental | Other: Simulated exposure to indoor overheatingParticipants exposed daylong (6 hours) to an indoor temperature maintained at 36°C and 45% relative humidity (humidex equivalent of 45). |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- English or French speaking.
- Ability to provide informed assent.
Key exclusion criteria (3 listed)
- Chronic health conditions
- Endurance exercise training (greater than 3 sessions of vigorous exercise training per week for 30 minutes or more)
- Restrictions to physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulated exposure to indoor overheatingChildren exposed to a 6-hour simulated heat exposure | Other | Exposure to hot indoor environment of 36°C, Exposure to indoor temperature upper limit of 26°C |
Primary outcome
Core temperature (Peak) during daylong exposure to indoor overheating
Time frame: End of 6 hour daylong exposure
Peak visceral temperature (15 min average) during exposure. Visceral temperature is measured continuously throughout the 6 hour exposure to the simulated indoor overheating.
28 secondary outcomes
Profiles of Mood States (POMS) during daylong exposure to indoor overheating
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
Environmental Symptoms Questionnaire (ESQ) during daylong exposure to indoor overheating
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
Perceived exertion scale during daylong exposure to indoor temperature limit.
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
Activity levels during daylong exposure to indoor overheating
Time frame: End of 6 hour daylong exposure
Feel good scale during daylong exposure to indoor overheating
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
Thirst sensation scale during daylong exposure to indoor overheating
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
Thermal comfort scale during daylong exposure to indoor overheating
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
Thermal sensation 2 scale during daylong exposure to indoor overheating
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
Thermal sensation scale during daylong exposure to indoor overheating
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
Fluid loss during daylong exposure to indoor overheating
Time frame: At end of 6 hour daylong exposure
Fluid consumption during daylong exposure to indoor overheating
Time frame: At end of 6 hour daylong exposure
Hydration status during daylong exposure to indoor overheating
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
BTrackS Balance Assessment during daylong exposure to indoor overheating (postural stability).
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
Executive function during daylong exposure to indoor overheating (cognitive function).
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
CDC 4-Stage Balance Test during daylong exposure to indoor overheating (postural stability).
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
Memory recall during daylong exposure to indoor overheating (cognitive function).
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
Impulse control during daylong exposure to indoor overheating (cognitive function).
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
Reaction time during daylong exposure to indoor overheating (cognitive function).
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
Diastolic blood pressure during daylong exposure to indoor overheating.
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
Systolic blood pressure during daylong exposure to indoor overheating
Time frame: At the start (hour 0) and end of 6 hour daylong exposure
Heart rate end of daylong exposure to indoor overheating
Time frame: End of 6 hour daylong exposure
Heart rate (AUC) during daylong exposure to indoor overheating
Time frame: End of 6 hour daylong exposure
Heat rate (Peak) during daylong exposure to indoor overheating
Time frame: End of 6 hour daylong exposure
Mean skin temperature end of daylong exposure to indoor overheating
Time frame: End of 6 hour daylong exposure
Mean skin temperature (AUC) during daylong exposure to indoor overheating
Time frame: End of 6 hour daylong exposure
Mean skin temperature (Peak) during daylong exposure to indoor overheating
Time frame: End of 6 hour daylong exposure
Core temperature end of daylong exposure to indoor overheating
Time frame: End of 6 hour daylong exposure
Core temperature (AUC) during daylong exposure to indoor overheating
Time frame: End of 6 hour daylong exposure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glen P Kenny, PhD principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated exposure to indoor overheating in people with Heat Stress and Physiological Stress, run by University of Ottawa at 1 site 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Glen P Kenny, PhD (613-562-5800 ext. 4282, gkenny@uottawa.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core temperature (Peak) during daylong exposure to indoor overheating (time frame: End of 6 hour daylong exposure). 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 23 Apr 2026.