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Heat StressNCT07383324

Heat Stress in Individuals With Schizophrenia

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Schizophrenia is a severe mental illness affecting approximately 24 million people worldwide and is associated with more than double the all cause mortality risk of the general population. Read more about this study

Who is it for?
Ages 18 to 85 years
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 1 Jul 2027
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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • English or French speaking.
  • Ability to provide informed consent.
  • Individuals with and without schizophrenia or schizoaffective disorder.

Who cannot join

  • Endurance exercise training (greater than 3 sessions of vigorous exercise training per week for 30 minutes or more)
  • Restrictions to physical activity
  • Any history of diagnoses for other psychiatric disorders deemed to make participation in the study inadvisable.

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
  • University of Ottawa

    Ottawa, Ontario, K1N 6N5

    Glen P Kenny, PhD, 613-562-5800 ext. 4282, gkenny@uottawa.ca

    Recruiting

Other trials in Canada

About this study

Official title: Impact of Indoor Overheating on Physiological Strain in Individuals With Schizophrenia

Schizophrenia is a severe mental illness affecting approximately 24 million people worldwide and is associated with more than double the all cause mortality risk of the general population. Emerging evidence demonstrates that elevated temperatures acutely worsen mental health symptoms and significantly increase the risk of heat related morbidity and mortality. For people living with schizophrenia, prolonged exposure to heat can exacerbate psychiatric symptoms, impair judgment and decision making, and reduce the ability to engage in protective behaviors such as increasing hydration, reducing clothing, improving ventilation, or seeking cooler environments. As a result, individuals with schizophrenia may experience higher rates of heat related illness. To date our understanding of heat exposure effects in individuals with schizophrenia remains incomplete, hindering the development of evidence-based strategies to protect them.

Thus, the primary objective of this exploratory study is to gather preliminary data on the effects of indoor overheating on physiological responses (core body temperature and cardiovascular function), cognitive performance (attention, working memory, and reaction time), and mood in adults with schizophrenia. Specifically, we will assess whether maintaining indoor conditions at the upper recommended temperature limit for older adults (26°C, 45% relative humidity [RH]; PMID: 38329752) is sufficient to mitigate physiological strain compared with exposure to a hot indoor environment (36°C, 45% RH) representative of non-air-conditioned homes during extreme heat events in individuals with schizophrenia. In both conditions, the individual will remain seated at rest while wearing light clothing (t shirt and shorts), with the exception of performing 15 minutes of stepping exercise (4-4.5 METS) each hour (excluding the lunch period) to reflect typical daily activities of daily living.

Being tested
Simulated exposure to indoor overheating
Keywords
Indoor overheating, Indoor temperatures, Heat wave, Thermoregulation, Schizophrenia, Heat strain, Heat vulnerability, Hyperthermia, Mental health, Thermal comfort, Physical activity
Medical subject headings
Heat Stress Disorders, Schizophrenia, Hyperthermia, Psychological Well-Being, 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

    Individuals with schizophrenia exposed to a 6-hour simulated heat exposure

Study groups in NCT07383324
Study groupRoleWhat they receive
Exposure to indoor temperature upper limit of 26°CExperimentalParticipants 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°CExperimentalParticipants 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.

  1. Core temperature (Peak) during daylong exposure to indoor overheating

    Peak core (indexed by visceral temperature) 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)
  1. 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 are 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) are summed to calculate its score.

    Measured: At the start (hour 0) and end of 6 hour daylong exposure

  2. 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 is 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

  3. Perceived exertion scale during daylong exposure to indoor temperature limit.

    Perceived exertional assessed via an ordinal 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

  4. Activity levels (total steps taken) during daylong exposure to indoor overheating

    Activity levels, quantified by number of steps taken per hour and totaled for each 6 hour exposure, assessed via a wearable accelerometer worn on the wrist and hip.

    Measured: End of 6 hour daylong exposure

  5. Feel good scale during daylong exposure to indoor overheating

    Feel good scale assessed via an ordinal 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

  6. Thirst sensation scale during daylong exposure to indoor overheating

    Thirst sensation assessed via an ordinal scale ranging from very, very thirsty to not thirsty at all.

    Measured: At the start (hour 0) and end of 6 hour daylong exposure

  7. Thermal comfort scale during daylong exposure to indoor overheating

    Thermal comfort assessed via an ordinal 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

  8. Thermal sensation 2 scale during daylong exposure to indoor overheating

    Thermal sensation assessed via an ordinal 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

  9. Thermal sensation scale during daylong exposure to indoor overheating

    Thermal sensation assessed via an ordinal 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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.

  1. First posted3 Feb 2026
  2. Study start8 Nov 2025
  3. Primary completion31 May 2027 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07383324
Sponsor's protocol ID
HEPRU-2026-01-A
Status last verified
Apr 2026
First submitted
20 Jan 2026
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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 3 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.

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