An interventional study of Simulated exposure to indoor overheating in Heat Stress, Physiological Stress and Cognitive Change, sponsored by University of Ottawa. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by University of Ottawa · Not applicable, Interventional, and Basic science
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.
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 →University of Ottawa is the lead sponsor of 125 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 exposed daylong (6 hours) to an indoor temperature maintained at 26°C and 45% relative humidity (humidex equivalent of 29).
Other: Simulated exposure to indoor overheating
Participants exposed daylong (6 hours) to an indoor temperature maintained at 36°C and 45% relative humidity (humidex equivalent of 45).
Other: Simulated exposure to indoor overheating
Individuals with schizophrenia exposed to a 6-hour simulated heat exposure
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.
Time frame: End of 6 hour daylong exposure
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.
Time frame: 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 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").
Time frame: 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 an ordinal 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 6 hour daylong exposure
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.
Time frame: End of 6 hour daylong exposure
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)
Time frame: 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 an ordinal scale ranging from very, very thirsty to not thirsty at all.
Time frame: 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 an ordinal scale ("How comfortable does your body temperature feel?") ranging from "very uncomfortable" to "comfortable".
Time frame: 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 an ordinal scale ("How do you feel?") ranging from "hot" to "cold" (midpoint: neutral)
Time frame: 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 an ordinal scale (How hot do you feel?) ranging from "extremely hot" to "neutral".
Time frame: 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).
Time frame: 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).
Time frame: 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.
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).
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
Time frame: 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.
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).
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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: End of 6 hour daylong exposure
Started Nov 2025 (actual). Primary completion is estimated for May 2027, 18 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 18 months is above 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.