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Heat Stress in Individuals With Schizophrenia

Impact of Indoor Overheating on Physiological Strain in Individuals With Schizophrenia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07383324
Enrollment
10
Registered
2026-02-03
Start date
2025-11-08
Completion date
2027-07-01
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Change, Heat Stress, Physiological Stress

Keywords

Indoor overheating, Indoor temperatures, Heat wave, Thermoregulation, Schizophrenia, Heat strain, Heat vulnerability, Hyperthermia, Mental health, Thermal comfort, Physical activity

Brief 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. 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.

Interventions

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

Sponsors

University of Ottawa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Core temperature (Peak) during daylong exposure to indoor overheatingEnd of 6 hour daylong exposurePeak 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.

Secondary

MeasureTime frameDescription
Profiles of Mood States (POMS) during daylong exposure to indoor overheatingAt the start (hour 0) and end of 6 hour daylong exposurePotential 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.
Environmental Symptoms Questionnaire (ESQ) during daylong exposure to indoor overheatingAt the start (hour 0) and end of 6 hour daylong exposureSelf-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").
Perceived exertion scale during daylong exposure to indoor temperature limit.At the start (hour 0) and end of 6 hour daylong exposurePerceived exertional assessed via an ordinal scale ("How hard are you working?") ranging from "no exertional at all" to "maximal exertion"
Activity levels (total steps taken) during daylong exposure to indoor overheatingEnd of 6 hour daylong exposureActivity 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.
Feel good scale during daylong exposure to indoor overheatingAt the start (hour 0) and end of 6 hour daylong exposureFeel good scale assessed via an ordinal scale (How good do you feel?) ranging from "very good" to "very bad" (midpoint: neutral)
Thirst sensation scale during daylong exposure to indoor overheatingAt the start (hour 0) and end of 6 hour daylong exposureThirst sensation assessed via an ordinal scale ranging from very, very thirsty to not thirsty at all.
Thermal comfort scale during daylong exposure to indoor overheatingAt the start (hour 0) and end of 6 hour daylong exposureThermal comfort assessed via an ordinal scale ("How comfortable does your body temperature feel?") ranging from "very uncomfortable" to "comfortable".
Thermal sensation 2 scale during daylong exposure to indoor overheatingAt the start (hour 0) and end of 6 hour daylong exposureThermal sensation assessed via an ordinal scale ("How do you feel?") ranging from "hot" to "cold" (midpoint: neutral)
Thermal sensation scale during daylong exposure to indoor overheatingAt the start (hour 0) and end of 6 hour daylong exposureThermal sensation assessed via an ordinal scale (How hot do you feel?) ranging from "extremely hot" to "neutral".
Fluid loss during daylong exposure to indoor overheatingAt end of 6 hour daylong exposureFluid loss calculated as the change in body mass during each exposure presented as a percentage of baseline body mass (corrected for food consumption).
Fluid consumption during daylong exposure to indoor overheatingAt end of 6 hour daylong exposureAverage hourly fluid consumption calculated by weighing participant water intake at the start and end of each hour of exposure (normalized to the exposure duration).
Hydration status during daylong exposure to indoor overheatingAt the start (hour 0) and end of 6 hour daylong exposureHydration status measured via assessing the urine specific gravity of a urine sample.
BTrackS Balance Assessment during daylong exposure to indoor overheating (postural stability).At the start (hour 0) and end of 6 hour daylong exposureTo 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
Executive function during daylong exposure to indoor overheating (cognitive function).At the start (hour 0) and end of 6 hour daylong exposureParticipants 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.
CDC 4-Stage Balance Test during daylong exposure to indoor overheating (postural stability).At the start (hour 0) and end of 6 hour daylong exposureTo 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).
Memory recall during daylong exposure to indoor overheating (cognitive function).At the start (hour 0) and end of 6 hour daylong exposureParticipants 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.
Impulse control during daylong exposure to indoor overheating (cognitive function).At the start (hour 0) and end of 6 hour daylong exposureParticipants 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.
Reaction time during daylong exposure to indoor overheating (cognitive function).At the start (hour 0) and end of 6 hour daylong exposureParticipants 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.
Diastolic blood pressure during daylong exposure to indoor overheating.At the start (hour 0) and end of 6 hour daylong exposureDiastolic blood pressure measured in triplicate via automated oscillometry (\~60 seconds between measures).
Systolic blood pressure during daylong exposure to indoor overheatingAt the start (hour 0) and end of 6 hour daylong exposureSystolic blood pressure measured in triplicate via automated oscillometry (\~60 seconds between measures).
Heart rate end of daylong exposure to indoor overheatingEnd of 6 hour daylong exposureHeart rate measured at hour 6 of exposure to indoor overheating (15-min average).
Heart rate (AUC) during daylong exposure to indoor overheatingEnd of 6 hour daylong exposureAreas under the curve (AUC) of heart rate during the 6 hour exposure to the simulate indoor overheating.
Heat rate (Peak) during daylong exposure to indoor overheatingEnd of 6 hour daylong exposurePeak heart rate (15 min average) during exposure. Heart rate is measured continuously throughout the 6 hour exposure to the simulated indoor overheating.
Mean skin temperature end of daylong exposure to indoor overheatingEnd of 6 hour daylong exposureMean skin temperature measured over 7 body regions at hour 6 of exposure to indoor overheating (15-min average).
Mean skin temperature (AUC) during daylong exposure to indoor overheatingEnd of 6 hour daylong exposureAreas under the curve (AUC) of mean skin temperature as calculated over 7 body regions during the 6 hour exposure to the simulate indoor overheating.
Mean skin temperature (Peak) during daylong exposure to indoor overheatingEnd of 6 hour daylong exposurePeak 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.
Core temperature end of daylong exposure to indoor overheatingEnd of 6 hour daylong exposureVisceral temperature measured at hour 6 of exposure to indoor overheating (15-min average).
Core temperature (AUC) during daylong exposure to indoor overheatingEnd of 6 hour daylong exposureAreas under the curve (AUC) of visceral temperature during the 6 hour exposure to the simulate indoor overheating.

Countries

Canada

Contacts

CONTACTGlen P Kenny, PhD
gkenny@uottawa.ca613-562-5800
PRINCIPAL_INVESTIGATORGlen P Kenny, PhD

University of Ottawa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026