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NCT Number: NCT07383324

Heat Stress 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

Location status: Recruiting

Location contact

Glen P Kenny, PhD

CONTACT

[email protected]

613-562-5800 ext. 4282

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Simulated exposure to indoor overheating

Other

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

Primary outcomes

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

    Time frame: End of 6 hour daylong exposure

    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.

Secondary outcomes

  1. 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

    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.

  2. Environmental Symptoms Questionnaire (ESQ) during daylong exposure to indoor overheating

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

    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").

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

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

    Perceived exertional assessed via an ordinal scale ("How hard are you working?") ranging from "no exertional at all" to "maximal exertion"

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

    Time frame: End of 6 hour daylong exposure

    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.

  5. Feel good scale during daylong exposure to indoor overheating

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

    Feel good scale assessed via an ordinal scale (How good do you feel?) ranging from "very good" to "very bad" (midpoint: neutral)

  6. Thirst sensation scale during daylong exposure to indoor overheating

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

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

  7. Thermal comfort scale during daylong exposure to indoor overheating

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

    Thermal comfort assessed via an ordinal scale ("How comfortable does your body temperature feel?") ranging from "very uncomfortable" to "comfortable".

  8. 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 assessed via an ordinal scale ("How do you feel?") ranging from "hot" to "cold" (midpoint: neutral)

  9. Thermal sensation scale during daylong exposure to indoor overheating

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

    Thermal sensation assessed via an ordinal scale (How hot do you feel?) ranging from "extremely hot" to "neutral".

  10. Fluid loss during daylong exposure to indoor overheating

    Time frame: At end of 6 hour daylong exposure

    Fluid loss calculated as the change in body mass during each exposure presented as a percentage of baseline body mass (corrected for food consumption).

  11. Fluid consumption during daylong exposure to indoor overheating

    Time frame: At end of 6 hour daylong exposure

    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).

  12. Hydration status during daylong exposure to indoor overheating

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

    Hydration status measured via assessing the urine specific gravity of a urine sample.

  13. 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

    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

  14. Executive function during daylong exposure to indoor overheating (cognitive function).

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

    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.

  15. 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

    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).

  16. Memory recall during daylong exposure to indoor overheating (cognitive function).

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

    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.

  17. Impulse control during daylong exposure to indoor overheating (cognitive function).

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

    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.

  18. Reaction time during daylong exposure to indoor overheating (cognitive function).

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

    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.

  19. Diastolic blood pressure during daylong exposure to indoor overheating.

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

    Diastolic blood pressure measured in triplicate via automated oscillometry (~60 seconds between measures).

  20. Systolic 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 measured in triplicate via automated oscillometry (~60 seconds between measures).

  21. Heart rate end of daylong exposure to indoor overheating

    Time frame: End of 6 hour daylong exposure

    Heart rate measured at hour 6 of exposure to indoor overheating (15-min average).

  22. Heart rate (AUC) during daylong exposure to indoor overheating

    Time frame: End of 6 hour daylong exposure

    Areas under the curve (AUC) of heart rate during the 6 hour exposure to the simulate indoor overheating.

  23. Heat rate (Peak) during daylong exposure to indoor overheating

    Time frame: End of 6 hour daylong exposure

    Peak heart rate (15 min average) during exposure. Heart rate is measured continuously throughout the 6 hour exposure to the simulated indoor overheating.

  24. Mean skin temperature end of daylong exposure to indoor overheating

    Time frame: End of 6 hour daylong exposure

    Mean skin temperature measured over 7 body regions at hour 6 of exposure to indoor overheating (15-min average).

  25. Mean skin temperature (AUC) during daylong exposure to indoor overheating

    Time frame: End of 6 hour daylong exposure

    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.

  26. Mean skin temperature (Peak) during daylong exposure to indoor overheating

    Time frame: End of 6 hour daylong exposure

    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.

  27. Core temperature end of daylong exposure to indoor overheating

    Time frame: End of 6 hour daylong exposure

    Visceral temperature measured at hour 6 of exposure to indoor overheating (15-min average).

  28. Core temperature (AUC) during daylong exposure to indoor overheating

    Time frame: End of 6 hour daylong exposure

    Areas under the curve (AUC) of visceral temperature during the 6 hour exposure to the simulate indoor overheating.

Study contacts

Contact information is provided by the study sponsor or research team.

Glen P Kenny, PhD

CONTACT

[email protected]

613-562-5800 ext. 4282

Sponsors and collaborators

Lead sponsor

University of Ottawa

Other

Registry information

Official study title

Impact of Indoor Overheating on Physiological Strain in Individuals With Schizophrenia

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 3, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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