NCT07383324

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Nov 2025Jul 2027

Study Start

First participant enrolled

November 8, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

January 20, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

Indoor overheatingIndoor temperaturesHeat waveThermoregulationSchizophreniaHeat strainHeat vulnerabilityHyperthermiaMental healthThermal comfortPhysical activity

Outcome Measures

Primary Outcomes (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.

    End of 6 hour daylong exposure

Secondary Outcomes (28)

  • Profiles of Mood States (POMS) during daylong exposure to indoor overheating

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

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

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

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

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

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

    End of 6 hour daylong exposure

  • Feel good scale during daylong exposure to indoor overheating

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

  • +23 more secondary outcomes

Study Arms (2)

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).

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).

Other: Simulated exposure to indoor overheating

Interventions

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

Exposure to hot indoor environment of 36°CExposure to indoor temperature upper limit of 26°C

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

RECRUITING

MeSH Terms

Conditions

Heat Stress DisordersSchizophreniaHyperthermiaPsychological Well-BeingMotor Activity

Condition Hierarchy (Ancestors)

Wounds and InjuriesSchizophrenia Spectrum and Other Psychotic DisordersMental DisordersBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Study Officials

  • Glen P Kenny, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Glen P Kenny, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor, University Research Chair

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 3, 2026

Study Start

November 8, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations