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Chronic Obstructive Pulmonary Disease (COPD)NCT07852910

Indoor Overheating and Physiological Strain in Older Adults With COPD

A study testing Simulated indoor thermal environment in people with Chronic Obstructive Pulmonary Disease (COPD) and Heat Stress, run by University of Ottawa at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

During warm weather, homes without air conditioning can stay hot for long periods, and most heat-related health problems in Canada happen indoors rather than outdoors. Health Canada recommends that indoor temperatures not exceed 26 °C in homes occupied by people who are more susceptible to heat. Read more about this study

Who is it for?
Ages 60 to 80 years
What is being tested?
Simulated indoor thermal environment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteCanada
Study dates
13 Oct 2026to 31 May 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 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 60 to 80 years
  • Physician diagnosis of chronic obstructive pulmonary disease made at least 5 years previously
  • Clinically stable, with no acute exacerbation or active respiratory infection in the preceding 6 weeks
  • Current non-smoker
  • Able to communicate in English or French and to provide written informed consent

Who cannot join

  • Physical restriction preventing safe participation, including unstable cardiac or pulmonary disease, uncontrolled hypertension (resting blood pressure exceeding 150/95 mmHg), severe arthritis, renal impairment, active proliferative retinopathy, history of disabling stroke, or intermittent claudication
  • Recent change in medications judged by the investigators to make participation inadvisable
  • Cardiac abnormalities identified on electrocardiogram during the screening exercise test
  • Regular work or exercise in hot environments (heat acclimatized)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nicholas Goulet, MSc contact

613-322-9930

ngoul043@uottawa.ca

Pascal Imbeault, PhD contact

imbeault@uottawa.ca

Canada1 site
  • University of Ottawa

    Ottawa, Ontario, K1N 6N5

    Nicholas Goulet, MSc, 613-322-9930, ngoul043@uottawa.ca

    Glen P Kenny, PhD, gkenny@uottawa.ca

Other trials in Canada

About this study

Official title: The Impact of Extreme Heat on Individuals Living With Chronic Obstructive Pulmonary Disease: A Randomized Crossover Trial of Day-Long Passive Indoor Heat Exposure

During warm weather, homes without air conditioning can stay hot for long periods, and most heat-related health problems in Canada happen indoors rather than outdoors. Health Canada recommends that indoor temperatures not exceed 26 °C in homes occupied by people who are more susceptible to heat. That recommendation is based largely on population-level evidence, and very little is known about how susceptible individuals actually respond, physiologically, when indoor temperatures rise above it.

Older adults living with chronic obstructive pulmonary disease (COPD) are among the groups identified as more susceptible to heat. COPD involves persistent airflow limitation, reduced lung and cardiovascular reserve, and altered cellular stress responses. Despite this, no laboratory study has directly measured how adults with COPD respond to a full day spent indoors in warm conditions.

Read more

This randomized crossover trial will measure how older adults with COPD respond to two different indoor environments, each experienced for eight hours on separate days at least one week apart. One day is spent at the recommended indoor temperature limit and the other at a warmer temperature representative of conditions recorded inside Canadian homes during hot weather. Participants remain seated and rest throughout; no exercise or work is performed.

Throughout each day, the research team continuously measures core body temperature, skin temperature, heart rate, and measures blood pressure, lung function, breathlessness, thermal comfort, cognitive performance, and balance at set time points. Blood and urine samples are collected at the start and end of each day. Participants are monitored continuously by trained staff.

The results are intended to strengthen the evidence base behind Canadian indoor temperature guidance and to inform recommendations for protecting people living with chronic lung disease during hot weather.

Being tested
Simulated indoor thermal environment
Keywords
indoor overheating, extreme heat, thermoregulation, core temperature, pulmonary function
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Heat Stress Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simulated indoor thermal environmentOther

    Day-long (8 h) passive exposure in a climate-controlled environmental chamber at a set air temperature and relative humidity. Participants remain seated or resting.

Study groups in NCT07852910
Study groupRoleWhat they receive
Recommended indoor temperature limit (26 °C)Active comparatorEight-hour passive seated exposure to an indoor environment maintained at 26 °C and 45% relative humidity, corresponding to the recommended upper indoor temperature limit for heat-susceptible occupants.
Receives: Other: Simulated indoor thermal environment
Indoor overheating (36 °C)ExperimentalEight-hour passive seated exposure to an indoor environment maintained at 36 °C and 45% relative humidity, representing warm indoor conditions recorded inside Canadian dwellings without mechanical cooling during heat events.
Receives: Other: Simulated indoor thermal environment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Core temperature (Peak)

    Peak rectal temperature (15 min average) during exposure. Rectal temperature is measured continuously throughout the simulated indoor overheating exposure.

    Measured: End of 8-hour exposure

Secondary outcomes (29)
  1. Profiles of Mood States (POMS)

    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 were 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) were summed to calculate its score.

    Measured: At the start (hour 0) and end of exposure (hour 8)

  2. Environmental Symptoms Questionnaire (ESQ)

    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 [24, 25]. 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 was 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 exposure (hour 8)

  3. Orthostatic intolerance symptoms assessment

    Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance during the lying to standing tests. All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort".

    Measured: At the start (hour 0) and end of exposure (hour 8)

  4. Perceived arousal (Felt Arousal Scale)

    Perceived arousal assessed using the Felt Arousal Scale, a single-item 6-point numerical rating scale on which participants respond to the question "How worked up are you?" Scores range from a minimum of 1 (low arousal) to a maximum of 6 (high arousal).

    Measured: End of 8-hour exposure

  5. Perceived thirst (Thirst Sensation Scale)

    Perceived thirst assessed using the Thirst Sensation Scale, a single-item 9-point numerical rating scale on which participants respond to the question "How thirsty do you feel now?" Scores range from a minimum of 1 to a maximum of 9, with verbal anchors at 1 (not thirsty at all), 3 (a little thirsty), 5 (moderately thirsty), 7 (very thirsty), and 9 (very, very thirsty).

    Measured: End of 8-hour exposure

  6. Thermal sensation (American Society of Heating, Refrigerating and Air-Conditioning Engineers thermal sensation scale)

    Thermal sensation assessed using the thermal sensation scale defined in ANSI/ASHRAE Standard 55 (American Society of Heating, Refrigerating and Air-Conditioning Engineers), a single-item 7-point bipolar rating scale on which participants respond to the question "How do you feel right now?" Scores range from a minimum of -3 (cold) to a maximum of +3 (hot), with 0 indicating a neutral thermal sensation.

    Measured: End of 8-hour exposure

  7. Thermal comfort (American Society of Heating, Refrigerating and Air-Conditioning Engineers thermal comfort scale)

    Thermal comfort assessed using the thermal comfort scale defined in ANSI/ASHRAE Standard 55 (American Society of Heating, Refrigerating and Air-Conditioning Engineers), a single-item 4-point rating scale on which participants respond to the question "How comfortable do you feel right now?" Scores range from a minimum of 1 (comfortable) to a maximum of 4 (very uncomfortable).

    Measured: End of 8-hour exposure

  8. Change in plasma volume

    Change in plasma volume from baseline values calculated from duplicate measurements of hemoglobin and hematocrit at the start and end of each exposure using the technique by Dill and Costill

    Measured: End of 8-hour exposure

  9. Fluid loss

    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: End of 8-hour exposure

  10. Fluid consumption

    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: End of 8-hour exposure

  11. Heart rate variability: RMSSD

    Root mean squared standard deviation of normal-to-normal R-wave to R-wave intervals (RMSSD) measured during 5 minutes of paced breathing (15 breaths/min) with participants in the seated position. RMSSD will be evaluated twice, during two paced breathing periods (separated by 4 min of seated rest).

    Measured: At the start (hour 0) and end of exposure (hour 8)

  12. Heart rate variability: SDNN

    Standard deviation of normal-to-normal R-wave to R-wave intervals (SDNN) measured during 5 minutes of paced breathing (15 breaths/min) with participants in the seated position. SDNN will be evaluated twice, during two paced breathing periods (separated by 4 min of seated rest).

    Measured: At the start (hour 0) and end of exposure (hour 8)

  13. Rate pressure product

    Rate pressure product, an index of myocardial work and strain, calculated as systolic blood pressure x heart rate.

    Measured: End of 8-hour exposure

  14. Diastolic blood pressure

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

    Measured: End of 8-hour exposure

  15. Systolic blood pressure

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

    Measured: End of 8-hour exposure

  16. Systolic Response to Standing From Supine

    Systolic blood pressure response to standing evaluated as the difference in blood pressure measured between the standing and supine. Standing systolic blood pressure will be taken as the lowest value of those measured after 60 and 120 seconds of standing. Systolic response to standing will be evaluated twice, during two lying-to-standing tests (separated by 10 min of supine rest).

    Measured: At the start (hour 0) and end of exposure (hour 8)

  17. CDC 4-Stage Balance Test (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 exposure (hour 8)

  18. Executive function (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 colour-word tasks.

    Measured: At the start (hour 0) and end of exposure (hour 8)

  19. Memory recall (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 exposure (hour 8)

  20. Impulse control (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 exposure (hour 8)

  21. Reaction time (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 exposure (hour 8)

  22. Cardiac response to standing from supine (30:15 Ratio)

    Cardiac response to standing evaluated as the ratio between the highest R-wave to R-wave interval (lowest heart rate) measured at the 30th heart beat after standing from supine (+/- 5 beats) and the lowest R-wave to R-wave interval (highest heart rate) measured at the 15th heart beat after standing (+/- 5 beats). Cardiac response to standing will be evaluated twice, during two lying-to-standing tests (separated by 10 min of supine rest). Assessment is performed in the morning prior to and following daytime exposure.

    Measured: At the start (hour 0) and end of exposure (hour 8)

  23. Heart rate (AUC)

    Area under the curve of heart rate (in bpm-hours)

    Measured: End of 8-hour exposure

  24. Heart rate (Peak)

    Peak Heart rate (15-min average) during the 8-hour exposure

    Measured: End of 8-hour exposure

  25. Core temperature (AUC)

    Area under the curve of rectal temperature (in degree-hours)

    Measured: End of 8-hour exposure

  26. Core temperature (hourly)

    Rectal temperature measured at each hour of exposure (15-min average)

    Measured: Hourly during the 8-hour exposure

  27. Mean skin temperature (Peak)

    Peak mean skin temperature (15-min average) during the 8-hour exposure

    Measured: End of 8-hour exposure

  28. Mean skin temperature (AUC)

    Area under the curve of mean skin temperature (in degree-hours)

    Measured: End of 8-hour exposure

  29. Urine specific gravity

    Urine specific gravity measured by handheld refractometer

    Measured: At the start (hour 0) and end of exposure (hour 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2026
  2. Study start13 Oct 2026 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 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
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07852910
Sponsor's protocol ID
H-08-26-13258
Status last verified
Aug 2026
First submitted
25 Sep 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Simulated indoor thermal environment in people with Chronic Obstructive Pulmonary Disease (COPD) and Heat 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Oct 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 Nicholas Goulet, MSc (613-322-9930, ngoul043@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) (time frame: End of 8-hour 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 5 Oct 2026.

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