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Trial · NCT07261202

Registered outcomes29

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryCore temperature (Peak) during daylong exposure to indoor overheatingEnd of 6 hour daylong exposure
Peak visceral temperature (15 min average) during exposure. Visceral temperature is measured continuously throughout the 6 hour exposure to the simulated indoor overheating. A 0.2°C between-group difference will be considered the smallest physiologically meaningful effect.
SecondaryProfiles of Mood States (POMS) during daylong exposure to indoor overheatingAt 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 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.
SecondaryEnvironmental Symptoms Questionnaire (ESQ) during daylong exposure to indoor overheatingAt 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 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").
SecondaryPerceived exertion scale during daylong exposure to indoor temperature limit.At the start (hour 0) and end of 6 hour daylong exposurePerceived exertional assessed via a visual analog scale ("How hard are you working?") ranging from "no exertional at all" to "maximal exertion"
SecondaryActivity levels during daylong exposure to indoor overheatingEnd of 6 hour daylong exposureActivity levels assessed via a wearable monitor (Actical) containing an accelerometer worn on the wrist and hip.
SecondaryFeel good scale during daylong exposure to indoor overheatingAt the start (hour 0) and end of 6 hour daylong exposureFeel good scale assessed via a visual analog scale (How good do you feel?) ranging from "very good" to "very bad" (midpoint: neutral)
SecondaryThirst sensation scale during daylong exposure to indoor overheatingAt the start (hour 0) and end of 6 hour daylong exposureThirst sensation assessed via a visual analog scale ranging from very, very thirsty to not thirsty at all.
SecondaryThermal comfort scale during daylong exposure to indoor overheatingAt the start (hour 0) and end of 6 hour daylong exposureThermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") ranging from "very uncomfortable" to "comfortable".
SecondaryThermal sensation 2 scale during daylong exposure to indoor overheatingAt the start (hour 0) and end of 6 hour daylong exposureThermal sensation assessed via a visual analog scale ("How do you feel?") ranging from "hot" to "cold"(midpoint: neutral)
SecondaryThermal sensation scale during daylong exposure to indoor overheatingAt the start (hour 0) and end of 6 hour daylong exposureThermal sensation assessed via a visual analog scale (How hot do you feel?) ranging from "extremely hot" to "neutral".
SecondaryFluid 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).
SecondaryFluid 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).
SecondaryHydration 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.
SecondaryBTrackS Balance Assessment during daylong exposure to indoor overheating (postural stability).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
SecondaryExecutive function during daylong exposure to indoor overheating (cognitive function).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.
SecondaryCDC 4-Stage Balance Test during daylong exposure to indoor overheating (postural stability).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).
SecondaryMemory recall during daylong exposure to indoor overheating (cognitive function).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.
SecondaryImpulse control during daylong exposure to indoor overheating (cognitive function).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.
SecondaryReaction time during daylong exposure to indoor overheating (cognitive function).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.
SecondaryDiastolic 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).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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