- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07864103
Efficacy of Electric Fans in Children During Heat Waves
Effectiveness of Heat Mitigation Strategies in Mitigating Increases in Physiological Strain in Children and Youth Exposed to Indoor Overheating
Extreme heat exposure is an escalating global public health concern, with climate change driving increases in the frequency, duration, and intensity of heat events. Projections indicate substantial increases in heat-related morbidity and mortality in the coming decades, including among children and youth, who are increasingly recognized as a physiologically vulnerable population. The purpose of this project is to evaluate the effectiveness of commonly used heat-mitigation strategies, specifically midday access daylong electric fan use, in reducing physiological strain and maintaining cognitive function, perceptual comfort, and psychological well-being in children and youth exposed to prolonged indoor heat. The study also aims to determine whether these strategies provide comparable protection in children and youth relative to young adults. Participants will complete four sessions under the same environmental conditions (31°C and 36°C), with each temperature completed twice: once with continuous electric fan use and once without fan use. The four sessions therefore consist of: (1) 31°C without fan use; (2) 31°C with fan use; (3) 36°C without fan use; and (4) 36°C with fan use.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Glen P Kenny
- Número de teléfono: 4282 613-562-5800
- Correo electrónico: gkenny@uottawa.ca
Ubicaciones de estudio
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Ontario
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Ottawa, Ontario, Canadá, K1N 6N5
- Reclutamiento
- University of Ottawa
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Contacto:
- Glen P Kenny
- Número de teléfono: 4282 613-562-5800
- Correo electrónico: gkenny@uottawa.ca
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participants must be healthy males or females within the specified age ranges (9-12 years, 13-16 years, or 20-25 years).
- All participants must be habitually active, defined as participation in regular physical activity at least three times per week for a minimum of 20 minutes per session over the previous six months.
- Participants must be able to understand and communicate in English or French.
- For participants under 18 years of age, written parental or guardian consent and participant assent will be required prior to participation.
Exclusion Criteria:
- Individuals will be excluded from participation if they have any acute illness at the time of testing (e.g., cold, flu, or infection), or a history of chronic medical conditions that may affect thermoregulation, cardiovascular function, or exercise capacity, including but not limited to cardiovascular, metabolic, respiratory, or neurological disorders. Individuals taking medications known to influence thermoregulation, hydration status, or cardiovascular responses will also be excluded.
- Participants with a history of heat-related illness (e.g., heat exhaustion or heat stroke) will not be eligible.
- Individuals with digestive abnormalities or gastrointestinal conditions that may contraindicate ingestion of a telemetry pill will also be excluded.
- Any individual who, in the opinion of the investigators, may be at increased risk or unable to safely complete the study procedures will be excluded.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Warm indoor environment of 31°C without fans
Participants exposed daylong (6 hours) to an indoor temperature maintained at 31°C and 45% relative humidity without fan exposure. |
Children and young adults exposed to a 6-hour simulated heat exposure without fans. |
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Experimental: Warm indoor environment of 31°C with fans
Participants exposed daylong (6 hours) to an indoor temperature maintained at 31°C and 45% relative humidity with fan exposure. |
Children and young adults exposed to a 6-hour simulated heat exposure without fans. |
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Experimental: Hot indoor environment of 36°C without fans
Participants exposed daylong (6 hours) to an indoor temperature maintained at 36°C and 45% relative humidity with fan exposure. |
Children and young adults exposed to a 6-hour simulated heat exposure without fans. |
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Experimental: Hot indoor environment of 36°C with fans
Participants exposed daylong (6 hours) to an indoor temperature maintained at 36°C and 45% relative humidity with fan exposure. |
Children and young adults exposed to a 6-hour simulated heat exposure without fans. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Core temperature (Peak) during daylong exposure to indoor overheating
Periodo de tiempo: End of 6 hour daylong exposure
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Profiles of Mood States (POMS) during daylong exposure to indoor overheating
Periodo de tiempo: 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. |
At the start (hour 0) and end of 6 hour daylong exposure
|
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Environmental Symptoms Questionnaire (ESQ) during daylong exposure to indoor overheating
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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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"). |
At the start (hour 0) and end of 6 hour daylong exposure
|
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Perceived exertion scale during daylong exposure to indoor temperature limit
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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Perceived exertional assessed via an ordinal scale ("How hard are you working?") ranging from "no exertional at all" to "maximal exertion" |
At the start (hour 0) and end of 6 hour daylong exposure
|
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Activity levels (total steps taken) during daylong exposure to indoor overheating
Periodo de tiempo: End of 6 hour daylong exposure
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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. |
End of 6 hour daylong exposure
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Feel good scale during daylong exposure to indoor overheating
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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Feel good scale assessed via an ordinal scale (How good do you feel?) ranging from "very good" to "very bad" (midpoint: neutral) |
At the start (hour 0) and end of 6 hour daylong exposure
|
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Thirst sensation scale during daylong exposure to indoor overheating
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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Thirst sensation assessed via an ordinal scale ranging from very, very thirsty to not thirsty at all. |
At the start (hour 0) and end of 6 hour daylong exposure
|
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Thermal comfort scale during daylong exposure to indoor overheating
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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Thermal comfort assessed via an ordinal scale ("How comfortable does your body temperature feel?") ranging from "very uncomfortable" to "comfortable". |
At the start (hour 0) and end of 6 hour daylong exposure
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Thermal sensation 2 scale during daylong exposure to indoor overheating
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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Thermal sensation assessed via an ordinal scale ("How do you feel?") ranging from "hot" to "cold" (midpoint: neutral) |
At the start (hour 0) and end of 6 hour daylong exposure
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Thermal sensation scale during daylong exposure to indoor overheating
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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Thermal sensation assessed via an ordinal scale (How hot do you feel?) ranging from "extremely hot" to "neutral". |
At the start (hour 0) and end of 6 hour daylong exposure
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Fluid loss during daylong exposure to indoor overheating
Periodo de tiempo: At end of 6 hour daylong exposure
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Fluid loss calculated as the change in body mass during each exposure presented as a percentage of baseline body mass (corrected for food consumption). |
At end of 6 hour daylong exposure
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Fluid consumption during daylong exposure to indoor overheating
Periodo de tiempo: At end of 6 hour daylong exposure
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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). |
At end of 6 hour daylong exposure
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Hydration status during daylong exposure to indoor overheating
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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Hydration status measured via assessing the urine specific gravity of a urine sample. |
At the start (hour 0) and end of 6 hour daylong exposure
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BTrackS Balance Assessment during daylong exposure to indoor overheating (postural stability)
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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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 |
At the start (hour 0) and end of 6 hour daylong exposure
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Executive function during daylong exposure to indoor overheating (cognitive function).
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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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. |
At the start (hour 0) and end of 6 hour daylong exposure
|
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CDC 4-Stage Balance Test during daylong exposure to indoor overheating (postural stability).
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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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). |
At the start (hour 0) and end of 6 hour daylong exposure
|
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Memory recall during daylong exposure to indoor overheating (cognitive function).
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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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. |
At the start (hour 0) and end of 6 hour daylong exposure
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Impulse control during daylong exposure to indoor overheating (cognitive function).
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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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. |
At the start (hour 0) and end of 6 hour daylong exposure
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Reaction time during daylong exposure to indoor overheating (cognitive function).
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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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. |
At the start (hour 0) and end of 6 hour daylong exposure
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Diastolic blood pressure during daylong exposure to indoor overheating.
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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Diastolic blood pressure measured in triplicate via automated oscillometry (~60 seconds between measures). |
At the start (hour 0) and end of 6 hour daylong exposure
|
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Systolic blood pressure during daylong exposure to indoor overheating
Periodo de tiempo: At the start (hour 0) and end of 6 hour daylong exposure
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Systolic blood pressure measured in triplicate via automated oscillometry (~60 seconds between measures). |
At the start (hour 0) and end of 6 hour daylong exposure
|
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Heart rate end of daylong exposure to indoor overheating
Periodo de tiempo: End of 6 hour daylong exposure
|
Heart rate measured at hour 6 of exposure to indoor overheating (15-min average). |
End of 6 hour daylong exposure
|
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Heart rate (AUC) during daylong exposure to indoor overheating
Periodo de tiempo: End of 6 hour daylong exposure
|
Areas under the curve (AUC) of heart rate during the 6 hour exposure to the simulate indoor overheating. |
End of 6 hour daylong exposure
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Heat rate (Peak) during daylong exposure to indoor overheating
Periodo de tiempo: 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. |
End of 6 hour daylong exposure
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Mean skin temperature end of daylong exposure to indoor overheating
Periodo de tiempo: End of 6 hour daylong exposure
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Mean skin temperature measured over 7 body regions at hour 6 of exposure to indoor overheating (15-min average). |
End of 6 hour daylong exposure
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Mean skin temperature (AUC) during daylong exposure to indoor overheating
Periodo de tiempo: End of 6 hour daylong exposure
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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. |
End of 6 hour daylong exposure
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Mean skin temperature (Peak) during daylong exposure to indoor overheating
Periodo de tiempo: 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. |
End of 6 hour daylong exposure
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Core temperature end of daylong exposure to indoor overheating
Periodo de tiempo: End of 6 hour daylong exposure
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Visceral temperature measured at hour 6 of exposure to indoor overheating (15-min average). |
End of 6 hour daylong exposure
|
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Core temperature (AUC) during daylong exposure to indoor overheating
Periodo de tiempo: End of 6 hour daylong exposure
|
Areas under the curve (AUC) of visceral temperature during the 6 hour exposure to the simulate indoor overheating. |
End of 6 hour daylong exposure
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HEPRU-2026-10-C
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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