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临床试验/NCT06633302
NCT06633302已完成不适用

Evaluating the Efficacy of a 26°C Indoor Temperature for Limiting Thermal and Cardiovascular Strain in Older Adults During a Simulated Multi-day Heat Event

University of Ottawa2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Core temperature (Peak) during daytime

研究概览

简要总结

A recent report showed that maintaining indoor temperature at or below 26°C safeguards older, heat vulnerable adults against potentially dangerous increases in thermal and cardiovascular strain during an extreme heat event (PMID: 38329752). However, this proposed limit does not consider the potential cumulative effect of successive days of heat exposure, which could lead to a progressive deterioration in thermoregulatory and cardiovascular function and necessitate adjustments to upper indoor temperature limits. Further, thermal comfort and quality of sleep may be negatively impacted when bedroom temperatures exceed 24°C (PMID: 3090680). On this basis, some health agencies have recommended that bedroom temperatures at night should not exceed 26°C unless ceiling fans are available (PMID: 3090680). Currently, however, it is unknown whether indoor overheating impairs sleep quality and physiological strain on a subsequent day in older adults and, if so, whether maintaining indoor temperature at 26°C is sufficient to prevent these adverse health impacts.

With rising global temperatures and more extreme heat events, energy management strategies to limit the strain on the power grid during the daytime are now increasingly commonplace. Thus, understanding the benefits of maintaining indoor temperature at the recommend upper limits of 26°C during the nighttime only on surrogate physiological indicators of health is an important step in understanding how to optimize protection for heat-vulnerable older adults when power outages occur.

The investigators will assess the efficacy of proposed indoor temperature limits (i.e., 26°C) in mitigating increases in core temperature and cardiovascular strain over three consecutive days (3 days, 2 nights) in older adults (60-85 years) with (indoor temperatures maintained at the recommend 26°C at all times throughout the three days) and without (daytime temperature fixed at 34°C (temperature experienced in homes without air-conditioning during an extreme heat event) with nighttime temperature at 26°C) access to daytime cooling. By quantifying the effect of daylong indoor overheating on surrogate physiological outcomes linked with heat-related mortality and morbidity in older adults, the investigators can determine if refinements in the recommended upper temperature threshold is required, including best practices when power outages may occur during an extreme heat event.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-smoking.
  • English or French speaking.
  • Ability to provide informed consent.
  • with or without a) chronic hypertension (elevated resting blood pressure; as defined by Heart and Stroke Canada and Hypertension Canada), b) type 2 diabetes as defined by Diabetes Canada, with at least 5 years having elapsed since time of diagnosis

排除标准

  • Episode(s) of severe hypoglycemia (requiring the assistance of another person) within the previous year, or inability to sense hypoglycemia (hypoglycemia unawareness).
  • Serious complications related to your diabetes (gastroparesis, renal disease, uncontrolled hypertension, severe autonomic neuropathy).
  • Uncontrolled hypertension - BP >150 mmHg systolic or >95 mmHg diastolic in a sitting position.
  • Restrictions in physical activity due to disease (e.g. intermittent claudication, renal impairment, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis, etc.).
  • Use of or changes in medication judged by the patient or investigators to make participation in this study inadvisable.
  • Cardiac abnormalities identified during screening

结局指标

主要结局

Core temperature (Peak) during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

Peak rectal temperature (15 min average) during exposure. Rectal temperature is measured continuously throughout the daytime period of the simulated heat wave.

Core temperature (AUC) during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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

Core temperature end of daytime exposure

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

Rectal temperature measured at hour 10 of each daytime exposure to simulated heat wave (15-min average)

Heat rate peak during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

Heart rate during each daytime exposure to simulated heat wave (15-min average)

Heat rate AUC during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

Heart rate measured during each daytime exposure to simulated heat wave (15-min average)

Cardiac response to standing from supine (30:15 Ratio) during daytime

时间窗: At the start (hour 0) and end of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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.

Reaction time during daytime (cognitive function)

时间窗: At the start (hour 0) and end of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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.

Impulse control during daytime (cognitive function)

时间窗: At the start (hour 0) and end of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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.

Memory recall during daytime (cognitive function)

时间窗: At the start (hour 0) and end of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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.

Executive function during daytime (cognitive function)

时间窗: At the start (hour 0) and end of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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.

CDC 4-Stage Balance Test during daytime (Postural stability)

时间窗: At the start (hour 0) and end of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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).

BTrackS Balance Assessment during daytime (Postural stability)

时间窗: At the start (hour 0) and end of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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.

Systolic Response to Standing From Supine during daytime

时间窗: At the start (hour 0) and end of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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).

Systolic blood pressure during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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

Diastolic blood pressure during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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

Rate pressure product during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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

Heart rate variability: SDNN during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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).

Heart rate variability: RMSSD during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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).

Fluid consumption during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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).

Fluid loss during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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

Change in plasma volume during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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

Thermal comfort scale during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") ranging from "extremely uncomfortable" to "extremely comfortable"(midpoint: neutral).

Thermal sensation scale during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

Thermal sensation assessed via a visual analog scale ("How hot do you feel?") ranging from "extremely hot" to "neutral"(midpoint: hot)

Thirst sensation scale during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

Thirst sensation scale assessed via a visual analog scale ("How thirsty are you?") ranging from "Very, very thirsty" to "Not thirsty at all" (midpoint: moderately thirsty).

Arousal scale during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

Felt arousal scale assessed via a visual analog scale ("How worked up are you?") ranging from "high arousal" to "low arousal".

Orthostatic intolerance symptoms assessment during daytime

时间窗: End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00)

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".

Core temperature (Peak) during nighttime

时间窗: End of nighttime exposure (hour 24 for Day 1 and Day 2 of the three day exposure; no nighttime exposure for Day 3) (daytime defined as period between 19:00 to 9:00)

Peak rectal temperature (15 min average) during exposure. Rectal temperature is measured continuously throughout the daytime period of the simulated heat wave.

Core temperature (AUC) during nighttime

时间窗: End of nighttime exposure (hour 24 for Day 1 and Day 2 of the three day exposure; no nighttime exposure for Day 3) (daytime defined as period between 19:00 to 9:00)

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

Core temperature end of nighttime

时间窗: End of nighttime exposure (hour 24 for Day 1 and Day 2 of the three day exposure; no nighttime exposure for Day 3) (daytime defined as period between 19:00 to 9:00)

Rectal temperature measured at hour 10 of each daytime exposure to simulated heat wave (15-min average)

Heat rate peak during nighttime

时间窗: End of nighttime exposure (hour 24 for Day 1 and Day 2 of the three day exposure; no nighttime exposure for Day 3) (daytime defined as period between 19:00 to 9:00)

Heart rate during each daytime exposure to simulated heat wave (15-min average)

Heat rate AUC during nighttime

时间窗: End of nighttime exposure (hour 24 for Day 1 and Day 2 of the three day exposure; no nighttime exposure for Day 3) (daytime defined as period between 19:00 to 9:00)

Heart rate measured during each daytime exposure to simulated heat wave (15-min average)

Heart rate variability: SDNN during nighttime

时间窗: End of nighttime exposure (hour 24 for Day 1 and Day 2 of the three day exposure; no nighttime exposure for Day 3) (daytime defined as period between 19:00 to 9:00)

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).

Heart rate variability: RMSSD during nighttime

时间窗: End of nighttime exposure (hour 24 for Day 1 and Day 2 of the three day exposure; no nighttime exposure for Day 3) (daytime defined as period between 19:00 to 9:00)

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).

次要结局

  • Muscle oxygen during battery of cardiovascular, postural and cognitive tests during daytime(End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00))
  • Profiles of Mood States (POMS) during daytime(End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00))
  • Environmental Symptoms Questionnaire (ESQ)(End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00))
  • Sleep quality and quantify assessment(End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00))
  • Sleepiness during daytime(End of daytime exposure (hour 10 for Day 1, 2 and 3 of the three day exposure) (daytime defined as period between 9:00 to 19:00))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Glen P. Kenny

Professor

University of Ottawa

研究点 (2)

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