Protective Cooling Measures to Safeguard Elderly People From Dangerous Summer Heat

University of Ottawa

Status: Not yet enrolling

Conditions: Heat; Weather; Hypertension; Aging; Type2 Diabetes; Heat Stress; Hyperthermia

Treatments: Other: Hybrid cooling; Other: Recommended cooling; Other: No cooling (control)

Study type: Interventional

Funder types: Other

Identifiers

NCT05274009

H-11-21-7566

Details and patient eligibility

About

With the increasing incidence and severity of extreme heat events accompanying climate change, there is an urgent need for sustainable cooling strategies to protect heat-vulnerable older adults, who are at increased risk of adverse health events during heat stress. Health agencies including the World Health Organization, the United States Centers for Disease Control and Prevention, and Health Canada currently recommend visiting a cooling centre or other air-conditioned location for 1-3 hours per day during extreme heat events to mitigate hyperthermia and strain on the cardiovascular system and therefore the risk adverse health events. However, our recent trial shows that while brief air-conditioning exposure is effective for reducing body temperature and cardiovascular burden in healthy older adults, the physiological impacts of cooling abate quickly following return to the heat. The purpose of this project is therefore to assess whether shorter but more frequent air-conditioning exposure provides more effective cooling than current recommendations (a single 1-3-hour cooling bout) in older adults with or without common chronic health conditions associated with increased vulnerability to extreme heat. This will be accomplished by evaluating physiological strain in older adults with and without diabetes and/or hypertension exposed for 8 hours to conditions reflective of extreme heat events in temperate, continental climates (35°C, 60% relative humidity). Participants will complete 3 separate simulated heat event exposures: i) a control trial (no cooling throughout the 8-hour heat event); ii) a recommended cooling trial (3 hours of heat exposure followed by 2 hours cooling); and iii) a hybrid cooling trial (2 hours of heat exposure followed by 1 hour cooling, another 2 hours heat exposure followed by 1 hour cooling, and a final 2-hour heat exposure).

Enrollment: 60 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult aged 60-85 years
• Male or female
• Body mass index < 35 kg/m2
• For participants with type 2 diabetes: at least one year lapsed since diagnosis and hemoglobin A1c 6.0-10.5%.
• For participants with hypertension: at least one year lapsed since diagnosis or average resting blood pressure >140 systolic or >90 diastolic

Exclusion criteria

• Currently smoking or quit <5 years ago
• Moderate or serious medical conditions (other than Type 2 diabetes or high blood pressure), particularly those known to influence physiological responses to heat exposure (e.g., diagnosed heart disease, neurological disorders)
• Heat adapted due to repeated exposure to hot environments (use sauna, recent travel to hot climates, other)
• For participants with type 2 diabetes: "Brittle" diabetes: unpredictable hypo- & hyperglycemia. Severe cardiovascular autonomic or peripheral neuropathy (guidelines.diabetes.ca/cpg)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

60 participants in 3 patient groups

Extreme heat event simulation + no cooling (control)

Experimental group

Description:

Adults aged 60-85 years with or without type 2 diabetes and/or hypertension

Treatment:

Other: No cooling (control)

Extreme heat event simulation + recommended cooling

Experimental group

Description:

Adults aged 60-85 years with or without type 2 diabetes and/or hypertension

Treatment:

Other: Recommended cooling

Extreme heat event simulation + hybrid cooling

Experimental group

Description:

Adults aged 60-85 years with or without type 2 diabetes and/or hypertension

Treatment:

Other: Hybrid cooling