NCT04284397

Identification of Critical Thermal Environments for Aged Adults

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Penn State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study evaluates critical environmental limits (temperature and humidity) above which older adults are unable to effectively thermoregulate. Participants will exercise in a series of different environmental conditions to identify combinations of temperature and humidity above which age-related physiological changes cause uncompensable heat stress, resulting in increased risk of heat illness.

Detailed description

The earth's climate is warming well above historical averages, and there is an increased frequency, duration, and severity of heat waves. At the same time, the world's population is rapidly aging. Aging is associated with reductions in thermoregulatory capacity due to reductions in sweating and skin blood flow. For this reason, people ≥65 years exhibit exponentially larger increases in morbidity and mortality during heat waves than younger individuals, with the large majority of excess deaths during heat waves occurring in the elderly. Compounding the physiological effects of primary aging, co-morbidities and common classes of drugs taken by older adults can further compromise their thermoregulatory function. One such class of medications is cyclooxygenase inhibitors, including aspirin (ASA) and other platelet inhibitors. Provocative data published by our lab indicate that platelet inhibitors including ASA increase the rate of heat storage during passive heat stress by \~25%. Following current clinical guidelines, nearly 40% of US adults over the age of 50 engage in an aspirin therapy regiment for the primary or secondary prevention of cardiovascular disease. Although there is compelling evidence that aging is associated with decreased heat dissipation and elevated risk of heat illness in hot ambient conditions, the significant question remains: In what specific environments does this age disparity begin to occur? The goal of the current study is to identify and model ambient conditions that are unsafe for older adults. A second aim of the study is to determine the effects of the commonly used platelet inhibitor, acetylsalicylic acid (ASA), on age-specific critical environmental limits.

Conditions

• Aging

Interventions

Type	Name	Description
DRUG	Low dose ASA	A sub-group of older adults will be re-tested after 7 days of treatment with low-dose aspirin.
OTHER	Control	All participants will be tested with no treatment.

Timeline

• Start date: 2020-12-30
• Primary completion: 2027-02-27
• Completion: 2027-02-27
• First posted: 2020-02-25
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study