Environmental Temperatures for Work of Breathing

TD
Overseen ByTimothy D Mickleborough, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different temperatures affect breathing and thinking when increased breathing effort is required, such as when using certain military equipment. Participants will breathe through a device that restricts airflow while experiencing normal, hot, and cold temperatures. This exposure to varying temperatures is called "Thermal Stress Exposure." The goal is to determine if temperature changes impact breathing or cognitive clarity. Ideal candidates for the trial exercise intensely for at least 120 minutes weekly, have normal lung and cognitive function, and have no history of smoking or specific health conditions. As an unphased trial, this study allows participants to contribute to foundational research that could enhance safety and performance in challenging environments.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, including selective serotonin reuptake inhibitors, stimulant medication, antibiotics, and chronic pain medications like Aleve and Tylenol, to participate in this trial.

What prior data suggests that thermal stress exposure is safe for participants?

Research shows that extreme temperatures can affect the body, particularly breathing and overall health. Studies have found that heat can impair lung function and increase the risk of breathing problems. For instance, one study discovered that heat exposure could harm lung function. This means lungs might not work as well in hot conditions.

Heat can also lead to more serious health issues. It has been linked to increased hospital visits for breathing problems and can sometimes result in severe conditions like heat-related illnesses.

While this study examines the effects of extreme temperatures, extensive research has explored this topic. Scientists use these findings to better understand potential risks. If there are any concerns, consulting a healthcare professional before joining a trial is advisable.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different environmental temperatures impact the work of breathing. Unlike typical treatments that focus on medication or devices to assist breathing, this trial investigates how thermal stress—exposure to varying temperatures—affects respiratory function. By studying the effects of cold, thermoneutral, and hot temperatures on breathing, the trial aims to uncover new insights that could lead to innovative ways to manage respiratory conditions. Understanding these interactions could pave the way for non-invasive methods to support patients with breathing difficulties.

What evidence suggests that thermal stress exposure is effective for altering breathing perception and cognitive performance?

This trial will evaluate how different environmental temperatures affect breathing and cognitive function. Research has shown that hot environments can impair both breathing and clear thinking. Studies have found that high temperatures reduce lung function and make breathing more difficult. Heat increases body temperature and heart rate, which complicates breathing. Additionally, exposure to heat has been linked to slower thinking and reduced accuracy in tasks requiring focus. These findings suggest that heat can impact both breathing and mental sharpness, especially in challenging situations. Participants in this trial will experience various temperature conditions to assess these effects.26789

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-40 who exercise intensely at least 2 hours a week, have normal lung and cognitive function, and meet certain health criteria. People with heart, lung, kidney, nerve or metabolic diseases; smokers; those on specific medications; pregnant women; and those with irregular menstrual cycles cannot join.

Inclusion Criteria

English speaking and reading
Normal cognitive function assessed using the Montreal cognitive function test [18]
I am between 18 and 40 years old.
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Exclusion Criteria

History of smoking or recreational smoking, cardiovascular disease, renal disease, pulmonary disease (including asthma or exercise-induced asthma), neurological disease, and metabolic disease
Are pregnant or could possibly be pregnant by self-report
Are color blind
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Timeline for a Trial Participant

Screening/Familiarization

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Experimental Visits

Participants complete breathing tasks under different temperature conditions (thermoneutral, heat, cold) with cognitive and physiological assessments

3 days (with 7-day washout between visits)
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after experimental visits

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Thermal Stress Exposure

Trial Overview

The study tests how different temperatures (normal, hot, cold) affect breathing effort and thinking skills when it's harder to breathe in. Participants will perform tasks under each temperature condition to see if heat or cold makes breathing feel harder or affects mental performance.

How Is the Trial Designed?

6

Treatment groups

Active Control

Group I: Thermoneutral temperature, then Cold temperature, then Hot temperatureActive Control3 Interventions
Group II: Thermoneutral temperature, then Hold temperature, then Cot temperatureActive Control3 Interventions
Group III: Cold temperature, then Thermoneutral temperature, then Hot temperatureActive Control3 Interventions
Group IV: Cold temperature, then Hot temperature, then Thermoneutral temperatureActive Control3 Interventions
Group V: Hot temperature, then Thermoneutral temperature, then Cold temperatureActive Control3 Interventions
Group VI: Hot temperature, then Cold temperature, then Thermoneutral temperatureActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Citations

A systematic review and meta-analysis of the impact ...

The meta-analyses findings show that exposure to high temperatures is associated with an elevated risk of cardiovascular morbidity and mortality, with morbidity ...

Effects of Acute Exposure to Thermal Stress on ... - PMC - NIH

Acute thermal stress induces a decrease in exercise performance via increased body temperature, HR, VE, and blood lactate levels and decreased oxygen pulse.

Association between ambient temperature and respiratory ...

Key findings. • Short- and long-term heat exposure were associated with lung function decline, with the greatest effects at higher temperatures.

Heat and health

Heat stress is a leading cause of weather-related deaths and can exacerbate underlying illnesses including cardiovascular disease, diabetes, ...

Occupational Exposure to Heat and Hot Environments

Occupational exposure to heat can result in injuries, disease, reduced productivity, and death. To address this hazard, the National Institute for Occupational ...

Occupational heat stress, heat-related effects and the ... - PMC

Heat exposure had a significant direct effect on the productivity outcomes of mining worker. This effect was moderated by barriers to adaptation strategies, ...

Extreme Heat Is More Dangerous for Workers Every Year

In 2022, the U.S. Bureau of Labor Statistics reported 51 fatalities due to exposure to extreme temperatures and approximately 43 of those deaths ...

Impact of Heat on Respiratory Hospitalizations among Older ...

During the 18-year study period, there were an estimated 11,710 excess respiratory hospitalizations due to heat exposure. Conclusions: Results ...

Heat Exposure Changes Lung Function, Biomarkers of Airway ...

In summary, acute heat exposure was associated with reductions in lung function and airway injury. Potential biological mechanisms may involve lung epithelial ...