Heat Waves and the Elderly With COPD

NCT06295523 | Terminated

• 1 other identifier: STU_2019_1759_COPD
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate thermoregulatory responses in older individuals with COPD.

Conditions

COPD; Aging; Hyperthermia

Keywords

COPD; heat wave; thermoregulation

Outcome Measures

Primary Outcomes (4)

• Core body temperature

  Core body temperature will be measure from gastrointestinal temperature via an ingestible telemetric pill

  Prior to and throughout each simulated heat wave exposure, an average of 480 minutes

• Forced expiratory volume (FEV1)

  FEV1 will be assessed via spirometry

  Prior to, during, and after each simulated heat wave exposure, approximately 10 min each

• Forced vital capacity (FVC)

  FVC will be assessed via spirometry

  Prior to, during, and after each simulated heat wave exposure, approximately 10 min each

• FEV1/FVC ratio

  The ratio of forced expiratory volume and forced vital capacity will be assessed via spirometry

  Prior to, during, and after each simulated heat wave exposure, approximately 10 min each

Study Arms (2)

Experimental: Very hot and dry

EXPERIMENTAL

Subjects will be exposed to 3 hours in a climate chamber set to approximately 47 deg C and 15% relative humidity, which reflects a very hot and dry heat wave condition similar to the 2018 Los Angeles heat wave. Two visits will be required to complete this arm, with one visit including water spray for cooling.

Other: Water Spray; Other: Control

Experimental: Hot and humid

EXPERIMENTAL

Subjects will be exposed to 3 hours in a climate chamber set to approximately 41 deg C and 40% relative humidity, which reflects hot and humid heat wave similar to the 1995 Chicago heat wave. Two visits will be required to complete this arm, with one visit including water spray for cooling.

Other: Water Spray; Other: Control

Interventions

Water Spray OTHER

Participants will receive water spraying on their body throughout the climate chamber exposure.

Experimental: Hot and humid; Experimental: Very hot and dry

Control OTHER

Participants will NOT receive water spraying on their body throughout the climate exposure.

Experimental: Hot and humid; Experimental: Very hot and dry

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years old or older
• Diagnosis of COPD

You may not qualify if:

• Known heart disease
• Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia etc
• Abnormality detected on routine screening suggestive of provokable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram
• Current smokers
• Participant with a body mass index ≥31 kg/m2

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• American Heart Association: collaborator

Study Sites (1)

Texas Health Presbyterian Hospital Dallas

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hyperthermia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 6, 2024
• Study Start: January 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)