S&B Heat Stress Pilot Protocols

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Completed

CT.gov ID

NCT06094764

Collaborator

National Institute for Occupational Safety and Health (NIOSH/CDC) (U.S. Fed)

Enrollment

Location

Arms

Actual Duration (Days)

426.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to develop a heat stress program for the construction industry and evaluate its feasibility and appeal.

Condition or Disease	Intervention/Treatment	Phase
Thermal Discomfort	Device: Group A Device: Group B	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Measuring the Effectiveness of a Personal Cooling Vest for the Prevention of Heat Strain in Construction Workers

Actual Study Start Date :

Jun 22, 2023

Actual Primary Completion Date :

Jun 23, 2023

Actual Study Completion Date :

Jun 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Personal monitoring device and a cooling vest , Then personal monitoring device only	Device: Group A The intervention will take place after lunch for about 2-3 hours in regular working conditions. Group A will be fitted with a cooling and bio-harness. At the end of each workday, participants will return the monitors and vests will be removed and returned to the research station. The biomonitor's battery will be recharged and data downloaded. The ice vests will be placed in a freezer.
Experimental: Personal monitoring device only, Then personal monitoring device and a cooling vest	Device: Group B The intervention will take place after lunch for about 2-3 hours in regular working conditions. Group B will wear a bio-harness and no cooling vest.At the end of each workday, participants will return the monitors and vests will be removed and returned to the research station. The biomonitor's battery will be recharged and data downloaded. The ice vests will be placed in a freezer.

Arm

Intervention/Treatment

Experimental: Personal monitoring device and a cooling vest , Then personal monitoring device only

Device: Group A

The intervention will take place after lunch for about 2-3 hours in regular working conditions. Group A will be fitted with a cooling and bio-harness. At the end of each workday, participants will return the monitors and vests will be removed and returned to the research station. The biomonitor's battery will be recharged and data downloaded. The ice vests will be placed in a freezer.

Experimental: Personal monitoring device only, Then personal monitoring device and a cooling vest

Device: Group B

The intervention will take place after lunch for about 2-3 hours in regular working conditions. Group B will wear a bio-harness and no cooling vest.At the end of each workday, participants will return the monitors and vests will be removed and returned to the research station. The biomonitor's battery will be recharged and data downloaded. The ice vests will be placed in a freezer.

Outcome Measures

Primary Outcome Measures

Thermal discomfort as assessed by the thermal comfort scale [end of study (about 2 hours after start)]
The thermal comfort scale is a 7-point scale that asks participants to rate their level of thermal comfort ranging from the sensation of "cold, cool, slightly cool, neutral, slightly warm, warm, hot

Secondary Outcome Measures

Change in Heart rate as assessed by the Zephyr BioHarness 3.0 device [from baseline to end of study (2 hours after baseline)]
Estimated core body temperature as assessed by the Zephyr BioHarness 3.0 device [from baseline to end of study (2 hours after baseline)]
Respiratory rate as assessed by the Zephyr BioHarness 3.0 device [from baseline to end of study (2 hours after baseline)]
Caloric burn as assessed by the Zephyr BioHarness 3.0 device [from baseline to end of study (2 hours after baseline)]
Hydration status as indicated by urine specific gravity as assessed by a clinical refractometer analysis of urine sample [from baseline to end of study (2 hours after baseline)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

employed at S&B
work more than 20 hours a week

Exclusion Criteria:

severe chronic disease (e.g. severe pulmonary or cardiovascular disease
history of severe heat stroke
use of a pacemaker
any medical issue which would render the participant unable to wear a chest monitor and cooling vest.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston
National Institute for Occupational Safety and Health (NIOSH/CDC)

Investigators

Principal Investigator: William Perkison, PhD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

William B Perkison, Assistant Professor, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT06094764

Other Study ID Numbers:

HSC-SPH-22-0651

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Oct 23, 2023