S&B Heat Stress Pilot Protocols

NCT06094764 | Completed FDA Device

• 1 other identifier: HSC-SPH-22-0651
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thermal Discomfort

Outcome Measures

Primary Outcomes (1)

• Thermal discomfort as assessed by the thermal comfort scale

  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

  end of study (about 2 hours after start)

Secondary Outcomes (5)

• 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)

Study Arms (2)

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

EXPERIMENTAL

Device: Group A

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

EXPERIMENTAL

Device: Group B

Interventions

Group A DEVICE

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.

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

Group B DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Study Officials

• William Perkison, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: June 22, 2023
• Primary Completion: June 23, 2023
• Study Completion: June 23, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)