Back to resultsSimulation of Consecutive Day Shift Work
Primary Purpose
Hyperthermia, Fatigue; Heat
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2 days of work heat stress
Sponsored by
About this trial
This is an interventional other trial for Hyperthermia
Eligibility Criteria
Inclusion Criteria:
- 18-39 y old men and women
- Self-reported to be healthy
Exclusion Criteria:
- History of any cardiovascular, neurologic, renal, or metabolic disease
- Current tobacco use or regular use within the last 2 years
- Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.)
- History of exertional heat stroke
- Currently pregnant or breastfeeding, or planning to become pregnant during the study
- Inability to follow the rules of the protocols or understand the consent form
- No contraindications for ingestion of the gastrointestinal temperature pill
Sites / Locations
- Center for Research and Exercise in Special Environments
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Consecutive work
Arm Description
Subjects will complete 2 consecutive days of simulated firefighting tasks in the heat. The simulated work consists of 20 minutes of simulated structural work in a hot environment, followed by 20 minutes of seated rest in a temperate room, mimicking a typical recovery period in structural firefighting. Subjects then re-enter the environmental chamber and complete 23 minutes of simulated overhaul work in a temperate environment.
Outcomes
Primary Outcome Measures
Core temperature
Gastrointestinal temperature measured with an ingestable pill.
Heart rate
Heart rate measured with a wearable heart rate strap and monitor
Secondary Outcome Measures
Full Information
NCT ID
NCT04625634
First Posted
November 6, 2020
Last Updated
July 22, 2022
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT04625634
Brief Title
Simulation of Consecutive Day Shift Work
Official Title
Simulation of Consecutive Day Shift Work
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine differences in physiological recovery between two consecutive days of simulated fire suppression work. The secondary purpose is to determine differences in heat gain and heat loss between two consecutive days of simulated fire suppression work. Subjects will complete two consecutive days of simulated structural firefighting shift work, 24 hours apart. Before and after each laboratory visit, subjects will continuously wear a Holter monitor and ambulatory blood pressure monitor to quantify parasympathetic tone and recovery from work.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthermia, Fatigue; Heat
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Repeated measures study
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Consecutive work
Arm Type
Experimental
Arm Description
Subjects will complete 2 consecutive days of simulated firefighting tasks in the heat. The simulated work consists of 20 minutes of simulated structural work in a hot environment, followed by 20 minutes of seated rest in a temperate room, mimicking a typical recovery period in structural firefighting. Subjects then re-enter the environmental chamber and complete 23 minutes of simulated overhaul work in a temperate environment.
Intervention Type
Other
Intervention Name(s)
2 days of work heat stress
Intervention Description
2 consecutive days of identical simulated structural firefighting tasks.
Primary Outcome Measure Information:
Title
Core temperature
Description
Gastrointestinal temperature measured with an ingestable pill.
Time Frame
20 minutes
Title
Heart rate
Description
Heart rate measured with a wearable heart rate strap and monitor
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-39 y old men and women
Self-reported to be healthy
Exclusion Criteria:
History of any cardiovascular, neurologic, renal, or metabolic disease
Current tobacco use or regular use within the last 2 years
Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.)
History of exertional heat stroke
Currently pregnant or breastfeeding, or planning to become pregnant during the study
Inability to follow the rules of the protocols or understand the consent form
No contraindications for ingestion of the gastrointestinal temperature pill
Facility Information:
Facility Name
Center for Research and Exercise in Special Environments
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual data can be made available upon written request.
Learn more about this trial
Simulation of Consecutive Day Shift Work
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