- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04625634
Simulation of Consecutive Day Shift Work
July 22, 2022 updated by: Riana Pryor, State University of New York at Buffalo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Buffalo, New York, United States, 14214
- Center for Research and Exercise in Special Environments
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Consecutive work
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.
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2 consecutive days of identical simulated structural firefighting tasks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Core temperature
Time Frame: 20 minutes
|
Gastrointestinal temperature measured with an ingestable pill.
|
20 minutes
|
Heart rate
Time Frame: 20 minutes
|
Heart rate measured with a wearable heart rate strap and monitor
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20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 2, 2019
Primary Completion (Actual)
May 1, 2022
Study Completion (Actual)
May 1, 2022
Study Registration Dates
First Submitted
November 6, 2020
First Submitted That Met QC Criteria
November 6, 2020
First Posted (Actual)
November 12, 2020
Study Record Updates
Last Update Posted (Actual)
July 26, 2022
Last Update Submitted That Met QC Criteria
July 22, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003948
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual data can be made available upon written request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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