Thermal DiscomfortNCT06094764
S&B Heat Stress Pilot Protocols
A study testing Group A and Group B in people with Thermal Discomfort, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to develop a heat stress program for the construction industry and evaluate its feasibility and appeal. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thermal Discomfort
- What is being tested?
- Group A and Group B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2023to 23 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- employed at S\&B
- work more than 20 hours a week
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Measuring the Effectiveness of a Personal Cooling Vest for the Prevention of Heat Strain in Construction Workers
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
- Being tested
- Group A, Group B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ADevice
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.
Group BDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Personal monitoring device and a cooling vest , Then personal monitoring device only | Experimental | Not described Receives: Device: Group A |
| Personal monitoring device only, Then personal monitoring device and a cooling vest | Experimental | Not described Receives: Device: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: end of study (about 2 hours after start)
Secondary outcomes (5)
Change in Heart rate as assessed by the Zephyr BioHarness 3.0 device
Measured: from baseline to end of study (2 hours after baseline)
Estimated core body temperature as assessed by the Zephyr BioHarness 3.0 device
Measured: from baseline to end of study (2 hours after baseline)
Respiratory rate as assessed by the Zephyr BioHarness 3.0 device
Measured: from baseline to end of study (2 hours after baseline)
Caloric burn as assessed by the Zephyr BioHarness 3.0 device
Measured: 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
Measured: from baseline to end of study (2 hours after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start22 Jun 2023
- Primary completion23 Jun 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermal DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Principal investigator, William B Perkison, The University of Texas Health Science Center, Houston
- Investigators
- William Perkison, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094764
- Sponsor's protocol ID
- HSC-SPH-22-0651
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effectiveness of a Personal Cooling Vest for the Prevention of Heat Strain in Construction Workers
- ClinicalTrials.gov ID
- NCT06094764
- Acronym / sponsor ID
- HSC-SPH-22-0651
- Conditions
- Thermal Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop a heat stress program for the construction industry and evaluate its feasibility and appeal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- employed at S\&B
- work more than 20 hours a week
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group AThe 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. | Device | Personal monitoring device and a cooling vest , Then personal monitoring device only |
| Group BThe 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. | Device | Personal monitoring device only, Then personal monitoring device and a cooling vest |
Primary outcome
Thermal discomfort as assessed by the thermal comfort scale
Time frame: 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
5 secondary outcomes
Change in Heart rate as assessed by the Zephyr BioHarness 3.0 device
Time frame: from baseline to end of study (2 hours after baseline)
Estimated core body temperature as assessed by the Zephyr BioHarness 3.0 device
Time frame: from baseline to end of study (2 hours after baseline)
Respiratory rate as assessed by the Zephyr BioHarness 3.0 device
Time frame: from baseline to end of study (2 hours after baseline)
Caloric burn as assessed by the Zephyr BioHarness 3.0 device
Time frame: 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
Time frame: from baseline to end of study (2 hours after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Perkison, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with Thermal Discomfort, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal discomfort as assessed by the thermal comfort scale (time frame: end of study (about 2 hours after start)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.