Initial Stay Times and Heat Mitigation Controls for Uncompensable Occupational Heat Stress - Part I

August 4, 2024 updated by: Glen P. Kenny, University of Ottawa

Safe Maximum Work Times and the Effectiveness of Work-rest Allocations in Mitigating Increases in Core Temperature During and on the Day Following Prolonged Moderate-intensity Work in the Heat in Young and Older Workers

Workplaces rely on upper heat stress limits provided by the American Conference of Governmental Industrial Hygienists (ACGIH) to manage the health and safety of workers in hot environments. This is primarily achieved by interspersing work with rest periods, the length of which is dictated by environmental conditions and work intensity, to maintain core temperature at or below 38.0°C (equivalent to a 1°C increase in body core temperature above resting levels). However, these guidelines employ a "one size fits all" approach to exposure limits that does not consider individual variation between workers. Moreover, they fail to provide direction on the safe, initial stay times before these heat-mitigation controls should be employed (i.e., rest breaks) in conditions exceeding upper heat stress limits. While recent work has generated estimates of the initial stay times for young to older men before heat-mitigation controls are required for moderate-intensity work, this information is limited to a single work bout and does not consider a second work bout preceded by an extended rest period (e.g., lunch) or next day effects. This is a key consideration, as prolonged work in the heat has been shown to cause next-day impairments in heat dissipation in older men. Further, it remains unclear if the application of the prescribed ACGIH work-rest allocations thereafter would alleviate increases in core temperature for the duration of the work period (e.g., start of shift versus post-lunch period). This project will address these knowledge gaps by determining if refinements in initial stay times for moderate-intensity work (represents the average work effort of physically demanding occupations) in the heat (26°C wet-bulb globe temperature) may be required for young and older adults for i) a second work bout that is preceded by an extended rest period such as a lunch break, and ii) a work bout performed on the next day. This includes assessing the efficacy of the prescribed ACGIH work-rest allocations to mitigate increases in core temperature beyond safe limits (>38.0°C, equivalent to a >1°C increase in body core temperature above resting levels) during these work periods. Given the known sex-differences in heat loss that can modulate core temperature regulation during an exercise-heat stress, the investigators will conduct separate analysis to identify modulating effects of biological sex on the initial stay times and effectiveness of the work-rest allocation as a heat-alleviation control.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1N6N5
        • University of Ottawa

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • young (18-30 years) and older adults (50-69 years)
  • habitually active, not endurance trained (<2 sessions per week, <150 minutes per week)
  • non-smoking
  • English or French speaking
  • ability to provide informed consent

Exclusion Criteria:

  • pre-existing health conditions (e.g., diabetes, hypertension)
  • use of medication deemed to significantly modulate thermoregulatory function and heat tolerance (e.g., antidepressants, antihistamines, diuretics)
  • engaged in jobs and/or activities that involve frequent exposure to hot environments (e.g., regular sauna use)

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Younger adults
Adults aged 18-30 years with no pre-existing health conditions
Other: Simulated work in the heat
Participants perform a continuous moderate-intensity work bout (metabolic rate of ~200 W/m2) until core temperature reaches 38.0°C (equivalent to a 1°C increase in body core temperature above resting levels), which is immediately followed by intermittent work using a 3:1 work-rest allocation, starting with a 15 min rest break followed by a 45 min work bout for a total work duration of ~240 min. The work protocol is performed in the morning of day 1, and repeated in a post-lunch work period (i.e., afternoon of day 1) and on the morning of the next day (i.e., morning of day 2).
Experimental: Older adults
Adults aged 50-69 with no pre-existing health conditions
Other: Simulated work in the heat
Participants perform a continuous moderate-intensity work bout (metabolic rate of ~200 W/m2) until core temperature reaches 38.0°C (equivalent to a 1°C increase in body core temperature above resting levels), which is immediately followed by intermittent work using a 3:1 work-rest allocation, starting with a 15 min rest break followed by a 45 min work bout for a total work duration of ~240 min. The work protocol is performed in the morning of day 1, and repeated in a post-lunch work period (i.e., afternoon of day 1) and on the morning of the next day (i.e., morning of day 2).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Initial stay time
Time Frame: End of first (morning day 1) continuous work bout
Total continuous work time to achieve an initial absolute increase in core temperature of 38°C (equivalent to a 1°C increase in body core temperature above resting levels) (note: in instances where a participant voluntarily terminates work prematurely before the absolute core temperature of ≥38°C (or relative increase of ≥1°C) is achieved or the absolute core temperature is <38°C (or relative increase of <1°C), the time of termination or end of the work bout will be taken as the initial stay time respectively).
End of first (morning day 1) continuous work bout
Initial stay time
Time Frame: End of second (afternoon day 1) continuous work bout
Total continuous work time to achieve an initial absolute increase in core temperature of 38°C (equivalent to a 1°C increase in body core temperature above resting levels) (note: in instances where a participant voluntarily terminates work prematurely before the absolute core temperature of ≥38°C (or relative increase of ≥1°C) is achieved or the absolute core temperature is <38°C (or relative increase of <1°C), the time of termination or end of the work bout will be taken as the initial stay time respectively).
End of second (afternoon day 1) continuous work bout
Initial stay time
Time Frame: End of third (morning day 2) continuous work bout
Total continuous work time to achieve an initial absolute increase in core temperature of 38°C (equivalent to a 1°C increase in body core temperature above resting levels) (note: in instances where a participant voluntarily terminates work prematurely before the absolute core temperature of ≥38°C (or relative increase of ≥1°C) is achieved or the absolute core temperature is <38°C (or relative increase of <1°C), the time of termination or end of the work bout will be taken as the initial stay time respectively).
End of third (morning day 2) continuous work bout
Average core temperature
Time Frame: Period of work-rest allocations following initial stay time for morning day 1
Average core temperature over final 2-hours of each work bout
Period of work-rest allocations following initial stay time for morning day 1
Average core temperature
Time Frame: Period of work-rest allocations following initial stay time for afternoon day 1
Average core temperature following initial stay time
Period of work-rest allocations following initial stay time for afternoon day 1
Average core temperature
Time Frame: Period of work-rest allocations following initial stay time for morning day 2
Average core temperature following initial stay time
Period of work-rest allocations following initial stay time for morning day 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: End of first (morning day 1) work period
Arterial blood pressure measured via automated oscillometry
End of first (morning day 1) work period
Systolic blood pressure
Time Frame: End of second (afternoon day 1) work period
Arterial blood pressure measured via automated oscillometry
End of second (afternoon day 1) work period
Systolic blood pressure
Time Frame: End of third (morning day 2) work period
Arterial blood pressure measured via automated oscillometry
End of third (morning day 2) work period
Diastolic blood pressure
Time Frame: End of first (morning day 1) work period
Arterial blood pressure measured via automated oscillometry
End of first (morning day 1) work period
Diastolic blood pressure
Time Frame: End of second (afternoon day 1) work period
Arterial blood pressure measured via automated oscillometry
End of second (afternoon day 1) work period
Diastolic blood pressure
Time Frame: End of third (morning day 2) work period
Arterial blood pressure measured via automated oscillometry
End of third (morning day 2) work period
Mean arterial blood pressure
Time Frame: End of first (morning day 1) work period
Calculated as 1/3 * systolic blood pressure + 2/3 * diastolic blood pressure
End of first (morning day 1) work period
Mean arterial blood pressure
Time Frame: End of second (afternoon day 1) work period
Calculated as 1/3 * systolic blood pressure + 2/3 * diastolic blood pressure
End of second (afternoon day 1) work period
Mean arterial blood pressure
Time Frame: End of third (morning day 2) work period
Calculated as 1/3 * systolic blood pressure + 2/3 * diastolic blood pressure
End of third (morning day 2) work period
Rate pressure product
Time Frame: End of first (morning day 1) work period
Calculated as systolic blood pressure * heart rate
End of first (morning day 1) work period
Rate pressure product
Time Frame: End of second (afternoon day 1) work period
Calculated as systolic blood pressure * heart rate
End of second (afternoon day 1) work period
Rate pressure product
Time Frame: End of third (morning day 2) work period
Calculated as systolic blood pressure * heart rate
End of third (morning day 2) work period
Fluid consumption
Time Frame: End of first (morning day 1) work period
Cumulative fluid consumption calculated by weighing the participant's water intake
End of first (morning day 1) work period
Fluid consumption
Time Frame: End of second (afternoon day 1) work period
Cumulative fluid consumption calculated by weighing the participant's water intake
End of second (afternoon day 1) work period
Fluid consumption
Time Frame: End of third (morning day 2) work period
Cumulative fluid consumption calculated by weighing the participant's water intake
End of third (morning day 2) work period
Fluid loss
Time Frame: End of first (morning day 1) work period
Fluid loss calculated as the change in body mass (corrected for food/fluid consumption).
End of first (morning day 1) work period
Fluid loss
Time Frame: End of second (afternoon day 1) work period
Fluid loss calculated as the change in body mass (corrected for food/fluid consumption).
End of second (afternoon day 1) work period
Fluid loss
Time Frame: End of third (morning day 2) work period
Fluid loss calculated as the change in body mass (corrected for food/fluid consumption).
End of third (morning day 2) work period
Change in plasma volume
Time Frame: End of first (morning day 1) work period
Determined from venous blood samples
End of first (morning day 1) work period
Change in plasma volume
Time Frame: End of second (afternoon day 1) work period
Determined from venous blood samples
End of second (afternoon day 1) work period
Change in plasma volume
Time Frame: End of third (morning day 2) work period
Determined from venous blood samples
End of third (morning day 2) work period
Thermal comfort scale
Time Frame: End of first (morning day 1) continuous work bout
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
End of first (morning day 1) continuous work bout
Thermal comfort scale
Time Frame: End of second (afternoon day 1) continuous work bout
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
End of second (afternoon day 1) continuous work bout
Thermal comfort scale
Time Frame: End of third (morning day 2) continuous work bout
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
End of third (morning day 2) continuous work bout
Thirst sensation scale
Time Frame: End of first (morning day 1) continuous work bout
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
End of first (morning day 1) continuous work bout
Thirst sensation scale
Time Frame: End of second (afternoon day 1) continuous work bout
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
End of second (afternoon day 1) continuous work bout
Thirst sensation scale
Time Frame: End of third (morning day 2) continuous work bout
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
End of third (morning day 2) continuous work bout
Rating of Perceived Exertion
Time Frame: End of first (morning day 1) continuous work bout
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
End of first (morning day 1) continuous work bout
Rating of Perceived Exertion
Time Frame: End of second (afternoon day 1) continuous work bout
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
End of second (afternoon day 1) continuous work bout
Rating of Perceived Exertion
Time Frame: End of third (morning day 2) continuous work bout
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
End of third (morning day 2) continuous work bout
Orthostatic Intolerance Symptoms Assessment
Time Frame: End of first (morning day 1) continuous work bout
Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance. All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort".
End of first (morning day 1) continuous work bout
Orthostatic Intolerance Symptoms Assessment
Time Frame: End of second (afternoon day 1) continuous work bout
Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance. All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort".
End of second (afternoon day 1) continuous work bout
Orthostatic Intolerance Symptoms Assessment
Time Frame: End of third (morning day 2) continuous work bout
Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance. All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort".
End of third (morning day 2) continuous work bout
Heart rate at initial stay time
Time Frame: End of first (morning day 1) continuous work bout
Heart rate at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
End of first (morning day 1) continuous work bout
Heart rate at initial stay time
Time Frame: End of second (afternoon day 1) continuous work bout
Heart rate at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
End of second (afternoon day 1) continuous work bout
Heart rate at initial stay time
Time Frame: End of third (morning day 2) continuous work bout
Heart rate at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
End of third (morning day 2) continuous work bout
Skin temperature at initial stay time
Time Frame: End of first (morning day 1) continuous work bout
Skin temperature (4 sites) measured at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
End of first (morning day 1) continuous work bout
Skin temperature at initial stay time
Time Frame: End of second (afternoon day 1) continuous work bout
Skin temperature (4 sites) measured at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
End of second (afternoon day 1) continuous work bout
Skin temperature at initial stay time
Time Frame: End of third (morning day 2) continuous work bout
Skin temperature (4 sites) measured at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
End of third (morning day 2) continuous work bout
Average heart rate
Time Frame: Period of work-rest allocations following initial stay time for morning day 1
Average heart rate following initial stay time
Period of work-rest allocations following initial stay time for morning day 1
Average heart rate
Time Frame: Period of work-rest allocations following initial stay time for afternoon day 1
Average heart rate following initial stay time
Period of work-rest allocations following initial stay time for afternoon day 1
Average heart rate
Time Frame: Period of work-rest allocations following initial stay time for morning day 2
Average heart rate following initial stay time
Period of work-rest allocations following initial stay time for morning day 2
Average skin temperature
Time Frame: Period of work-rest allocations following initial stay time for morning day 1
Average skin temperatures following initial stay time
Period of work-rest allocations following initial stay time for morning day 1
Average skin temperature
Time Frame: Period of work-rest allocations following initial stay time for afternoon day 1
Average skin temperatures following initial stay time
Period of work-rest allocations following initial stay time for afternoon day 1
Average skin temperature
Time Frame: Period of work-rest allocations following initial stay time for morning day 2
Average skin temperatures following initial stay time
Period of work-rest allocations following initial stay time for morning day 2
Thermal comfort scale
Time Frame: Period of work-rest allocations following initial stay time for morning day 1
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
Period of work-rest allocations following initial stay time for morning day 1
Thermal comfort scale
Time Frame: Period of work-rest allocations following initial stay time for afternoon day 1
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
Period of work-rest allocations following initial stay time for afternoon day 1
Thermal comfort scale
Time Frame: Period of work-rest allocations following initial stay time for morning day 2
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
Period of work-rest allocations following initial stay time for morning day 2
Thirst sensation scale
Time Frame: Period of work-rest allocations following initial stay time for morning day 1
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
Period of work-rest allocations following initial stay time for morning day 1
Thirst sensation scale
Time Frame: Period of work-rest allocations following initial stay time for afternoon day 2
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
Period of work-rest allocations following initial stay time for afternoon day 2
Thirst sensation scale
Time Frame: Period of work-rest allocations following initial stay time for morning day 2
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
Period of work-rest allocations following initial stay time for morning day 2
Rating of Perceived Exertion
Time Frame: Period of work-rest allocations following initial stay time for morning day 1
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
Period of work-rest allocations following initial stay time for morning day 1
Rating of Perceived Exertion
Time Frame: Period of work-rest allocations following initial stay time for afternoon day 2
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
Period of work-rest allocations following initial stay time for afternoon day 2
Rating of Perceived Exertion
Time Frame: Period of work-rest allocations following initial stay time for morning day 2
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
Period of work-rest allocations following initial stay time for morning day 2
Orthostatic Intolerance Symptoms Assessment
Time Frame: Period of work-rest allocations following initial stay time for morning day 1
Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance. All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort".
Period of work-rest allocations following initial stay time for morning day 1
Orthostatic Intolerance Symptoms Assessment
Time Frame: Period of work-rest allocations following initial stay time for afternoon day 1
Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance. All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort".
Period of work-rest allocations following initial stay time for afternoon day 1
Orthostatic Intolerance Symptoms Assessment
Time Frame: Period of work-rest allocations following initial stay time for morning day 2
Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance. All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort".
Period of work-rest allocations following initial stay time for morning day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ottawa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Glen P Kenny, PhD, University of Ottawa

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HEPRU 2023-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified participant data will be made available with approved analysis plan and signed access agreement

IPD Sharing Time Frame

Following publication of the main study report(s)

IPD Sharing Access Criteria

Approved analysis plan and signed access agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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