Heat StressNCT04160741
Effects of Solar Radiation on Human Function and Cognition
A study testing Radiation and warm environment, Warm environment and Neutral environment with radiation in people with Heat Stress and Heat Strain, run by Petros Dinas at 1 site in Greece.
Trial summary
Solar radiation is a physical phenomenon which interacts with any human being throughout its life on earth. This interaction is associated with numerous physiological functions, as well as a broad spectrum of deleterious effects on human health and wellbeing. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heat Stress, Heat Strain
- What is being tested?
- Radiation and warm environment, Warm environment and Neutral environment with radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteGreece
- Study dates
- 15 Feb 2019to 27 May 2019
- 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 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy non-smoker individuals who exercise at least three times per week
Who cannot join
- Non healthy individuals and smokers
Trial locations and contacts
1 site in 1 country.
Greece1 site
FAME Lab, Department of Exercise Science, University of Thessaly
Trikala, Thessaly, 42100
About this study
Solar radiation is a physical phenomenon which interacts with any human being throughout its life on earth. This interaction is associated with numerous physiological functions, as well as a broad spectrum of deleterious effects on human health and wellbeing. The aim of this study is to elucidate the effects of solar radiation on human function and cognition in environmental conditions characterized by the same thermal stress.
Read the detailed description
Volunteers were exposed to four different environmental conditions [two hot environments: 30°C WBGT (1st: air temperature = 32.6°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 800 W/m2 and 2nd. air temperature = 40.6°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 0 W/m2) and two neutral environments: 20°C WBGT (1st: air temperature = 19.1°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 800 W/m2 and 2nd. air temperature = 28.5°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 0 W/m2], over an equal number of days. The aforementioned environmental scenarios were randomly allocated for each volunteer. To minimize participant bias, the true purpose of the study was hidden from the volunteers. Of course, once the data collection was completed, all volunteers were informed about the true purpose of the study and gave their permission to analyze and publish these data. During this blinded randomized controlled trial, all volunteers participated four times in an experimental protocol with a total duration of 03:20:00, following an hour of preparation and baseline tests. The protocol had three main time periods [rest (two hours), work (cycling) at 100 W (one hour), and recovery (twenty minutes)]. Anthropometrical data [age; body stature (Seca 213; seca GmbH \& Co. KG; Hamburg, Germany); body mass (BC1000, Tanita corporation, Tokyo, Japan); body fat (DXA scan: Lunar DPX Madison, GE Healthcare, Wisconsin, USA); and lean mass (DXA scan: Lunar DPX Madison, GE Healthcare, Wisconsin, USA)] were collected two days prior to the experiments.
Volunteers were euhydrated prior to the experiments. Hydration status was assessed using a handheld refractometer (ATAGO Ltd, Tokyo, Japan) and determined as either euhydrated (USG < 1.020) or dehydrated (USG ≥ 1.020) according to the current guidelines. Water consumption was restricted during the experimental protocol. The same clothing consisting of a light-blue t-shirt (100% cotton), a black exercise short pant (100% polyester), and a pair of medium-high socks (100% cotton) were used by volunteers throughout the experiments. A pair of sunglasses was mandatory to be worn throughout the experiments. Furthermore, experiments took place during the same hour of the day for each participant and an 8-hour fasting was ensured prior to the experiments. Furthermore, participants were requested to avoid caffeine and alcohol consumption for at least twelve hours before the experiments, as well as to avoid salt and sugar consumption eight hours before the experiments.
During the study, continuous heart rate, core temperature, mean skin temperature, skin blood flow, and sweat rate were measured. Specifically, heart rate was collected using wireless heart rate monitors (Polar Team2. Polar Electro Oy, Kempele, Finland). Core temperature was collected using telemetric capsules (BodyCap, Caen, France). Skin temperature from four sites was measured using wireless thermistors (iButtons type DS1921H, Maxim/Dallas Semiconductor Corp., USA) and was expressed as mean skin temperature according to Ramanathan [mean skin temperature = 0.3(chest + arm) + 0.2(thigh + leg). Skin blood flow was measured with a laser Doppler flowmeter (PeriFlux 4000, Perimed, Stockholm, Sweden) at right forearm (brachioradialis) and leg (gastrocnemius). The probe (PROBE 413 Integrating Probe, Perimed, Stockhold, Sweden) was held in place with a plastic holder (PH 13, Perimed, Stockhold, Sweden). Sweat rate was measured at three regions [forehead, thigh (quadricep), and arm (bicep)] using ventilated capsule method. Thermal comfort (1 = comfortable; 5 = extremely uncomfortable), thermal sensation (-3 = cold; +3 = hot), and perceived exertion (6 = no exertion at all; 20 = maximal exertion), alongside cognitive performance (vigilance, divided attention, memory test, and reaction time) were assessed at baseline, pre work condition (01:40:00), and post work (03:00:00) conditions. Volunteers entered the chamber five minutes prior to the experiments to install data loggers and accompanied sensors on their body.
- Conditions
- Heat Stress, Heat Strain
- Being tested
- Radiation and warm environment, Warm environment, Neutral environment with radiation, Neutral environment without radiation
- Keywords
- heat stress, heat strain, solar radiation, responses, cognition, thermal
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation and warm environmentOther
Exposure to hot environment (30°C WBGT) with radiation (800 W/m2)
Exposure for 03:20:00:
- rest (two hours)
- work (cycling) at 100 W (one hour)
- recovery (twenty minutes)
Warm environmentOther
Exposure to hot environment (30°C WBGT) with radiation (0 W/m2)
Exposure for 03:20:00:
- rest (two hours)
- work (cycling) at 100 W (one hour)
- recovery (twenty minutes)
Neutral environment with radiationRadiation
Exposure to neutral environment (20°C WBGT) with radiation (800 W/m2)
Exposure for 03:20:00:
- rest (two hours)
- work (cycling) at 100 W (one hour)
- recovery (twenty minutes)
Neutral environment without radiationOther
Exposure to neutral environment (20°C WBGT) with radiation (0 W/m2)
Exposure for 03:20:00:
- rest (two hours)
- work (cycling) at 100 W (one hour)
- recovery (twenty minutes)
| Study group | Role | What they receive |
|---|---|---|
| Hot environment with radiation | Experimental | Exposure to hot environment (30°C WBGT) with radiation (800 W/m2)
Exposure for 03:20:00:
* rest (two hours)
* work (cycling) at 100 W (one hour)
* recovery (twenty minutes) Receives: Other: Radiation and warm environment |
| Hot environment without radiation | Experimental | Exposure to hot environment (30°C WBGT) with radiation (0 W/m2)
Exposure for 03:20:00:
* rest (two hours)
* work (cycling) at 100 W (one hour)
* recovery (twenty minutes) Receives: Other: Warm environment |
| Neutral environment with radiation | Experimental | Exposure to neutral environment (20°C WBGT) with radiation (800 W/m2)
Exposure for 03:20:00:
* rest (two hours)
* work (cycling) at 100 W (one hour)
* recovery (twenty minutes) Receives: Radiation: Neutral environment with radiation |
| Neutral environment without radiation | Active comparator | Exposure to neutral environment (20°C WBGT) with radiation (0 W/m2)
Exposure for 03:20:00:
* rest (two hours)
* work (cycling) at 100 W (one hour)
* recovery (twenty minutes) Receives: Other: Neutral environment without radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate data were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
Measured: 03 hours and 20 minutes
Mean skin temperature
Temperature at the skin surface area was continuously monitored using iButton sensors (type DS1921 H, Maxim/Dallas Semiconductor Corp., USA)
Measured: 03 hours and 20 minutes
Core body temperature
Core body temperature was assessed throughout the entire protocol using telemetric capsules (e-Celsius, BodyCap, Caen, France) that was given to the workers to ingest prior to their work shift
Measured: 03 hours and 20 minutes
Skin blood flow
Skin blood flow was measured throughout the entire protocol with a laser Doppler flowmeter (PeriFlux 4000, Perimed, Stockholm, Sweden) at right forearm (brachioradialis) and leg (gastrocnemius)
Measured: 03 hours and 20 minutes
Sweat rate
Sweat rate was measured throughout the entire protocol at three regions [forehead, thigh (quadricep), and arm (bicep)] using ventilated capsule method
Measured: 03 hours and 20 minutes
Perceived exertion
We used the Borg 20th Scale (6 = no exertion at all; 20 = maximal exertion)
Measured: Participants were assessed at baseline and every half an hour up until the end of the protocol at "hour 3".
Cognitive performance (Vigilance)
Vigilance was assessed via vigilance test. In this task two squares arranged vertically. A pattern jumps from one square to the other. Sometimes the pattern remains in one square. In this case volunteers had to touch the screen of a tablet computer as fast as possible. The total duration for the current task was set to 6 minutes. This is a well-known vigilance test described in the Test for Attentional Performance and previously used in the literature.
Measured: Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".
Thermal comfort
Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable).
Measured: Participants were assessed at baseline and every half an hour up until the end of the protocol at "hour 3".
Thermal sensation
Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)
Measured: Participants were assessed at baseline and every half an hour up until the end of the protocol at "hour 3".
Cognitive performance (Divided Attention)
Divided attention task incorporates both auditory and visual stimuli in parallel. During the test a number of visual stimuli (crosses) appear in a random configuration in a 4X4 matrix. At the same time volunteers hear high and low beeps in a random order. The task is to detect whether crosses form a square and at the same time two high or low beeps are emitted twice in a row. This is a well-known vigilance test described in the Test for Attentional Performance and previously used in the literature.
Measured: Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".
Cognitive performance (Memory Test)
This is a computerized version of Sternberg's memory task. In this task volunteers had to observe carefully a random sequence of one to six digits (0 to 9) painted in white and displayed for 1.2 seconds each. Thereafter, a two second delay was followed by a random test digit filled in yellow color. Participants had to response as fast as possible by pressing "yes" or "no" button to indicate where the yellow digit appeared in the previous sequence or not, respectively. In this test participants were tested in 24 trials.
Measured: Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".
Cognitive performance (Reaction Time)
In this task participants had to respond as quickly as possible, by untouching the screen, after receiving a visual or acoustic stimulus.
Measured: Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start15 Feb 2019
- Primary completion27 May 2019
- Study completion27 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StressStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petros Dinas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Petros Dinas, University of Thessaly
- Investigators
- Andreas Flouris, Principal investigator, andreasflouris@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160741
- Sponsor's protocol ID
- 6. Solar radiation & Thermo
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2019
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Solar Radiation on Human Function and Cognition
- ClinicalTrials.gov ID
- NCT04160741
- Acronym / sponsor ID
- 6. Solar radiation & Thermo
- Conditions
- Heat Stress, Heat Strain
- Keywords
- heat stress, heat strain, solar radiation, responses, cognition, thermal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Petros DinasUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 27 May 2019 (actual)
- Study completion
- 27 May 2019 (actual)
- First posted
- 13 Nov 2019 (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.
Solar radiation is a physical phenomenon which interacts with any human being throughout its life on earth. This interaction is associated with numerous physiological functions, as well as a broad spectrum of deleterious effects on human health and wellbeing. The aim of this study is to elucidate the effects of solar radiation on human function and cognition in environmental conditions characterized by the same thermal stress.
Detailed description
Volunteers were exposed to four different environmental conditions [two hot environments: 30°C WBGT (1st: air temperature = 32.6°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 800 W/m2 and 2nd. air temperature = 40.6°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 0 W/m2) and two neutral environments: 20°C WBGT (1st: air temperature = 19.1°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 800 W/m2 and 2nd. air temperature = 28.5°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 0 W/m2], over an equal number of days. The aforementioned environmental scenarios were randomly allocated for each volunteer. To minimize participant bias, the true purpose of the study was hidden from the volunteers. Of course, once the data collection was completed, all volunteers were informed about the true purpose of the study and gave their permission to analyze and publish these data. During this blinded randomized controlled trial, all volunteers participated four times in an experimental protocol with a total duration of 03:20:00, following an hour of preparation and baseline tests. The protocol had three main time periods [rest (two hours), work (cycling) at 100 W (one hour), and recovery (twenty minutes)]. Anthropometrical data [age; body stature (Seca 213; seca GmbH \& Co. KG; Hamburg, Germany); body mass (BC1000, Tanita corporation, Tokyo, Japan); body fat (DXA scan: Lunar DPX Madison, GE Healthcare, Wisconsin, USA); and lean mass (DXA scan: Lunar DPX Madison, GE Healthcare, Wisconsin, USA)] were collected two days prior to the experiments.
Volunteers were euhydrated prior to the experiments. Hydration status was assessed using a handheld refractometer (ATAGO Ltd, Tokyo, Japan) and determined as either euhydrated (USG < 1.020) or dehydrated (USG ≥ 1.020) according to the current guidelines. Water consumption was restricted during the experimental protocol. The same clothing consisting of a light-blue t-shirt (100% cotton), a black exercise short pant (100% polyester), and a pair of medium-high socks (100% cotton) were used by volunteers throughout the experiments. A pair of sunglasses was mandatory to be worn throughout the experiments. Furthermore, experiments took place during the same hour of the day for each participant and an 8-hour fasting was ensured prior to the experiments. Furthermore, participants were requested to avoid caffeine and alcohol consumption for at least twelve hours before the experiments, as well as to avoid salt and sugar consumption eight hours before the experiments.
During the study, continuous heart rate, core temperature, mean skin temperature, skin blood flow, and sweat rate were measured. Specifically, heart rate was collected using wireless heart rate monitors (Polar Team2. Polar Electro Oy, Kempele, Finland). Core temperature was collected using telemetric capsules (BodyCap, Caen, France). Skin temperature from four sites was measured using wireless thermistors (iButtons type DS1921H, Maxim/Dallas Semiconductor Corp., USA) and was expressed as mean skin temperature according to Ramanathan [mean skin temperature = 0.3(chest + arm) + 0.2(thigh + leg). Skin blood flow was measured with a laser Doppler flowmeter (PeriFlux 4000, Perimed, Stockholm, Sweden) at right forearm (brachioradialis) and leg (gastrocnemius). The probe (PROBE 413 Integrating Probe, Perimed, Stockhold, Sweden) was held in place with a plastic holder (PH 13, Perimed, Stockhold, Sweden). Sweat rate was measured at three regions [forehead, thigh (quadricep), and arm (bicep)] using ventilated capsule method. Thermal comfort (1 = comfortable; 5 = extremely uncomfortable), thermal sensation (-3 = cold; +3 = hot), and perceived exertion (6 = no exertion at all; 20 = maximal exertion), alongside cognitive performance (vigilance, divided attention, memory test, and reaction time) were assessed at baseline, pre work condition (01:40:00), and post work (03:00:00) conditions. Volunteers entered the chamber five minutes prior to the experiments to install data loggers and accompanied sensors on their body.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hot environment with radiation | Experimental | Other: Radiation and warm environmentExposure to hot environment (30°C WBGT) with radiation (800 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes) |
| Hot environment without radiation | Experimental | Other: Warm environmentExposure to hot environment (30°C WBGT) with radiation (0 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes) |
| Neutral environment with radiation | Experimental | Radiation: Neutral environment with radiationExposure to neutral environment (20°C WBGT) with radiation (800 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes) |
| Neutral environment without radiation | Active comparator | Other: Neutral environment without radiationExposure to neutral environment (20°C WBGT) with radiation (0 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy non-smoker individuals who exercise at least three times per week
Key exclusion criteria (1 listed)
- Non healthy individuals and smokers
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 |
|---|---|---|
| Radiation and warm environmentExposure to hot environment (30°C WBGT) with radiation (800 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes) | Other | Hot environment with radiation |
| Warm environmentExposure to hot environment (30°C WBGT) with radiation (0 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes) | Other | Hot environment without radiation |
| Neutral environment with radiationExposure to neutral environment (20°C WBGT) with radiation (800 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes) | Radiation | Neutral environment with radiation |
| Neutral environment without radiationExposure to neutral environment (20°C WBGT) with radiation (0 W/m2) Exposure for 03:20:00: * rest (two hours) * work (cycling) at 100 W (one hour) * recovery (twenty minutes) | Other | Neutral environment without radiation |
Primary outcome
Heart rate
Time frame: 03 hours and 20 minutes
Heart rate data were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
Mean skin temperature
Time frame: 03 hours and 20 minutes
Temperature at the skin surface area was continuously monitored using iButton sensors (type DS1921 H, Maxim/Dallas Semiconductor Corp., USA)
Core body temperature
Time frame: 03 hours and 20 minutes
Core body temperature was assessed throughout the entire protocol using telemetric capsules (e-Celsius, BodyCap, Caen, France) that was given to the workers to ingest prior to their work shift
Skin blood flow
Time frame: 03 hours and 20 minutes
Skin blood flow was measured throughout the entire protocol with a laser Doppler flowmeter (PeriFlux 4000, Perimed, Stockholm, Sweden) at right forearm (brachioradialis) and leg (gastrocnemius)
Sweat rate
Time frame: 03 hours and 20 minutes
Sweat rate was measured throughout the entire protocol at three regions [forehead, thigh (quadricep), and arm (bicep)] using ventilated capsule method
Perceived exertion
Time frame: Participants were assessed at baseline and every half an hour up until the end of the protocol at "hour 3".
We used the Borg 20th Scale (6 = no exertion at all; 20 = maximal exertion)
Cognitive performance (Vigilance)
Time frame: Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".
Vigilance was assessed via vigilance test. In this task two squares arranged vertically. A pattern jumps from one square to the other. Sometimes the pattern remains in one square. In this case volunteers had to touch the screen of a tablet computer as fast as possible. The total duration for the current task was set to 6 minutes. This is a well-known vigilance test described in the Test for Attentional Performance and previously used in the literature.
Thermal comfort
Time frame: Participants were assessed at baseline and every half an hour up until the end of the protocol at "hour 3".
Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable).
Thermal sensation
Time frame: Participants were assessed at baseline and every half an hour up until the end of the protocol at "hour 3".
Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)
Cognitive performance (Divided Attention)
Time frame: Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".
Divided attention task incorporates both auditory and visual stimuli in parallel. During the test a number of visual stimuli (crosses) appear in a random configuration in a 4X4 matrix. At the same time volunteers hear high and low beeps in a random order. The task is to detect whether crosses form a square and at the same time two high or low beeps are emitted twice in a row. This is a well-known vigilance test described in the Test for Attentional Performance and previously used in the literature.
Cognitive performance (Memory Test)
Time frame: Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".
This is a computerized version of Sternberg's memory task. In this task volunteers had to observe carefully a random sequence of one to six digits (0 to 9) painted in white and displayed for 1.2 seconds each. Thereafter, a two second delay was followed by a random test digit filled in yellow color. Participants had to response as fast as possible by pressing "yes" or "no" button to indicate where the yellow digit appeared in the previous sequence or not, respectively. In this test participants were tested in 24 trials.
Cognitive performance (Reaction Time)
Time frame: Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".
In this task participants had to respond as quickly as possible, by untouching the screen, after receiving a visual or acoustic stimulus.
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 29 Nov 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.
Andreas Flouris principal investigator
andreasflouris@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation and warm environment, Warm environment and Neutral environment with radiation in people with Heat Stress and Heat Strain, run by Petros Dinas at 1 site in Greece.
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 1 inclusion and 1 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 29 Nov 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 Greece. 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?
Heart rate (time frame: 03 hours and 20 minutes). The study lists 12 primary outcomes in all. 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 29 Nov 2023.