Heat StrainISMED-CLIM OWNCT07634952
Mitigation of Health Effects in Outdoor Workers by Reducing Exposure to Heat and Air Pollution
A study testing Heat intervention and Heat and air pollution mitigation intervention in people with Heat Strain, run by University of Cyprus at 2 sites in 2 countries.
Trial summary
The goal of this clinical trial is to assess the effectiveness of an intervention (combination of behavioural recommendations and technical measures) in reducing personal exposure to heat and air pollution and related health effects in outdoor workers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat Strain
- What is being tested?
- Heat intervention and Heat and air pollution mitigation intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years old
- Municipality outdoor workers
- Regularly working outdoors for al least 6 hours per day
- Living in León (Spain) or Trikala (Greece)
- Clinically healthy
- No history of diabetes mellitus type 2 (DM2)
- No history of arterial hypertension
Who cannot join
- Currently smoking
- Presence of any smoking residents in the household
- Not residing at the household for at least 5 days a week
- Planning to move from the current home within the next two months
- No access to Wi-Fi or 4G/5G mobile phone
- Severe chronic conditions (congestive heart failure, ischemic heart disease, significant valvular heart disease, DM2, inflammatory diseases, renal failure, or active cancer)
Show all 10Show fewer
- Drugs abuse
- Alcohol abuse
- Psychiatric disorders
- Severe mental disability that interferes with answering questions or following instructions
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Greece1 site, 1 recruiting
- Recruiting
University of Thessaly
Trikala
Andreas Flouris, Professor, +30 24310 47072, aflouris@uth.gr
Spain1 site, 1 recruiting
- Recruiting
University of Léon
León
Belén Carballo-Leyenda, Professor, +34 987 293 023, abcarl@unileon.es
About this study
Official title: Innovative Solutions Across the MEDiterranean for Mitigation of Climate Change-related heaLth rIsks in Outdoor Workers
The goal of this clinical trial is to assess the effectiveness of an intervention (combination of behavioural recommendations and technical measures) in reducing personal exposure to heat and air pollution and related health effects in outdoor workers.
The main questions it aims to answer are:
Read more
- Does the intervention (combination of behavioral recommendations for heat mitigation) reduce personal ambient temperature exposure, measured using a wearable device (iButton)?
- Does the intervention (combination of behavioral recommendations for air pollution mitigation and use of indoor air cleaners) reduce indoor exposure to air pollution, measured using indoor air quality sensors (Purple Air)?
- Does the intervention (combination of behavioral recommendations for heat mitigation) reduce physiological strain experienced by individuals working in hot environments, measured using the Heat Strain Score Index?
Researchers will compare measurements between outdoor workers carrying out their activities in the absence of intervention (control group), those carrying out their activities with behavioural recommendations (recommendation intervention group) and those carrying out their activities with both behavioural recommendations for heat mitigation and continuous use of indoor air cleaners in their house (heat and air pollution mitigation intervention group) to see if changes in temperature exposure and physiological strain are different between intervention groups.
Participants will:
- Wear the wearable devise for continuous personal ambient temperature monitoring (ibutton) daily for a period of three months
- Have their core temperature measured using an eCelsius medical capsule in three repeated assessments
- Complete the Heat Strain Score Index questionnaire in three repeated assessments
- Provide samples of urine, blood, saliva and hair for measurement of various biomarkers in three repeated assessments
- Conditions
- Heat Strain
- Being tested
- Heat intervention, Heat and air pollution mitigation intervention
- Keywords
- outdoor workers, heat strain, intervention, personal ambient temperature exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat interventionOther
Also called Behavioral intervention to reduce exposure to heat
The participants in this group of intervention will receive timely personal alerts for high temperatures and specific recommendations to reduce exposure to heat by changing patterns of time spent and physical activity performed outdoors, regulating indoor temperature using fans and/or air conditioning devices, as well as recommendations for mitigation of heat-related health effects (hydration, body cooling) in written and animated format, through mobile phones, web application and online tools to be developed by the project research team
Heat and air pollution mitigation interventionOther
Also called Behavioral intervention to reduce exposure to heat and air-pollution
The participants in this intervention group will receive alerts and recommendations as in group "Heat intervention" and, in addition, continuously use air cleaners with HEPA filters for removing PM from indoor air in their residences and workplaces.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Subjects in this arm will receive no alerts for high temperatures nor recommendations for mitigation of heat-related health effects. |
| Heat intervention - Personal Alerts and Specific Recommendations | Experimental | Subjects in this group will receive timely personal alerts for high temperatures and specific recommendations to reduce exposure to heat and mitigation of heat-related health effects in written and animated format through mobile phones, mobile applications and online tools. Receives: Other: Heat intervention |
| Heat and air pollution intervention - Group Alerts, Recommendations and Air Cleaners | Experimental | Subjects in this group will receive alerts and recommendations as in group "Heat intervention" and in addition, continuously use of air cleaners with HEPA filter for removing PM from indoor air in their residences and workplaces to provide evidence for health benefits. Receives: Other: Heat and air pollution mitigation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heat Strain Score Index
The Heat Strain Score Index (HSSI) is a questionnaire-based assessment tool used to assess the risk of heat strain on individuals exposed to hot environments, using a questionnaire. It integrates multiple factors, such as environmental conditions, work intensity, clothing, and physiological responses, to estimate the likelihood of heat stress affecting a person.
Measured: The HSSI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Secondary outcomes (26)
Daily heart rate
Heart rate measurements taken throughout the day by a wearable device (wristband).
Measured: Daily measurements - for the whole duration of follow-up (2 months) .
Sleep-wake time
Sleep-wake time (minutes) will be estimated based on measurements of movement and heart rate obtained from a wearable device (wristband)
Measured: Daily measurements - for the whole duration of follow-up (2 months)
Sleep-Wake Time self-reported evaluation
The sleep-wake time (minutes) self-reported evaluation will be carried out using a predefined sleep diary which will be completed by the participant on the morning after he/she wakes up. Each assessment of sleep-wake time self-reported evaluation will be carried out for a whole week.
Measured: The sleep-wake self-reported evaluation will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. The PSQI is commonly used in both clinical and research settings to evaluate various aspects of sleep. It is a valuable tool for assessing sleep quality as it captures multiple dimensions of sleep, including both subjective experiences and objective parameters. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Measured: The PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Hamilton Anxiety Rating Scale
The Hamilton Anxiety Rating Scale will be carried out to assess the severity of a person's anxiety. The Hamilton Anxiety Rating Scale ranges from 0 to 56, where higher scores indicate greater anxiety severity. The scoring is divided into severity tiers: <17 (mild), 18-24 (mild to moderate), and 25-56 (moderate to severe). The scale consists of 14 items, each rated from 0 to 4 points. It evaluates both psychic anxiety (e.g., tension, fears, mood) and somatic anxiety (physical complaints).
Measured: The Hamilton Anxiety Rating Scale will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Systolic/Diastolic Blood Pressure
Measurements of Systolic/Diastolic Blood Pressure will be recorded.
Measured: Systolic/Diastolic blood pressure will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Heart Rate
Heart rate will be measured using ECG.
Measured: Heart Rate will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Heart Rate Variability
Heart rate variability will be measured using ECG.
Measured: The heart rate variability will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum C-reactive Protein Levels
Serum levels of C-reactive protein (mg/L), as a marker of systemic inflammation, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Measured: Serum levels of C-reactive protein will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum Urea Levels
Serum levels of urea (mg/dL), as a marker of renal function, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Measured: Serum levels of urea will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum Creatinine Levels
Serum levels of creatinine (mg/dL), as a marker of renal function, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Measured: Serum levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum Sodium levels
Serum levels of sodium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Measured: Serum levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum Potassium Levels
Serum levels of potassium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Measured: Serum levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum Osmolality
Serum osmolality (mOsm/kg), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Measured: Serum osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine Creatinine Levels
Urine levels of creatinine (mg/dL), as a marker of renal function, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Measured: Urine levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine Sodium levels
Urine levels of sodium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Measured: Urine levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine Potassium levels
Urine levels of potassium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Measured: Urine levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine Osmolality
Urine osmolality (mOsm/kg), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Measured: Urine osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Hair cortisol levels
Hair cortisol levels (pg/mg), as a marker of stress, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Measured: Hair cortisol levels will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Saliva alpha-amylase levels
Saliva levels of alpha-amylase (U/mL), as a marker of stress, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Measured: Saliva levels of alpha-amylase will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Humidity
Humidity will be measured using iButton.
Measured: Daily measurements - for the whole duration of follow-up (2 months).
The personal ambient temperature profile of all participants
Personal exposures of participants will be monitored continuously during the two observation months with wearable sensors to be always worn and assess personal exposure to ambient (indoor and outdoor) temperature (iButton).
Measured: Daily measurements - for the whole duration of follow-up (2 months)
Wet-bulb globe temperature (WGBT)
Wet-bulb globe temperature, will be assessed as a thermal stress indicator.
Measured: Daily measurements - for the whole duration of follow-up (2 months).
Indoor concentration levels of Particulate Matter 2.5 (PM 2.5) at residence
Indoor concentration levels of PM2.5 (micrograms per cubic meter of air) at participants' residences will be measured continuously indoors using commercial lightweight sensors (Alpha sense).
Measured: Daily measurements - for the whole duration of follow-up (2 months).
Indoor concentration levels of Particulate Matter 10 (PM 10) at residence
Indoor concentration levels of PM10 (micrograms per cubic meter of air) at participants' residences will be measured continuously indoors using commercial lightweight sensors (Alpha sense).
Measured: Daily measurements - for the whole duration of follow-up (2 months).
Number of daily steps
Number of daily steps will be measured throughout the day by a wearable device (wristband).
Measured: Daily measurements - for the whole duration of follow-up (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 May 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StrainStudies 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
- Parallel groups
- Model description
- Participants will be randomized into three parallel study groups to a) receive no alerts for high temperatures nor recommendations for mitigation of health effects (business as usual scenario, control group), b) receive timely personal alerts for high temperatures and specific recommendations to reduce exposure to heat by changing patterns of time spent and physical activity performed outdoors, regulating indoor temperature using fans and or A/C devices, as well as recommendations for mitigation of health effects (hydration, body cooling) in written and animated format, through mobile phone and web application tools (heat mitigation intervention), and c) receive alerts and recommendations as in group (b) and in addition continuously use air cleaners with HEPA filter for removing PM from indoor air in their residences (heat and air pollution mitigation intervention)
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cyprus
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de León, University of Thessaly
- Responsible party
- Principal investigator, Panayiotis Yiallouros, University of Cyprus
- Investigators
- Panayiotis Yiallouros, Professor, Principal investigator, University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634952
- Sponsor's protocol ID
- 101156653.LL1.OW
- Other IDs
- 101156653
- Acronym
- ISMED-CLIM OW
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Solutions Across the MEDiterranean for Mitigation of Climate Change-related heaLth rIsks in Outdoor Workers
- ClinicalTrials.gov ID
- NCT07634952
- Acronym / sponsor ID
- ISMED-CLIM OW / 101156653.LL1.OW
- Conditions
- Heat Strain
- Keywords
- outdoor workers, heat strain, intervention, personal ambient temperature exposure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of CyprusUniversity, hospital or other
- Collaborators
- Universidad de León, University of Thessaly
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 9 Jun 2026 (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 goal of this clinical trial is to assess the effectiveness of an intervention (combination of behavioural recommendations and technical measures) in reducing personal exposure to heat and air pollution and related health effects in outdoor workers.
The main questions it aims to answer are:
- Does the intervention (combination of behavioral recommendations for heat mitigation) reduce personal ambient temperature exposure, measured using a wearable device (iButton)?
- Does the intervention (combination of behavioral recommendations for air pollution mitigation and use of indoor air cleaners) reduce indoor exposure to air pollution, measured using indoor air quality sensors (Purple Air)?
- Does the intervention (combination of behavioral recommendations for heat mitigation) reduce physiological strain experienced by individuals working in hot environments, measured using the Heat Strain Score Index?
Researchers will compare measurements between outdoor workers carrying out their activities in the absence of intervention (control group), those carrying out their activities with behavioural recommendations (recommendation intervention group) and those carrying out their activities with both behavioural recommendations for heat mitigation and continuous use of indoor air cleaners in their house (heat and air pollution mitigation intervention group) to see if changes in temperature exposure and physiological strain are different between intervention groups.
Participants will:
- Wear the wearable devise for continuous personal ambient temperature monitoring (ibutton) daily for a period of three months
- Have their core temperature measured using an eCelsius medical capsule in three repeated assessments
- Complete the Heat Strain Score Index questionnaire in three repeated assessments
- Provide samples of urine, blood, saliva and hair for measurement of various biomarkers in three repeated assessments
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized into three parallel study groups to a) receive no alerts for high temperatures nor recommendations for mitigation of health effects (business as usual scenario, control group), b) receive timely personal alerts for high temperatures and specific recommendations to reduce exposure to heat by changing patterns of time spent and physical activity performed outdoors, regulating indoor temperature using fans and or A/C devices, as well as recommendations for mitigation of health effects (hydration, body cooling) in written and animated format, through mobile phone and web application tools (heat mitigation intervention), and c) receive alerts and recommendations as in group (b) and in addition continuously use air cleaners with HEPA filter for removing PM from indoor air in their residences (heat and air pollution mitigation intervention)
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Subjects in this arm will receive no alerts for high temperatures nor recommendations for mitigation of heat-related health effects. |
| Heat intervention - Personal Alerts and Specific Recommendations | Experimental | Other: Heat interventionSubjects in this group will receive timely personal alerts for high temperatures and specific recommendations to reduce exposure to heat and mitigation of heat-related health effects in written and animated format through mobile phones, mobile applications and online tools. |
| Heat and air pollution intervention - Group Alerts, Recommendations and Air Cleaners | Experimental | Other: Heat and air pollution mitigation interventionSubjects in this group will receive alerts and recommendations as in group "Heat intervention" and in addition, continuously use of air cleaners with HEPA filter for removing PM from indoor air in their residences and workplaces to provide evidence for health benefits. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-65 years old
- Municipality outdoor workers
- Regularly working outdoors for al least 6 hours per day
- Living in León (Spain) or Trikala (Greece)
- Clinically healthy
Key exclusion criteria (10 listed)
- Currently smoking
- Presence of any smoking residents in the household
- Not residing at the household for at least 5 days a week
- Planning to move from the current home within the next two months
- No access to Wi-Fi or 4G/5G mobile phone
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 |
|---|---|---|
| Heat interventionAlso: Behavioral intervention to reduce exposure to heatThe participants in this group of intervention will receive timely personal alerts for high temperatures and specific recommendations to reduce exposure to heat by changing patterns of time spent and physical activity performed outdoors, regulating indoor temperature using fans and/or air conditioning devices, as well as recommendations for mitigation of heat-related health effects (hydration, body cooling) in written and animated format, through mobile phones, web application and online tools to be developed by the project research team | Other | Heat intervention - Personal Alerts and Specific Recommendations |
| Heat and air pollution mitigation interventionAlso: Behavioral intervention to reduce exposure to heat and air-pollutionThe participants in this intervention group will receive alerts and recommendations as in group "Heat intervention" and, in addition, continuously use air cleaners with HEPA filters for removing PM from indoor air in their residences and workplaces. | Other | Heat and air pollution intervention - Group Alerts, Recommendations and Air Cleaners |
Primary outcome
Heat Strain Score Index
Time frame: The HSSI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
The Heat Strain Score Index (HSSI) is a questionnaire-based assessment tool used to assess the risk of heat strain on individuals exposed to hot environments, using a questionnaire. It integrates multiple factors, such as environmental conditions, work intensity, clothing, and physiological responses, to estimate the likelihood of heat stress affecting a person.
26 secondary outcomes
Daily heart rate
Time frame: Daily measurements - for the whole duration of follow-up (2 months) .
Sleep-wake time
Time frame: Daily measurements - for the whole duration of follow-up (2 months)
Sleep-Wake Time self-reported evaluation
Time frame: The sleep-wake self-reported evaluation will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Pittsburgh Sleep Quality Index (PSQI)
Time frame: The PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Hamilton Anxiety Rating Scale
Time frame: The Hamilton Anxiety Rating Scale will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Systolic/Diastolic Blood Pressure
Time frame: Systolic/Diastolic blood pressure will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Heart Rate
Time frame: Heart Rate will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Heart Rate Variability
Time frame: The heart rate variability will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum C-reactive Protein Levels
Time frame: Serum levels of C-reactive protein will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum Urea Levels
Time frame: Serum levels of urea will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum Creatinine Levels
Time frame: Serum levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum Sodium levels
Time frame: Serum levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum Potassium Levels
Time frame: Serum levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum Osmolality
Time frame: Serum osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine Creatinine Levels
Time frame: Urine levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine Sodium levels
Time frame: Urine levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine Potassium levels
Time frame: Urine levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine Osmolality
Time frame: Urine osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Hair cortisol levels
Time frame: Hair cortisol levels will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Saliva alpha-amylase levels
Time frame: Saliva levels of alpha-amylase will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Humidity
Time frame: Daily measurements - for the whole duration of follow-up (2 months).
The personal ambient temperature profile of all participants
Time frame: Daily measurements - for the whole duration of follow-up (2 months)
Wet-bulb globe temperature (WGBT)
Time frame: Daily measurements - for the whole duration of follow-up (2 months).
Indoor concentration levels of Particulate Matter 2.5 (PM 2.5) at residence
Time frame: Daily measurements - for the whole duration of follow-up (2 months).
Indoor concentration levels of Particulate Matter 10 (PM 10) at residence
Time frame: Daily measurements - for the whole duration of follow-up (2 months).
Number of daily steps
Time frame: Daily measurements - for the whole duration of follow-up (2 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- 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.
Panayiotis Yiallouros, Professor principal investigator
University of Cyprus
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat intervention and Heat and air pollution mitigation intervention in people with Heat Strain, run by University of Cyprus at 2 sites in 2 countries.
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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece, Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Panayiotis Yiallouros, Professor (+35722895212, yiallouros.panayiotis@ucy.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heat Strain Score Index (time frame: The HSSI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).). 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 16 Jun 2026.