ClinicalTrials.gg
RecruitingNCT07510061ICARUSUpdated Apr 3, 2026

Title: ICARUS - Psycho-physiological Profiling of Low and High Heat-resilient Individuals

An interventional study of Controlled Heat and Ultraviolet Radiation Exposure Protocol in Skin Cancer, Heat Tolerance and Heat-related Illness, sponsored by University of Thessaly. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by University of Thessaly · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2025, registered Feb 2026).
  • Started Nov 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The escalating environmental heat-stress associated with global warming is a societal challenge with large and potential harmful consequences for humans. Excess morbidity and mortality during heat waves provides strong evidence for fatal outcomes. However, it is unclear why some people are particularly vulnerable and get sick from hyperthermia, while others adapt and tolerate exposure.

The Icarus project aims to provide a psycho-physiological framework for improved mitigation of the health threats associated with global warming. Combining expertise in integrative thermal physiology, pharmacology, photobiology, psychology and machine learning, we will collaborate on comprehensive cross-scientific studies using controlled lab-exposure combined with investigations in ecological settings including vulnerable and highly tolerant people across populations from northern to southern Europe.

Advanced algorithms will be developed to generate personalized alerts and advising based on behavioral patterns, psychological profiling, predicted vulnerability and willingness to adopt resilience-building strategies.

Global warming is projected to continue towards the end of the 21st century and constitutes an increasing threat to human health unless we as individuals and collectively become better in preventing acute effects, as well as devise sustainable strategies to limit further anthropogenic warming of the climate system. Acutely, improved guidance is important for both individual and public health, where Icarus aims at providing a highly improved basis for preventing heat-related disease, advising or nudging people towards pro-health behavior, including smarter use of technologies to mitigate heat stress, or adjusting medication to reduce adverse effects during heat events. In support of the sustainability agenda, our framework also forms a novel basis for developing advising algorithms relevant for optimization of climate change mitigation policy-making.

Read the detailed description

Warming of the climate system is ongoing and there is strong evidence for detrimental effects of environmental heat stress on human with impact on public health and quality of life for billions of people globally - with the most damaging effects on societies in the hottest parts of the world. However, recent heatwaves in Canada, USA, and Northern Europe saw temperatures surpassing 40°C. Documented impacts on mortality show how climate change and the associated geographical spread of heatwaves also have health consequences in regions previously spared from high temperatures. At the same time, cutaneous melanoma already is a documented and increasing public health concern and characterized by high incidence in fair-skinned populations of European descent, particularly in Central and North European countries. The incidence of 29.7 per 100,000 person-years in Denmark is the 3rd highest globally, compared to the world average of 3.4. Alarmingly, the World Health Organization (WHO) projects that the number of new cases of melanoma per year will increase by more than 50% from 2020 to 2040.

It is abundantly clear that certain populations are more vulnerable to global warming and that certain individuals within each population are more susceptible to heat-stress than others. In the Icarus project, we will find ways to identify these people and at a large scale protect using predictive algorithms. Achieving this ambition may save lives, reduce the burden on healthcare systems, support the global sustainability agenda including UN defined sustainability goals such as the prevention of poverty via improved productivity. Thus, public health, sustainability and economic benefits from this ambitious project are clear should it succeed.

The fatal outcome of exposure to extreme heat and sunlight, as described in the myth about Icarus and scientifically documented with epidemiological evidence for excess death rates during heatwaves is, however, only the tip of the iceberg in terms of public health problems and societal impact imposed by global warming. We have documented the occupational health burden, productivity losses and economic costs associated with elevated environmental heat and we have shed light on the interaction between heat stress and exposure to solar radiation. The later with major isolated health effects of ultraviolet radiation (UVR) on the skin. Our pilot observations from combined heat-radiation exposure studies indicate that some individuals, both before and after acclimatization, are very tolerant and show almost no detrimental effects on motor-cognitive performance; while others (healthy; matched for fitness and age) show drastic changes in clinical outcomes and major declines in physical and mental performance. It is well known that sunlight exposure, and in particular certain UVR wavelengths, has direct damaging effects on the skin, but there is a large knowledge gap on its interaction with thermal physiological effects. Also, there is no research on acclimatization effects and very limited understanding of the interaction between impacts on cognitive function and psychological/behavioral factors. This is central for understanding heat vulnerability at the individual level and how it subsequently affects public health - as those at highest risk become ill, hospitalized, or add to the mortality statistics. Furthermore, these interactions are fundamental for the development of a psychophysical framework and improve the ability to understand and subsequently influence collective behavior, which is highly relevant for the implementation of policies and climate change mitigation strategies.

Differences in heat vulnerability are also observed at the population-level with markedly lower temperature thresholds for excess mortality in North compared to South European countries, but it is largely unknown if this pronounced difference in heat resilience relates to a superior "physiological defense system" in South Europeans orprimarily relates to different social experiences of heat and thus different behaviors i.e., more appropriate thermoregulatory behavior in South Europeans. Higher risk taking (e.g., inappropriate "sun-bathing culture") is also a highly relevant factor in terms of skin damage (DNA mutation and photocarcinogenesis) and the associated risk for developing skin cancer. For instance, in a recent pilot study, we observed a 10-fold higher excretion of cyclobutane thymine dimers in the urine (as a marker of skin DNA damage) of Danish volunteers after a winter vacation to a sunny region, compared to their peers who freely chose to be less exposed.

Analogous to the mythical Icarus, who flew too close to the sun, our recent pilot data individual data from papers by our consortium show that vulnerable people, collectively translating into differences at the population level, arenot able to sense and comprehend the danger associated with exposure to solar radiation. If we - unlike Icarus' father - are to become better at protecting individuals atrisk and advise humanity at large, we need an improved and interdisciplinary approach to mitigate and understand the risks imposed by escalating environmental heat exposure.

The Icarus project will generate a psycho-physical framework for improved ability tomitigate the threats associated with increased exposure aggravated by global warming: from individual vulnerability to heat and sun exposure, to public health and collective behavior. The developed framework shall allow us to identify patterns and develop algorithms for early detection of those susceptible to becoming sick from heat and sun exposure. This may directly benefit public health as well as bridge the gap from individual to collective behavior which has relevance for policy-making and climate change mitigation. To achieve the ambitious overall aim, we have composed a consortium led by experts in thermal physiology, psychology, dermatology, pharmacological prevention of adverse effects from sunlight exposure, as well as artificial intelligence and machine learning - allowing us to complete the inter-disciplinary studies and sub-tasks.

02

Conditions studied

  • Skin Cancer
  • Heat Tolerance
  • Heat-related Illness
  • Hyperthermia
  • Heat Stress
  • Ultraviolet Radiation-Related Skin Damage

Keywords

  • Heat Stress
  • Heat-Related Illness
  • Heat Vulnerability
  • Heat Intolerance
  • Hyperthermia
  • Environmental Heat Exposure
  • Thermal Stress
  • Ultraviolet Radiation Exposure
  • Skin DNA Damage
  • Cardiovascular Strain (Heat-Induced)
  • Cognitive Impairment (Heat-Induced)
  • Occupational Heat Stress
  • Climate Change and Health
  • Heat Resilience
  • Heat Acclimatization
03

In context

Skin Neoplasms

604 studies on the registry are indexed under Skin Neoplasms; 126 are open to participants now.

This study's planned enrollment of 80 is above the median of 55 across 408 interventional studies indexed under Skin Neoplasms.

Browse Skin Neoplasms studies →

Lead sponsor

University of Thessaly is the lead sponsor of 195 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Study Population

Healthy adult volunteers residing in Denmark (Northern Europe) or Greece (Southern Europe).

Inclusion criteria

Inclusion Criteria

  • Age 18-65 years (or your protocol-specific age range)
  • Healthy as determined by medical history screening questionnaire
  • Able to provide written
  • Able to complete heat exposure and light exercise protocol
  • No heat acclimatization or extensive sun exposure in the previous 4 weeks
  • Fitzpatrick skin type I-IV (if applicable for UV testing)
  • Willing to undergo blood sampling, urine collection, and skin

Exclusion criteria

Exclusion Criteria

  • History of cardiovascular, metabolic, neurological, or dermatological disease
  • History of heat-related illness (e.g., heat stroke)
  • Use of medications affecting thermoregulation or cardiovascular function
  • Smoking or substance abuse
  • Pregnancy or breastfeeding
  • Abnormal or uncontrolled hypertension
  • Recent severe sunburn or UV treatment
  • to skin
  • Inability to tolerate heat exposure during screening
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Standardized Heat and UV Exposure Protocol

    Participants undergo a standardized 4-hour laboratory protocol to assess physiological and psychological responses to controlled heat and ultraviolet radiation exposure. The protocol includes passive heat exposure (40°C, 30% relative humidity), simulated solar UV radiation (up to 3 Standard Erythema Doses), light exercise-induced heat stress, and recovery. Core and skin temperature, cardiovascular and thermoregulatory responses, orthostatic tolerance, echocardiography, blood and urine biomarkers, skin biopsies, motor-cognitive performance, and psychological measures are assessed repeatedly. Subgroup analyses compare participants by geographic location (Denmark vs Greece) and pre-defined heat tolerance status (low vs high).

    Other: Controlled Heat and Ultraviolet Radiation Exposure Protocol

Interventions

  • OtherControlled Heat and Ultraviolet Radiation Exposure Protocol

    Participants undergo a standardized 4-hour laboratory-based environmental exposure protocol consisting of passive heat exposure (40°C, 30% relative humidity), simulated solar ultraviolet radiation (up to 3 Standard Erythema Doses), light exercise-induced heat stress using a cycle ergometer, and recovery. Physiological, cardiovascular, thermoregulatory, biochemical, and psychological responses are assessed repeatedly throughout the protocol. The intervention is designed to quantify individual heat tolerance and combined heat-UV physiological strain under controlled conditions.

    Also known as: Standardized Heat Stress Protocol, Simulated Solar Radiation Exposure

06

What researchers measure

Primary outcomes

  1. Physiological Heat Tolerance

    Maximum tolerable exposure time during the standardized heat and ultraviolet radiation protocol. (units of measure: Minutes)

    Time frame: During 4-hour laboratory protocol

  2. Heart Rate Response

    Heart rate measured continuously during heat and UV exposure to assess cardiovascular strain \[unit: beats per minute (bpm)\]

    Time frame: During 4-hour laboratory protocol

Secondary outcomes

  1. Blood Pressure Response

    Stroke volume assessed to evaluate cardiac function during environmental stress (unit: mL/beat)

    Time frame: During 4-hour laboratory protocol

  2. Cardiac Output

    Ability to maintain blood pressure and consciousness during postural change following exposure (unit : L/min)

    Time frame: During 4-hour laboratory protocol

  3. Orthostatic Tolerance

    Ability to maintain blood pressure and consciousness during postural change following exposure \[unit: time to presyncope (minutes)\]

    Time frame: Every 60 min during the protocol

  4. Echocardiographic Parameters

    Cardiac structure and function assessed via echocardiography (ejection fraction) (unit:%)

    Time frame: Every 60 min during the protocol

07

Study locations

2 of 2 sites recruiting
  • Københavns Universitet
    Copenhagen, 2100, Denmark
    Recruiting
  • Department of Physical Education and Sport Science
    Trikala, Thessaly 42100, Greece
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Apr 2027, 17 months after the start.

Of 94 non-industry interventional studies with no phase under Skin Neoplasms, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's planned 17 months is below that.

Counting every sponsor, half of 116 studies reached it within 27 months; a quarter within 10 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2026
First posted
Apr 3, 2026
StartActual
Nov 1, 2025
Primary completionEst.
Apr 30, 2027
CompletionEst.
Apr 30, 2027
Last update
Apr 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07510061
Responsible party
Georgia Ntina (Head of Finance & Administration at FAME lab, DPESS, UTH, University of Thessaly) — Principal investigator
First posted
Apr 3, 2026
Start date
Nov 1, 2025
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Apr 3, 2026

Study contacts

Maria Vliora, PhD
Contact
mvliora@gmail.com
6979642540 ext. +30
Konstantinos Mantzios, PhD
Contact
konstantinosmantzios@gmail.com
6948626874 ext. +30
Andreas D Flouris, PhD
principal investigator · 1FAME Laboratory, Department of Exercise Science, University of Thessaly, Trikala, Greece
Lars Nybo, PhD
principal investigator · Department of Nutrition, Exercise and Sports, August Krogh Building, University of Copenhagen, Copenhagen, Denmark.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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