Sleep QualityISMED CLIM PWNCT07609433
Mitigation of Health Effects in Pregnant Women by Reducing Exposure to Heat and Air Pollution
A study testing Heat intervention and Heat and air pollution mitigation intervention in people with Sleep Quality, run by University of Cyprus at 3 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 pregnant women. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality
- 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
- 3 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant Women (PW) aged 20 to 35 years
- being in the 2nd trimester of a singleton pregnancy (15th-27th week of gestation)
- Living in Catania (Italy) or Limassol (Cyprus) districts
- Clinically healthy
- No Gestational diabetes
- No pre-eclampsia
- No severe pregnancy complications
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
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Italy2 sites, 2 recruiting
- Recruiting
Azienda Ospedaliera Di Rilievo Nazionale Garibaldi Catania
Catania
Giuseppe Ettore, Dr, +390957595944, giuseppe.ettore@gmail.com
Antonella Agodi, Professor, antonella.agodi@unict.it
- Recruiting
Azienda Ospedaliera Di Rilievo Nazionale Garibaldi Catania
Catania
Antonella Agodi, +390953782183, antonella.agodi@unict.it
Cyprus1 site, 1 recruiting
- Recruiting
Medical School, University of Cyprus
Limassol
Panayiotis Kouis, +35722895243, kouis.panayiotis@ucy.ac.cy
About this study
Official title: Innovative Solutions Across the MEDiterranean for Mitigation of Climate Change-related heaLth rIsks and Enhancing Health systeM Resilience in Pregnant Women
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 pregnant women.
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 sleep difficulties experienced by pregnant women, measured using the Pittsburgh Sleep Quality Index?
Researchers will compare measurements between pregnant women carrying out their daily activities in the absence of intervention (control group), those carrying out their daily activities with behavioural recommendations (recommendation intervention group) and those carrying out their daily 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 sleep 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 Pittsburgh Sleep Quality Index questionnaire in three repeated assessments
- Provide samples of urine and blood biomarkers in three repeated assessments.
- Conditions
- Sleep Quality
- Being tested
- Heat intervention, Heat and air pollution mitigation intervention
- Keywords
- Pregnancy, intervention, Sleep quality, personal ambient temperature exposure
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
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 forhigh temperatures nor recommendations formitigation of heat-related health effects. |
| Heat intervention - Personal Alerts and Specific Recommendations | Experimental | Subjects in this group will receive timelypersonal 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.
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).
Secondary outcomes (27)
Sleep-wake pattern
Sleep-wake pattern 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 self-reported evaluation
The sleep-wake 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 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).
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).
Daily heart rate
Heart rate measurements taken throughout the day by a wearable device (wristband).
Measured: Daily measu.ments - for the whole duration of follow-up (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).
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).
Humidity
Humidity will be measured using iButton.
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 2.5 (PM 2.5) at work
Indoor concentration levels of PM2.5 (micrograms per cubic meter of air) at participants' work place 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).
Indoor concentration levels of Particulate Matter 10 (PM 10) at work
Indoor concentration levels of PM10 (micrograms per cubic meter of air) at participants' work place 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)
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep QualityStudies 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
- Azienda ospedaliera Garibaldi Catania, University of Catania
- 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
- NCT07609433
- Sponsor's protocol ID
- 101156653.LL2.PW
- Other IDs
- 101156653
- Acronym
- ISMED CLIM PW
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
PubMed 13638508Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771
Study at a glance
From the registry record, last updated by the sponsor on 5 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 and Enhancing Health systeM Resilience in Pregnant Women
- ClinicalTrials.gov ID
- NCT07609433
- Acronym / sponsor ID
- ISMED CLIM PW / 101156653.LL2.PW
- Conditions
- Sleep Quality
- Keywords
- Pregnancy, intervention, Sleep quality, personal ambient temperature exposure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of CyprusUniversity, hospital or other
- Collaborators
- Azienda ospedaliera Garibaldi Catania, University of Catania
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 27 May 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 pregnant women.
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 sleep difficulties experienced by pregnant women, measured using the Pittsburgh Sleep Quality Index?
Researchers will compare measurements between pregnant women carrying out their daily activities in the absence of intervention (control group), those carrying out their daily activities with behavioural recommendations (recommendation intervention group) and those carrying out their daily 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 sleep 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 Pittsburgh Sleep Quality Index questionnaire in three repeated assessments
- Provide samples of urine and blood 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 forhigh temperatures nor recommendations formitigation of heat-related health effects. |
| Heat intervention - Personal Alerts and Specific Recommendations | Experimental | Other: Heat interventionSubjects in this group will receive timelypersonal 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
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant Women (PW) aged 20 to 35 years
- being in the 2nd trimester of a singleton pregnancy (15th-27th week of gestation)
- Living in Catania (Italy) or Limassol (Cyprus) districts
- Clinically healthy
- No Gestational diabetes
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
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).
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.
27 secondary outcomes
Sleep-wake pattern
Time frame: Daily measurements - for the whole duration of follow-up (2 months)
Sleep-Wake 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).
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).
Daily heart rate
Time frame: Daily measu.ments - for the whole duration of follow-up (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).
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).
Humidity
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 2.5 (PM 2.5) at work
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).
Indoor concentration levels of Particulate Matter 10 (PM 10) at work
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)
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)
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 5 Jun 2026.
- Background: PubMed 13638508HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- 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
3 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 Sleep Quality, run by University of Cyprus at 3 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 5 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 3 sites in Italy, Cyprus. 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?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07609433, which also lists 2 linked publications.
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 5 Jun 2026.