Mitigation of Health Effects in Pregnant Women by Reducing Exposure to Heat and Air Pollution (ISMED CLIM PW)

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:

• 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 Overview

• Status: Recruiting
• Conditions: Sleep Quality
• Intervention / Treatment: Other: Heat intervention; Other: Heat and air pollution mitigation intervention

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Panayiotis Yiallouros, Professor; Phone Number: +35722895212; Email: yiallouros.panayiotis@ucy.ac.cy
• Study Contact Backup: Name: Panayiotis Kouis, PhD; Phone Number: +35722895243; Email: kouis.panayiotis@ucy.ac.cy

Study Locations

• Cyprus
  • Limassol, Cyprus
    • Recruiting
    • Medical School, University of Cyprus
    • Contact: Panayiotis Kouis; Phone Number: +35722895243; Email: kouis.panayiotis@ucy.ac.cy
• Italy
  • Catania, Italy
    • Recruiting
    • Azienda Ospedaliera Di Rilievo Nazionale Garibaldi Catania
    • Contact: Antonella Agodi; Phone Number: +390953782183; Email: antonella.agodi@unict.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• Drugs abuse
• Alcohol abuse
• Psychiatric disorders
• Severe mental disability that interferes with answering questions or following instructions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heat and air pollution intervention - Group Alerts, Recommendations and Air Cleaners; 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.	Other: Heat and air pollution mitigation intervention; 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.; Other Names: Behavioral intervention to reduce exposure to heat and air-pollution
No Intervention: Control group; Subjects in this arm will receive no alerts forhigh temperatures nor recommendations formitigation of heat-related health effects.
Experimental: Heat intervention - Personal Alerts and Specific Recommendations; 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.	Other: Heat intervention; 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; Other Names: Behavioral intervention to reduce exposure to heat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep-wake pattern	Sleep-wake pattern will be estimated based on measurements of movement and heart rate obtained from a wearable device (wristband).	Daily measurements - for the whole duration of follow-up (2 months)
Heart Rate	Heart rate will be measured using ECG.	Heart Rate 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).	Daily measurements - for the whole duration of follow-up (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).	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).	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).	Serum levels of sodium 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).	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).	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).	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).	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).	Urine osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 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.	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).	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).	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.	Systolic/Diastolic blood pressure 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.	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).	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 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).	Serum levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Wet-bulb globe temperature (WGBT)	Wet-bulb globe temperature, will be assessed as a thermal stress indicator.	Daily measurements - for the whole duration of follow-up (2 months).
Humidity	Humidity will be measured using iButton.	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).	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).	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).	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).	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).	Daily measurements - for the whole duration of follow-up (2 months)

Collaborators and Investigators

• Sponsor: University of Cyprus
• Collaborators: University of Catania; Azienda ospedaliera Garibaldi Catania
• Investigators: Principal Investigator: Panayiotis Yiallouros, Professor, University of Cyprus

Publications and helpful links

General Publications

• Buysse 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; intervention; Sleep quality; personal ambient temperature exposure
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Public Health; Environment and Public Health; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Thermodynamics; Weather; Atmosphere; Meteorological Concepts; Temperature; Environmental Pollution; Hot Temperature; Air Pollution
• Other Study ID Numbers: 101156653.LL2.PW; 101156653 (Other Identifier: European Commission)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No