An interventional study of Heat intervention and Heat and air pollution mitigation intervention in Sleep Quality, sponsored by University of Cyprus. Recruiting at 3 sites in 2 countries. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by University of Cyprus · Not applicable, Interventional, and Prevention
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:
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:
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 102 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University of Cyprus is the lead sponsor of 28 studies on the registry; 10 are open to participants now.
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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.
Exclusion Criteria:
Subjects in this arm will receive no alerts forhigh temperatures nor recommendations formitigation of heat-related health effects.
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
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 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
Also known as: Behavioral intervention to reduce exposure to heat
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.
Also known as: Behavioral intervention to reduce exposure to heat and air-pollution
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.
Time frame: The PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Sleep-wake pattern
Sleep-wake pattern will be estimated based on measurements of movement and heart rate obtained from a wearable device (wristband).
Time frame: 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.
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
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).
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
Heart rate measurements taken throughout the day by a wearable device (wristband).
Time frame: 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.
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
Heart rate will be measured using ECG.
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
Heart rate variability will be measured using ECG.
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).
Time frame: 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.
Time frame: Daily measurements - for the whole duration of follow-up (2 months).
Humidity
Humidity will be measured using iButton.
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
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).
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
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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
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).
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)
Plan to share: No
Started May 2026 (actual). Primary completion is estimated for Jul 2027, 14 months after the start.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 14 months is close to that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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University of Cyprus