An interventional study of Heat intervention and Heat and air pollution mitigation intervention in Hypertension Arterial and 65 Years Older, sponsored by University of Cyprus. Recruiting at 2 sites in 2 countries. Open to participants aged 65 Years and older. 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 older adults with hypertension.
The main questions it aims to answer are:
Participants will:
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 102 is close to the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Cyprus is the lead sponsor of 28 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Subjects in this arm will receive no alerts for high temperatures nor recommendations for mitigation of heat-related health effects.
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.
Behavioral: 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.
Behavioral: 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.
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
Percentage dipping in night-time systolic blood pressure (SBP)
Primary health outcome will be the percentage dipping (Dipping %=(\[Mean Daytime SBP-Mean Night-time BP\]/Mean Daytime SBP)×100) in night-time SBP, that will be assessed at baseline, middle (after 1 month), and at end of the observation period (after 2 months). BP (systolic and diastolic blood pressure) will be recorded using non-invasive continuous cuff-less monitoring with advanced actigraphy for 24 hours at baseline, middle (after 1 month), and end of observation period (after 2 months). For the primary analysis, the impact of each intervention will be compared versus the control group and secondarily, the combined effect of the two intervention groups versus the control group will be assessed.
Time frame: Percentage dipping (Dipping %=([Mean Daytime SBP-Mean Night-time BP]/Mean Daytime SBP)×100) in night-time SBP will be assessed at baseline, middle (after 1 month), and at end of the 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.
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 measurements - for the whole duration of follow-up (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)
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 (WGBT) 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 PM2.5 and PM10 at residence
Particulate matter (PM2.5 and PM10) concentration levels (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)
Number of daily steps
Physical activity will be measured as number of daily steps, throughout the day by a wearable device (wristband).
Time frame: Daily measurements - for the whole duration of follow-up (2 months)
Serum C-reactive Protein (CRP) levels
Serum levels of CRP (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 CRP 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).
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
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University of Cyprus