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NCT Number: NCT07606859

Mitigation of Health Effects in Older Adults With Hypertension by Reducing Exposure to Heat and Air Pollution

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:

* 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) improve the abnormalities in circadian blood pressure variation experienced by older adults with hypertension, assessed using advanced actigraphy? Researchers will compare measurements between older adults with hypertension 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 * Have their blood pressure, oxygen saturation, ECG and heart rate variability measured using 24-hour advanced actigraphy in three repeated assessments * Provide samples of urine and blood biomarkers in three repeated assessments.

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Key information

Conditions

Hypertension Arterial 65 Years Older Cardiovascular Diseases Hypertension Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical School, University of Cyprus, Nicosia, Cyprus

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥65 years
  • Living in Barcelona (Spain) or Nicosia (Cyprus) metropolitan areas
  • Have a physician's diagnosis of arterial hypertension
  • Receive daily anti-hypertensive medication
  • Clinically stable

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, diabetes mellitus type 2 (DM2), inflammatory diseases, renal failure, or active cancer)
  • Illicit drugs abuse
  • Alcohol abuse
  • Psychiatric disorders
  • Severe mental disability that interferes with answering questions or following instructions

Treatment and study plan

Heat intervention

Behavioral

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 intervention

Behavioral

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

Primary outcomes

  1. Percentage dipping in night-time systolic blood pressure (SBP)

    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).

    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.

Secondary outcomes

  1. 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.

  2. Sleep-wake pattern

    Time frame: Daily measurements - for the whole duration of follow-up (2 months)

    Sleep-wake pattern will be estimated based on measurements of movement and heart rate obtained from a wearable device (wristband).

  3. 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).]

    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.

  4. 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)

    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).

  5. Daily heart rate

    Time frame: Daily measurements - for the whole duration of follow-up (2 months)

    Heart rate measurements taken throughout the day by a wearable device (wristband).

  6. 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 will be measured using ECG.

  7. 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)

    Heart rate variability will be measured using ECG.

  8. The personal ambient temperature profile of all participants

    Time frame: Daily measurements - for the whole duration of follow-up (2 months)

    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).

  9. Wet-bulb globe temperature (WGBT)

    Time frame: Daily measurements - for the whole duration of follow-up (2 months)

    Wet-bulb globe temperature (WGBT) will be assessed as a thermal stress indicator.

  10. Humidity

    Time frame: Daily measurements - for the whole duration of follow-up (2 months)

    Humidity will be measured using iButton.

  11. Indoor concentration levels of PM2.5 and PM10 at residence

    Time frame: Daily measurements - for the whole duration of follow-up (2 months)

    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).

  12. Number of daily steps

    Time frame: Daily measurements - for the whole duration of follow-up (2 months)

    Physical activity will be measured as number of daily steps, throughout the day by a wearable device (wristband).

  13. Serum C-reactive Protein (CRP) levels

    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 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).

  14. 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 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).

  15. 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 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).

  16. 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 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).

  17. 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 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).

  18. Serum Osmolality

    Time frame: Serum osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    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).

  19. 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 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).

  20. 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 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).

  21. 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 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).

  22. Urine Osmolality

    Time frame: Urine osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    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).

  23. 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).

    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).

  24. 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).

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Panayiotis Kouis, PhD

CONTACT

[email protected]

+35722895243

Panayiotis Yiallouros, Professor

CONTACT

[email protected]

+35722895212

Sponsors and collaborators

Lead sponsor

University of Cyprus

Other

Collaborators

  • FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA
  • PANCYPRIAN FEDERATION OF LABOUR

Registry information

Official study title

Innovative Solutions Across the MEDiterranean for Mitigation of Climate Change-related heaLth rIsks and Enhancing Health systeM Resilience

Acronym: ISMED CLIM OH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 26, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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