Hypertension ArterialISMED CLIM OHNCT07606859
Mitigation of Health Effects in Older Adults With Hypertension by Reducing Exposure to Heat and Air Pollution
A study testing Heat intervention and Heat and air pollution mitigation intervention in people with Hypertension Arterial and 65 Years Older, run by University of Cyprus at 2 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 older adults with hypertension. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension Arterial, 65 Years Older
- What is being tested?
- Heat intervention and Heat and air pollution mitigation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2026to 31 Jul 2027
- Phase
- Interventional
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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, diabetes mellitus type 2 (DM2), inflammatory diseases, renal failure, or active cancer)
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- Illicit drugs abuse
- Alcohol abuse
- Psychiatric disorders
- Severe mental disability that interferes with answering questions or following instructions
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Cyprus1 site, 1 recruiting
- Recruiting
Medical School, University of Cyprus
Nicosia
Panayiotis Kouis, PhD, +35722895243, kouis.panayiotis@ucy.ac.cy
Spain1 site, 1 recruiting
- Recruiting
Vall d'Hebron Institut de Recerca (VHIR)
Barcelona
Aida Ribera, PhD, +34 93 2594263, ariberas@perevirgili.cat
Cristina Vert Roca, PhD, +34 93 2594263, cristina.vert@vhir.org
About this study
Official title: Innovative Solutions Across the MEDiterranean for Mitigation of Climate Change-related heaLth rIsks and Enhancing Health systeM Resilience
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:
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) 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.
- Conditions
- Hypertension Arterial, 65 Years Older
- Being tested
- Heat intervention, Heat and air pollution mitigation intervention
- Keywords
- Hypertension, Adults 65 years and older, Intervention, Personal Ambient Temperature Exposure, Indoor air quality, Indoor air purification
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat interventionBehavioural
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 interventionBehavioural
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 for high temperatures nor recommendations for mitigation of heat-related health effects. |
| Heat intervention - Personal Alerts and Specific Recommendations | Experimental | 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. Receives: Behavioral: 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: Behavioral: Heat and air pollution mitigation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Secondary outcomes (24)
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)
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 measurements - for the whole duration of follow-up (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)
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 (WGBT) 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 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).
Measured: 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).
Measured: 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).
Measured: 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).
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).
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 posted26 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 (4)Papers the sponsor has linked to this study.
- Other trials for Hypertension ArterialStudies 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
- FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA, PANCYPRIAN FEDERATION OF LABOUR
- 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
- NCT07606859
- Sponsor's protocol ID
- 101156653.LL3.OH
- Other IDs
- 101156653
- Acronym
- ISMED CLIM OH
- Status last verified
- Jun 2026
- First submitted
- 19 May 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
Hu J, Xue X, Xiao M, Wang W, Gao Y, Kan H, Ge J, Cui Z, Chen R. The acute effects of particulate matter air pollution on ambulatory blood pressure: A multicenter analysis at the hourly level. Environ Int. 2021 Dec;157:106859. doi: 10.1016/j.envint.2021.106859. Epub 2021 Sep 9.
PubMed 34509047Modesti PA, Morabito M, Bertolozzi I, Massetti L, Panci G, Lumachi C, Giglio A, Bilo G, Caldara G, Lonati L, Orlandini S, Maracchi G, Mancia G, Gensini GF, Parati G. Weather-related changes in 24-hour blood pressure profile: effects of age and implications for hypertension management. Hypertension. 2006 Feb;47(2):155-61. doi: 10.1161/01.HYP.0000199192.17126.d4. Epub 2005 Dec 27.
PubMed 16380524Kario K, Hoshide S, Mizuno H, Kabutoya T, Nishizawa M, Yoshida T, Abe H, Katsuya T, Fujita Y, Okazaki O, Yano Y, Tomitani N, Kanegae H; JAMP Study Group. Nighttime Blood Pressure Phenotype and Cardiovascular Prognosis: Practitioner-Based Nationwide JAMP Study. Circulation. 2020 Nov 10;142(19):1810-1820. doi: 10.1161/CIRCULATIONAHA.120.049730. Epub 2020 Nov 2.
PubMed 33131317Tabara Y, Matsumoto T, Murase K, Nagashima S, Hirai T, Kosugi S, Nakayama T, Wakamura T, Chin K, Matsuda F; and the Nagahama study group. Seasonal variation in nocturnal home blood pressure fall: the Nagahama study. Hypertens Res. 2018 Mar;41(3):198-208. doi: 10.1038/s41440-017-0003-3. Epub 2018 Jan 30.
PubMed 29382900