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

NCT07606859 | Recruiting DMC

• 2 other identifiers: 101156653.LL3.OH101156653
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 2

Brief 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. 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.

Conditions

Hypertension Arterial; 65 Years Older

Keywords

Hypertension; Adults 65 years and older; Intervention; Personal Ambient Temperature Exposure; Indoor air quality; Indoor air purification

Outcome Measures

Primary Outcomes (1)

• 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.

  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 PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)

• Sleep-wake pattern

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

• Sleep-Wake self-reported evaluation

  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 assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)

• Daily heart rate

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

Study Arms (3)

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.

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.

Behavioral: Heat and air pollution mitigation intervention

Interventions

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 intervention - Personal Alerts and Specific Recommendations

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

Heat and air pollution intervention - Group Alerts, Recommendations and Air Cleaners

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cyprus: lead
• FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA: collaborator
• PANCYPRIAN FEDERATION OF LABOUR: collaborator

Study Sites (2)

Medical School, University of Cyprus

Nicosia, Cyprus

RECRUITING

Vall d'Hebron Institut de Recerca (VHIR)

Barcelona, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 34509047 BACKGROUND

• Modesti 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.

  PMID: 16380524 BACKGROUND

• Kario 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.

  PMID: 33131317 BACKGROUND

• Tabara 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.

  PMID: 29382900 BACKGROUND

Related Links

• Innovative Solutions for Climate Resilience in the Mediterranean ( ISMED-CLIM) project

MeSH Terms

Conditions

Hypertension

Interventions

Hot Temperature

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Panayiotis Yiallouros, Professor

  University of Cyprus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panayiotis Yiallouros, Professor

CONTACT

+35722895212; yiallouros.panayiotis@ucy.ac.cy

Panayiotis Kouis, PhD

CONTACT

+35722895243; kouis.panayiotis@ucy.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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)

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); CY (1)