Mitigation of Health Effects in Older Adults With Hypertension by Reducing Exposure to Heat and Air Pollution (ISMED CLIM OH)
3 czerwca 2026 zaktualizowane przez: Panayiotis Yiallouros, University of Cyprus
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:
- 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.
Przegląd badań
Status
Status
Rekrutacyjny
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Interwencyjne
Zapisy (Szacowany)
Zapisy
102
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Panayiotis Yiallouros, Professor
- Numer telefonu: +35722895212
- E-mail: yiallouros.panayiotis@ucy.ac.cy
Kopia zapasowa kontaktu do badania
- Nazwa: Panayiotis Kouis, PhD
- Numer telefonu: +35722895243
- E-mail: kouis.panayiotis@ucy.ac.cy
Lokalizacje studiów
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Nicosia, Cypr
- Rekrutacyjny
- Medical School, University of Cyprus
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Kontakt:
- Panayiotis Kouis, PhD
- Numer telefonu: +35722895243
- E-mail: kouis.panayiotis@ucy.ac.cy
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Barcelona, Hiszpania
- Rekrutacyjny
- Vall d'Hebron Institut de Recerca (VHIR)
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Kontakt:
- Aida Ribera, PhD
- Numer telefonu: +34 93 2594263
- E-mail: ariberas@perevirgili.cat
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Kontakt:
- Cristina Vert Roca, PhD
- Numer telefonu: +34 93 2594263
- E-mail: cristina.vert@vhir.org
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
3
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Brak interwencji: Control group
Subjects in this arm will receive no alerts for high temperatures nor recommendations for mitigation of heat-related health effects.
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Eksperymentalny: Heat intervention - Personal Alerts and Specific Recommendations
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.
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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.
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Eksperymentalny: Heat and air pollution intervention - Group Alerts, Recommendations and Air Cleaners
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.
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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
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage dipping in night-time systolic blood pressure (SBP)
Ramy czasowe: 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).
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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.
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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).
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Pittsburgh Sleep Quality Index (PSQI)
Ramy czasowe: The PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)
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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.
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The PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)
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Sleep-wake pattern
Ramy czasowe: Daily measurements - for the whole duration of follow-up (2 months)
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Sleep-wake pattern will be estimated based on measurements of movement and heart rate obtained from a wearable device (wristband).
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Daily measurements - for the whole duration of follow-up (2 months)
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Sleep-Wake self-reported evaluation
Ramy czasowe: The sleep-wake self-reported evaluation will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
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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.
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The sleep-wake self-reported evaluation will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
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Hamilton Anxiety Rating Scale
Ramy czasowe: The Hamilton Anxiety Rating Scale will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)
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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).
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The Hamilton Anxiety Rating Scale will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)
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Daily heart rate
Ramy czasowe: Daily measurements - for the whole duration of follow-up (2 months)
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Heart rate measurements taken throughout the day by a wearable device (wristband).
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Daily measurements - for the whole duration of follow-up (2 months)
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Heart Rate
Ramy czasowe: Heart Rate will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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Heart rate will be measured using ECG.
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Heart Rate will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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Heart Rate Variability
Ramy czasowe: The heart rate variability will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)
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Heart rate variability will be measured using ECG.
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The heart rate variability will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)
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The personal ambient temperature profile of all participants
Ramy czasowe: Daily measurements - for the whole duration of follow-up (2 months)
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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).
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Daily measurements - for the whole duration of follow-up (2 months)
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Wet-bulb globe temperature (WGBT)
Ramy czasowe: Daily measurements - for the whole duration of follow-up (2 months)
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Wet-bulb globe temperature (WGBT) will be assessed as a thermal stress indicator.
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Daily measurements - for the whole duration of follow-up (2 months)
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Humidity
Ramy czasowe: Daily measurements - for the whole duration of follow-up (2 months)
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Humidity will be measured using iButton.
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Daily measurements - for the whole duration of follow-up (2 months)
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Indoor concentration levels of PM2.5 and PM10 at residence
Ramy czasowe: Daily measurements - for the whole duration of follow-up (2 months)
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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).
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Daily measurements - for the whole duration of follow-up (2 months)
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Number of daily steps
Ramy czasowe: Daily measurements - for the whole duration of follow-up (2 months)
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Physical activity will be measured as number of daily steps, throughout the day by a wearable device (wristband).
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Daily measurements - for the whole duration of follow-up (2 months)
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Serum C-reactive Protein (CRP) levels
Ramy czasowe: Serum levels of CRP will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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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).
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Serum levels of CRP will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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Serum Urea Levels
Ramy czasowe: Serum levels of urea will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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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).
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Serum levels of urea will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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Serum Creatinine Levels
Ramy czasowe: Serum levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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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).
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Serum levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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Serum Sodium levels
Ramy czasowe: Serum levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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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).
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Serum levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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Serum Potassium levels
Ramy czasowe: Serum levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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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).
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Serum levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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Serum Osmolality
Ramy czasowe: Serum osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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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).
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Serum osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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Urine Creatinine Levels
Ramy czasowe: Urine levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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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).
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Urine levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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Urine Sodium levels
Ramy czasowe: Urine levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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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).
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Urine levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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Urine Potassium levels
Ramy czasowe: Urine levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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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).
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Urine levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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Urine Osmolality
Ramy czasowe: Urine osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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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).
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Urine osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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Hair cortisol levels
Ramy czasowe: Hair cortisol levels will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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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).
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Hair cortisol levels will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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Saliva alpha-amylase levels
Ramy czasowe: Saliva levels of alpha-amylase will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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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).
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Saliva levels of alpha-amylase will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: Panayiotis Yiallouros, Professor, University of Cyprus
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
1 maja 2026
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
31 lipca 2027
Ukończenie studiów (Szacowany)
Ukończenie studiów
31 lipca 2027
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
19 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
19 maja 2026
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
26 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
5 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
3 czerwca 2026
Ostatnia weryfikacja
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 101156653.LL3.OH
- 101156653 (Inny numer grantu/finansowania: European Commission)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .