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Mitigation of Health Effects in Older Adults With Hypertension by Reducing Exposure to Heat and Air Pollution (ISMED CLIM OH)

3 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

102

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Chipre
      • Nicosia, Chipre
        • Recrutamento
        • Medical School, University of Cyprus
        • Contato:
  • Espanha
      • Barcelona, Espanha
        • Recrutamento
        • Vall d'Hebron Institut de Recerca (VHIR)
        • Contato:
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Control group
Subjects in this arm will receive no alerts for high temperatures nor recommendations for mitigation of heat-related health effects.
Experimental: 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.
Comportamental: Heat 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.
Experimental: 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.
Comportamental: Heat and air pollution mitigation intervention
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage dipping in night-time systolic blood pressure (SBP)
Prazo: 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.
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).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Pittsburgh Sleep Quality Index (PSQI)
Prazo: 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.
The PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)
Sleep-wake pattern
Prazo: 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).
Daily measurements - for the whole duration of follow-up (2 months)
Sleep-Wake self-reported evaluation
Prazo: 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.
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
Prazo: 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).
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
Prazo: Daily measurements - for the whole duration of follow-up (2 months)
Heart rate measurements taken throughout the day by a wearable device (wristband).
Daily measurements - for the whole duration of follow-up (2 months)
Heart Rate
Prazo: 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.
Heart Rate will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Heart Rate Variability
Prazo: 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.
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
Prazo: 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).
Daily measurements - for the whole duration of follow-up (2 months)
Wet-bulb globe temperature (WGBT)
Prazo: Daily measurements - for the whole duration of follow-up (2 months)
Wet-bulb globe temperature (WGBT) will be assessed as a thermal stress indicator.
Daily measurements - for the whole duration of follow-up (2 months)
Humidity
Prazo: Daily measurements - for the whole duration of follow-up (2 months)
Humidity will be measured using iButton.
Daily measurements - for the whole duration of follow-up (2 months)
Indoor concentration levels of PM2.5 and PM10 at residence
Prazo: 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).
Daily measurements - for the whole duration of follow-up (2 months)
Number of daily steps
Prazo: 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).
Daily measurements - for the whole duration of follow-up (2 months)
Serum C-reactive Protein (CRP) levels
Prazo: 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).
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
Prazo: 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).
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
Prazo: 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).
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
Prazo: 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).
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
Prazo: 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).
Serum levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Serum Osmolality
Prazo: 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).
Serum osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine Creatinine Levels
Prazo: 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).
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
Prazo: 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).
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
Prazo: 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).
Urine levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Urine Osmolality
Prazo: 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).
Urine osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).
Hair cortisol levels
Prazo: 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).
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
Prazo: 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).
Saliva levels of alpha-amylase will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Cyprus

Colaboradores

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

Investigadores

  • Investigador principal: Panayiotis Yiallouros, Professor, University of Cyprus

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de maio de 2026

Conclusão Primária (Estimado)

31 de julho de 2027

Conclusão do estudo (Estimado)

31 de julho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

19 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de maio de 2026

Primeira postagem (Real)

26 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 101156653.LL3.OH
  • 101156653 (Número de outro subsídio/financiamento: European Commission)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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