- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06850025
Heat Waves, Urban Heat Islands, and Wellbeing and Health: a Mobile Sensing Approach (H3Sensing)
Heat Waves, Urban Heat Islands, and Wellbeing and Health: a Mobile Sensing Approach (H3Sensing)
The first objective of H3Sensing is to investigate outdoor environmental, building, dwelling, situational, and behavioral determinants of objectively assessed personal heat stress over daily movements during warm periods.
The second aim is to investigate how these heat stress determinants and momentary and cumulated heat stress itself are related to physiological indicators of heat stress, sleep, thermal discomfort, and well-being.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Basile Chaix, PhD
- Phone Number: 00 33 6 68 30 00 55
- Email: basile.chaix@iplesp.upmc.fr
Study Locations
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Paris, France, 75012
- Recruiting
- Pierre Louis Institute of Epidemiology and Public Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population is a sample recruited through internet advertisement, residing in the Grand Paris, in warmer or cooler areas and in different types of dwellings.
Quota sampling is applied in this research.
Description
Inclusion Criteria:
- Person aged between 30-64 years
- Person living in the Ile-de-France
Exclusion Criteria:
- Person subject to a legal protection measure (safeguarding of justice, curatorship, guardianship)
- Person deprived of liberty by a judicial or administrative decision,
- Person with a major functional limitation affecting their spatial mobility
- Person unable to complete a questionnaire
- Known cardiovascular (other than hypertension) or cerebrovascular disease: personal history of myocardial infarction, rhythm disorders or stroke
- People wearing a pacemaker or other implanted device, due to the risk of interference
- Pregnant or breastfeeding woman
- Person working night or shift
- Person with a definite plan to move in the coming months (before the second collection during summer)
- Person who initially refuses to participate in this second wave of the study
- Person working outside the Ile de France
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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180 participants from the Grand Paris area
180 participants recruited in the Grand Paris area through web and social network advertisements.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ambulatory blood pressure
Time Frame: Measurement over 4 days, in two separate waves of 4 days
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Ambulatory blood pressure measured with a bracelet
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Measurement over 4 days, in two separate waves of 4 days
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Skin temperature
Time Frame: Measurement over 4 days, in two separate waves of 4 days
|
It is measured with a bracelet, in degrees.
It provides important information on the interaction of the body with the heat environment.
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Measurement over 4 days, in two separate waves of 4 days
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Accelerometry outcomes: total sleep time, sleep efficiency, and wake after sleep onset
Time Frame: These outcomes are collected for 5 successive nights in each of the two periods.
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These three accelerometry outcomes will be derived from a bracelet.
Total sleep time is in hours and minutes.
Sleep efficiency is a percentage.
Wake after sleep onset is in minutes.
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These outcomes are collected for 5 successive nights in each of the two periods.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Personal heat stress measured with the Universal Thermal Climate Index
Time Frame: Measured continuously over 2 waves of 4 days
|
This secondary outcome will be measured with a unique indicator called the Universal Thermal Climate Index.
Although it is based on 4 parameters measured with wearable sensors (air temperature, humidity, radiant temperature, and air flow), it is measured in degree Celsius (so with a unique unit).
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Measured continuously over 2 waves of 4 days
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- C22-60
- 2022-A02108-35 (Other Identifier: IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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