Protective Cooling Measures to Safeguard Elderly People From Dangerous Summer Heat
Primary Purpose
Hyperthermia, Heat; Weather, Aging
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
No cooling (control)
Recommended cooling
Hybrid cooling
Sponsored by
About this trial
This is an interventional basic science trial for Hyperthermia focused on measuring Heat wave, Cooling center, Heat strain, Cardiovascular strain, Heat and health protection, Extreme heat events, Thermal comfort
Eligibility Criteria
Inclusion Criteria:
- Adult aged 60-85 years
- Male or female
- Body mass index < 35 kg/m2
- For participants with type 2 diabetes: at least one year lapsed since diagnosis and hemoglobin A1c 6.0-10.5%.
- For participants with hypertension: at least one year lapsed since diagnosis or average resting blood pressure >140 systolic or >90 diastolic
Exclusion Criteria:
- Currently smoking or quit <5 years ago
- Moderate or serious medical conditions (other than Type 2 diabetes or high blood pressure), particularly those known to influence physiological responses to heat exposure (e.g., diagnosed heart disease, neurological disorders)
- Heat adapted due to repeated exposure to hot environments (use sauna, recent travel to hot climates, other)
- For participants with type 2 diabetes: "Brittle" diabetes: unpredictable hypo- & hyperglycemia. Severe cardiovascular autonomic or peripheral neuropathy (guidelines.diabetes.ca/cpg)
Sites / Locations
- University of Ottawa
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Extreme heat event simulation + no cooling (control)
Extreme heat event simulation + recommended cooling
Extreme heat event simulation + hybrid cooling
Arm Description
Adults aged 60-85 years with or without type 2 diabetes and/or hypertension
Adults aged 60-85 years with or without type 2 diabetes and/or hypertension
Adults aged 60-85 years with or without type 2 diabetes and/or hypertension
Outcomes
Primary Outcome Measures
Core temperature (peak)
Peak rectal temperature measured during the 8-hour heat exposure.
Core temperature (AUC)
Rectal temperature will be measured continuously throughout each exposure and the area under the curve will be calculated.
Secondary Outcome Measures
Heart rate temperature (peak)
Peak rectal temperature measured during the 8-hour heat exposure.
Heart rate (AUC)
Heart rate will be measured continuously throughout each exposure and the area under the curve will be calculated.
Mean skin temperature
Mean skin temperature calculated as a weighted average of skin temperatures at 8 body regions.
Arterial blood pressures
Systolic and diastolic pressures measured in triplicate.
SDNN
Standard deviation of normal-to-normal R-R intervals measured via 3-lead ECG.
RMSSD
Root mean squared standard deviation of normal-to-normal R-R intervals measured via 3-lead ECG.
Rate pressure product
Rate pressure product calculated as systolic blood pressure x heart rate.
Body fluid loss
Body fluid loss calculated as a change in body weight from pre-exposure values (corrected for food intake and deification).
Stand test: 30:15 ratio
30:15 ratio calculated as the ratio of the RR interval measured after 30 heart beats following standing from a supine position to that measured after 15 heart beats.
Stand test: Systolic response to standing
Fall in systolic blood pressure after standing from a supine position.
Baroreflex sensitivity
Baroreflex sensitivity determined during cyclic stand-squat manoeuvres.
Change in plasma volume
Change in plasma volume calculated from venous blood samples (Dill and Costill technique)
Full Information
NCT ID
NCT05274009
First Posted
February 25, 2022
Last Updated
October 19, 2022
Sponsor
University of Ottawa
1. Study Identification
Unique Protocol Identification Number
NCT05274009
Brief Title
Protective Cooling Measures to Safeguard Elderly People From Dangerous Summer Heat
Official Title
Evaluating the Efficacy of Cooling Centres for Limiting Heat Strain in Elderly Adults During Extreme Heat Events
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ottawa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
With the increasing incidence and severity of extreme heat events accompanying climate change, there is an urgent need for sustainable cooling strategies to protect heat-vulnerable older adults, who are at increased risk of adverse health events during heat stress. Health agencies including the World Health Organization, the United States Centers for Disease Control and Prevention, and Health Canada currently recommend visiting a cooling centre or other air-conditioned location for 1-3 hours per day during extreme heat events to mitigate hyperthermia and strain on the cardiovascular system and therefore the risk adverse health events. However, our recent trial shows that while brief air-conditioning exposure is effective for reducing body temperature and cardiovascular burden in healthy older adults, the physiological impacts of cooling abate quickly following return to the heat. The purpose of this project is therefore to assess whether shorter but more frequent air-conditioning exposure provides more effective cooling than current recommendations (a single 1-3-hour cooling bout) in older adults with or without common chronic health conditions associated with increased vulnerability to extreme heat. This will be accomplished by evaluating physiological strain in older adults with and without diabetes and/or hypertension exposed for 8 hours to conditions reflective of extreme heat events in temperate, continental climates (35°C, 60% relative humidity). Participants will complete 3 separate simulated heat event exposures: i) a control trial (no cooling throughout the 8-hour heat event); ii) a recommended cooling trial (3 hours of heat exposure followed by 2 hours cooling); and iii) a hybrid cooling trial (2 hours of heat exposure followed by 1 hour cooling, another 2 hours heat exposure followed by 1 hour cooling, and a final 2-hour heat exposure).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthermia, Heat; Weather, Aging, Type2 Diabetes, Hypertension, Heat Stress
Keywords
Heat wave, Cooling center, Heat strain, Cardiovascular strain, Heat and health protection, Extreme heat events, Thermal comfort
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participant will complete 3 simulated extreme heat event exposures in random order: i) no cooling center intervention (control); ii) recommended cooling center intervention (1 x 2-hours of brief air-conditioning); and iii) hybrid cooling center intervention (2 x 1-hour interspersed brief air-conditioning)
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will be informed of the study interventions before providing informed consent but will be blinded to the specific trial condition at each of the 3 laboratory visits (control, recommended cooling, hybrid cooling). Data will be blinded prior to analysis.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Extreme heat event simulation + no cooling (control)
Arm Type
Experimental
Arm Description
Adults aged 60-85 years with or without type 2 diabetes and/or hypertension
Arm Title
Extreme heat event simulation + recommended cooling
Arm Type
Experimental
Arm Description
Adults aged 60-85 years with or without type 2 diabetes and/or hypertension
Arm Title
Extreme heat event simulation + hybrid cooling
Arm Type
Experimental
Arm Description
Adults aged 60-85 years with or without type 2 diabetes and/or hypertension
Intervention Type
Other
Intervention Name(s)
No cooling (control)
Intervention Description
Participants are exposed to 35°C, 60% relative humidity for 8 hours.
Intervention Type
Other
Intervention Name(s)
Recommended cooling
Intervention Description
Participants are exposed to 35°C, 60% relative humidity for 3 hours, are then moved to an air-conditioned room for 2 hours (~23°C, ~50% relative humidity), and then return to the heat for a final 3 hours.
Intervention Type
Other
Intervention Name(s)
Hybrid cooling
Intervention Description
Participants are exposed to 35°C, 60% relative humidity for 2 hours, are moved to an air-conditioned room for 1 hour (~23°C, ~50% relative humidity), return to the heat for 2 hours, move back to the air-conditioned room for 1 hour, and then return to the heat for a final 2 hours
Primary Outcome Measure Information:
Title
Core temperature (peak)
Description
Peak rectal temperature measured during the 8-hour heat exposure.
Time Frame
8-hour heat exposure
Title
Core temperature (AUC)
Description
Rectal temperature will be measured continuously throughout each exposure and the area under the curve will be calculated.
Time Frame
8-hour heat exposure
Secondary Outcome Measure Information:
Title
Heart rate temperature (peak)
Description
Peak rectal temperature measured during the 8-hour heat exposure.
Time Frame
8-hour heat exposure
Title
Heart rate (AUC)
Description
Heart rate will be measured continuously throughout each exposure and the area under the curve will be calculated.
Time Frame
8-hour heat exposure
Title
Mean skin temperature
Description
Mean skin temperature calculated as a weighted average of skin temperatures at 8 body regions.
Time Frame
Before and continuously throughout each 8 hour exposure
Title
Arterial blood pressures
Description
Systolic and diastolic pressures measured in triplicate.
Time Frame
Every hour during the 8-hour heat exposure
Title
SDNN
Description
Standard deviation of normal-to-normal R-R intervals measured via 3-lead ECG.
Time Frame
Every hour during the 8-hour heat exposure
Title
RMSSD
Description
Root mean squared standard deviation of normal-to-normal R-R intervals measured via 3-lead ECG.
Time Frame
Every hour during the 8-hour heat exposure
Title
Rate pressure product
Description
Rate pressure product calculated as systolic blood pressure x heart rate.
Time Frame
Every hour during the 8-hour heat exposure
Title
Body fluid loss
Description
Body fluid loss calculated as a change in body weight from pre-exposure values (corrected for food intake and deification).
Time Frame
Every hour during the 8-hour heat exposure
Title
Stand test: 30:15 ratio
Description
30:15 ratio calculated as the ratio of the RR interval measured after 30 heart beats following standing from a supine position to that measured after 15 heart beats.
Time Frame
Prior to and following the 8-hour heat exposure
Title
Stand test: Systolic response to standing
Description
Fall in systolic blood pressure after standing from a supine position.
Time Frame
Prior to and following the 8-hour heat exposure
Title
Baroreflex sensitivity
Description
Baroreflex sensitivity determined during cyclic stand-squat manoeuvres.
Time Frame
Prior to and following the 8-hour heat exposure
Title
Change in plasma volume
Description
Change in plasma volume calculated from venous blood samples (Dill and Costill technique)
Time Frame
Prior to and following the 8-hour heat exposure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult aged 60-85 years
Male or female
Body mass index < 35 kg/m2
For participants with type 2 diabetes: at least one year lapsed since diagnosis and hemoglobin A1c 6.0-10.5%.
For participants with hypertension: at least one year lapsed since diagnosis or average resting blood pressure >140 systolic or >90 diastolic
Exclusion Criteria:
Currently smoking or quit <5 years ago
Moderate or serious medical conditions (other than Type 2 diabetes or high blood pressure), particularly those known to influence physiological responses to heat exposure (e.g., diagnosed heart disease, neurological disorders)
Heat adapted due to repeated exposure to hot environments (use sauna, recent travel to hot climates, other)
For participants with type 2 diabetes: "Brittle" diabetes: unpredictable hypo- & hyperglycemia. Severe cardiovascular autonomic or peripheral neuropathy (guidelines.diabetes.ca/cpg)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Glen P Kenny, PhD
Phone
6135625800
Ext
4282
Email
gkenny@uottawa.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Robert D Meade, PhD
Phone
6136986071
Email
rmead015@uottawa.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glen P Kenny, PhD
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald J Sigal, MD, MPH
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert D Meade, PhD
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N6N5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glen P Kenny, PhD
Phone
6135625800
Ext
4282
Email
gkenny@uottawa.ca
First Name & Middle Initial & Last Name & Degree
Robert D Meade, PhD
Phone
6136986071
Email
rmead015@uottawa.ca
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified participant data will be available from Dr. Kenny upon reasonable request and signed access agreement.
IPD Sharing Time Frame
After study completion
IPD Sharing Access Criteria
Reasonable request and signed access agreement
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Protective Cooling Measures to Safeguard Elderly People From Dangerous Summer Heat
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