Heat ExposureNCT06584903
Safe Indoor Temperature Limit for Fans
A study testing Temperature Ramp Protocol in people with Heat Exposure and Healthy, run by Lakehead University at 1 site in Canada.
Trial summary
Extreme heat events are a significant global threat to health and wellbeing, and result in more morbidity and mortality than all other natural disasters combined. Thus, a key priority is identifying effective and accessible heat resilience solutions to protect individuals from the potentially fatal consequences of… Read more about this study
- Who is it for?
- Ages 19 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat Exposure, Healthy, Young Adults
- What is being tested?
- Temperature Ramp Protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jan 2024to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index less than 30
- male or female
- ability to tolerate hot environments for a prolonged period (e.g. \>2 h)
Who cannot join
- Any respiratory disease
- Any cardiovascular disease, including hypertension
- Diabetes
- not currently on any medication (except oral contraceptives)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fan Use During Extreme Heat: Safe Thermal Limits
Extreme heat events are a significant global threat to health and wellbeing, and result in more morbidity and mortality than all other natural disasters combined. Thus, a key priority is identifying effective and accessible heat resilience solutions to protect individuals from the potentially fatal consequences of heat stress. Within a range of ambient conditions, a fan has been recognized a low-cost heat resilience solution. However, when ambient temperatures exceed skin temperatures (e.g., above 35°C), a fan will incur greater dry heat gain which may be counterbalanced with evaporation of sweat from the skin surface. However, at a critical indoor temperature, the rate of heat gain will exceed the rate of evaporation resulting in net heat gain. The critical indoor temperature has yet to be determined. The purpose of this present study is to identify the indoor temperature at which a fan results in greater cardiovascular and thermal strain relative to still air in young adults using a simulated heat wave scenario of a warming room.
- Conditions
- Heat Exposure, Healthy, Young Adults, Fans
- Being tested
- Temperature Ramp Protocol
- Keywords
- indoor temperature, core temperature, heart rate, electric fans, cardiovascular strain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature Ramp ProtocolOther
Following a 45 minute baseline in 37°C seated on a chair, the indoor temperature in the climate-controlled room increased from 37°C to 47°C at ~0.06°C/min (relative humidity ~26%) over 180 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Still air | Placebo comparator | still air condition with no supplemental air flow Receives: Other: Temperature Ramp Protocol |
| Electric fan | Experimental | Force air flow with a 46 cm 3-blade fan positioned 1.2 m anterior to the participants chest Receives: Other: Temperature Ramp Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Measured with an electrocardiogram-gated automated cuff
Measured: At baseline (e.g. 0 minutes), and every 10 minutes of exposure up to 180 minutes
Rate Pressure Product
Measured: At baseline (e.g. 0 minutes), and every 10 minutes of exposure up to 180 minutes
Heart Rate
Measured with a 3-lead electrocardiogram
Measured: At baseline (e.g. 0 minutes), and every minute for the 180 minute experimental trial
Skin Temperature
Measured at 4 skin locations (chest, arm, thigh, and calf) using wireless iButtons affixed to the skin with surgical tape
Measured: At baseline (e.g. 0 minutes), and every minute for the 180 minute experimental trial
Core Temperature
rectal temperature measured with a pediatric grade thermistor probe
Measured: At baseline (e.g. 0 minutes), and every minute for the 180 minute experimental trial
Whole-Body Sweat Rate
Net difference in body mass (pre versus post) using a balance scale placed below the chair of the participant
Measured: At baseline (e.g. 0 minutes), and every minute for the 180 minute experimental trial
Secondary outcomes (2)
Thermal Sensation
visual analog scale
Measured: At baseline (e.g. 0 minutes), and every 10 minutes for the 180 minute experimental trial
Thermal comfort
visual analog scale
Measured: Assessed at baseline (e.g. 0 minutes), and every 10 minutes for the 180 minute experimental trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start20 Jan 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakehead University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Ravanelli, Lakehead University
- Investigators
- Nicholas Ravanelli, PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584903
- Sponsor's protocol ID
- 26897
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified participant data supporting the findings of this study will be made freely available on the Open Science Framework Repository.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fan Use During Extreme Heat: Safe Thermal Limits
- ClinicalTrials.gov ID
- NCT06584903
- Acronym / sponsor ID
- 26897
- Conditions
- Heat Exposure, Healthy, Young Adults, Fans
- Keywords
- indoor temperature, core temperature, heart rate, electric fans, cardiovascular strain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lakehead UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Extreme heat events are a significant global threat to health and wellbeing, and result in more morbidity and mortality than all other natural disasters combined. Thus, a key priority is identifying effective and accessible heat resilience solutions to protect individuals from the potentially fatal consequences of heat stress. Within a range of ambient conditions, a fan has been recognized a low-cost heat resilience solution. However, when ambient temperatures exceed skin temperatures (e.g., above 35°C), a fan will incur greater dry heat gain which may be counterbalanced with evaporation of sweat from the skin surface. However, at a critical indoor temperature, the rate of heat gain will exceed the rate of evaporation resulting in net heat gain. The critical indoor temperature has yet to be determined. The purpose of this present study is to identify the indoor temperature at which a fan results in greater cardiovascular and thermal strain relative to still air in young adults using a simulated heat wave scenario of a warming room.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Still air | Placebo comparator | Other: Temperature Ramp Protocolstill air condition with no supplemental air flow |
| Electric fan | Experimental | Other: Temperature Ramp ProtocolForce air flow with a 46 cm 3-blade fan positioned 1.2 m anterior to the participants chest |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index less than 30
- male or female
- ability to tolerate hot environments for a prolonged period (e.g. \>2 h)
Key exclusion criteria (4 listed)
- Any respiratory disease
- Any cardiovascular disease, including hypertension
- Diabetes
- not currently on any medication (except oral contraceptives)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temperature Ramp ProtocolFollowing a 45 minute baseline in 37°C seated on a chair, the indoor temperature in the climate-controlled room increased from 37°C to 47°C at ~0.06°C/min (relative humidity ~26%) over 180 minutes. | Other | Electric fan, Still air |
Primary outcome
Blood Pressure
Time frame: At baseline (e.g. 0 minutes), and every 10 minutes of exposure up to 180 minutes
Measured with an electrocardiogram-gated automated cuff
Rate Pressure Product
Time frame: At baseline (e.g. 0 minutes), and every 10 minutes of exposure up to 180 minutes
Heart Rate
Time frame: At baseline (e.g. 0 minutes), and every minute for the 180 minute experimental trial
Measured with a 3-lead electrocardiogram
Skin Temperature
Time frame: At baseline (e.g. 0 minutes), and every minute for the 180 minute experimental trial
Measured at 4 skin locations (chest, arm, thigh, and calf) using wireless iButtons affixed to the skin with surgical tape
Core Temperature
Time frame: At baseline (e.g. 0 minutes), and every minute for the 180 minute experimental trial
rectal temperature measured with a pediatric grade thermistor probe
Whole-Body Sweat Rate
Time frame: At baseline (e.g. 0 minutes), and every minute for the 180 minute experimental trial
Net difference in body mass (pre versus post) using a balance scale placed below the chair of the participant
2 secondary outcomes
Thermal Sensation
Time frame: At baseline (e.g. 0 minutes), and every 10 minutes for the 180 minute experimental trial
Thermal comfort
Time frame: Assessed at baseline (e.g. 0 minutes), and every 10 minutes for the 180 minute experimental trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. All deidentified participant data supporting the findings of this study will be made freely available on the Open Science Framework Repository.
Related trials for Heat Exposure
Recruiting
Efficacy of Electric Fans in Children During Heat Waves
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Not yet recruiting
Indoor Overheating and Physiological Strain in Older Adults With COPD
Chronic Obstructive Pulmonary Disease (COPD), Heat Stress
Recruiting
Consecutive Occupational Heat Exposure With and Without Overnight Cooling
Body Temperature Changes, Heat Stress
Not yet recruiting
Progressive Heat Exposure and Physiological Strain
Body Temperature Changes, Heat Stress
Recruiting
Assessing the Effectiveness of Heat Adaptation Digital Messages From Primary Care Providers to Their Patients on the Change in Behaviour for Heatwave-related Preparedness
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Ravanelli, PhD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temperature Ramp Protocol in people with Heat Exposure and Healthy, run by Lakehead University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: At baseline (e.g. 0 minutes), and every 10 minutes of exposure up to 180 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.