NCT06584903

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

September 3, 2024

Last Update Submit

September 4, 2024

Conditions

Keywords

indoor temperaturecore temperatureheart rateelectric fanscardiovascular strain

Outcome Measures

Primary Outcomes (6)

  • Blood Pressure

    Measured with an electrocardiogram-gated automated cuff

    At baseline (e.g. 0 minutes), and every 10 minutes of exposure up to 180 minutes

  • Rate Pressure Product

    At baseline (e.g. 0 minutes), and every 10 minutes of exposure up to 180 minutes

  • Heart Rate

    Measured with a 3-lead electrocardiogram

    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

    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

    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

    At baseline (e.g. 0 minutes), and every minute for the 180 minute experimental trial

Secondary Outcomes (2)

  • Thermal Sensation

    At baseline (e.g. 0 minutes), and every 10 minutes for the 180 minute experimental trial

  • Thermal comfort

    Assessed at baseline (e.g. 0 minutes), and every 10 minutes for the 180 minute experimental trial

Study Arms (2)

Still air

PLACEBO COMPARATOR

still air condition with no supplemental air flow

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

Other: Temperature Ramp Protocol

Interventions

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.

Electric fanStill air

Eligibility Criteria

Age19 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index less than 30
  • male or female
  • ability to tolerate hot environments for a prolonged period (e.g. \>2 h)

You may not qualify if:

  • Any respiratory disease
  • Any cardiovascular disease, including hypertension
  • Diabetes
  • not currently on any medication (except oral contraceptives)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lakehead University

Thunder Bay, Ontario, P7B 5E1, Canada

Location

Study Officials

  • Nicholas Ravanelli, PhD

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 3, 2024

First Posted

September 5, 2024

Study Start

January 20, 2024

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

All deidentified participant data supporting the findings of this study will be made freely available on the Open Science Framework Repository.

Time Frame
Following publication
Access Criteria
Anyone will be allowed to access the data supporting the findings through the Open Science Framework Repository.

Locations