Measuring Core Body Temperature Using a Novel Non-invasive Sensor

Study Overview
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Brief Summary
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The Double Sensor examined in this trial was developed by Dräger Company and is a novel non- invasive device for assessing core body temperature. In a preliminary research investigators have conducted the Double Sensor was found promising for potential use of physiological heat stress early detection. This follow-up experiment was designed to validate the data during high and changing body core temperatures and to examine the Double Sensor performance while integrated into a helmet as in intended application.

Detailed Description
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12 healthy civilian volunteers will arrive to our lab and will undergo 4 experiment days: Recruitment day + VO2max test, 3 random days performing experiment protocol, dressed in uniforms: sitting in thermoneutral condition for one hour, afterwards they will walk on a treadmill in 5.5 km/h and 4% incline in hot chamber (40% celsius and 40% relative humidity) for 1.5 hours. Once connected to rectal thermistor and to the Double Sensor attached to the skin surface by sticker, once same as the day before with addition of cooling system of Icetron Technologies Ltd. worn on the wrist, and once connected to rectal thermistor and to the Double Sensor integrated into a helmet.

Official Title
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Measuring Core Body Temperature Using a Novel Non-invasive Sensor - a Follow up Study

Conditions
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Body Temperature Regulation

Intervention / Treatment
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* Device: Dräger double sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-40 years. Healthy civilian volunteers. Without known medical illness or medication use. Exclusion Criteria: History of heat injury. The existence or suspicion of existing cardiac or respiratory disease. Diabetes. Obesity. Infectious disease 3 days prior to the experiment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: research arm<br>the trial contains one group which will undergo the described protocol three times: connected to rectal thermistor and to the double sensor connected to rectal thermistor, double sensor and cooling system of Icetron Technologies Ltd. connected to rectal thermistor and to the double sensor integrated into a helmet. | Device: Dräger double sensor<br>* The Dräger Double Sensor is a novel non-invasive device for assessing core body temperature.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Double sensor temperature | the Double Sensor will be attached to the forehead by sticker or integrated into a helmet. Double sensor temperature will be monitored continuously. | 3 days for each participant | 
| rectal temperature | rectal thermistor is the gold standard for core body temperature and will be measured continuously. | 3 days for each participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate | heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch). | 4 days for each participant | 
| skin temperature | The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg). | 3 days for each participant |