Examination of a New Non Invasive Sensor Lifebeam During HTT in Protective Clothing

Study Overview
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Brief Summary
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CB (Chemical Biological)protective clothing provides a thermal resistance between the human body and its environment. CB protective clothing will be essential for combat soldiers in case of non conventional attacks. Lifebeam developed a new non invasive sensor for body core temperature detection. The research purpose is to evaluate the Lifebeam sensor during heat tolerance test while wearing CB protective clothing.

Official Title
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Examination of a New Non Invasive Sensor Lifebeam During HTT (Heat Tolerance Test) in Protective Clothing

Conditions
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Heat Illness

Intervention / Treatment
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* Device: Lifebeam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 21-30 healthy after medical checkup after signing concent form Exclusion Criteria: heart disease respiratory disease baseline bp above 140/90 mmHg sleep disorders diabetes anhydrosis skin disease acute illness in last 3 days prior to the examination

Ages Eligible for Study
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Minimum Age: 21 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Research arm<br>The participants will undergo an examination day in which they will complete VO2max test to evaluate their aerobic fitness. Afterwards they'll undergo 3 heat tolerance test (HTT) days: without CB protective clothing, with CB protective clothing, and with work clothes. During the tests, a Lifebeam sensor will be attached to their skin. | Device: Lifebeam<br>* The lifebeam sensor will be attached to the participant's skin during the HTT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heat tolerance test | The test is performed in a climatic chamber at a temperature of 40oC and 40% relative humidity. During the test, the subject walks on a treadmill at a speed of 5 km/hr at a 2% grade for 2h. Body core temperature and heart rate are continuously monitored, and sweat rate is computed from body weight prior to and after the test, corrected for fluid intake. Heat intolerance is determined when body core temperature elevates above 38.5oC, when heart rate elevates above 150 bpm, or when either does not tend to reach a plateau. | 1 year | 
| VO2 test | Volunteer's oxygen consumption (VO2) will be monitored continuously with a metabolic chart (ZAN), while running for 10 min on a treadmill under comfortable environmental conditions. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin temperature | The volunteers will undergo heat tolerance test. Their skin temperature will be measured by skin thermistors and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system. | 1 year | 
| Rectal temperature | The volunteers will undergo heat tolerance test. Their rectal temperature will be measured by rectal thermistor and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system. | 1 year | 
| Heart rate | During the HTT and the VO2 test heart rates will be monitored continuously and will be stored by a heart rate wristwatch, (POLAR, Finland). | 1 year | 
| blood circulation parameters | Evaluation by the optic sensor Lifebeam of the blood circulation parameters (heart rate, blood flow velocity, perfusion, and ventilation rate) in the peripheral arterioles | 1 year |