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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01789931
Acronym
lifebeam
Enrollment
10
Registered
2013-02-12
Start date
2014-12-31
Completion date
2016-12-31
Last updated
2014-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heat Illness

Brief summary

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.

Interventions

DEVICELifebeam

The lifebeam sensor will be attached to the participant's skin during the HTT.

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
21 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Heat tolerance test1 yearThe 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.
VO2 test1 yearVolunteer'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.

Secondary

MeasureTime frameDescription
Skin temperature1 yearThe 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.
Rectal temperature1 yearThe 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.
Heart rate1 yearDuring the HTT and the VO2 test heart rates will be monitored continuously and will be stored by a heart rate wristwatch, (POLAR, Finland).
blood circulation parameters1 yearEvaluation by the optic sensor Lifebeam of the blood circulation parameters (heart rate, blood flow velocity, perfusion, and ventilation rate) in the peripheral arterioles

Countries

Israel

Contacts

Primary ContactBarliz Adato, MD
Barliz.Adato@sheba.health.gov.il+972542662201

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026