Examination of a New Non Invasive Sensor "Lifebeam" During HTT in Protective Clothing
lifebeam
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2012
CompletedFirst Posted
Study publicly available on registry
February 12, 2013
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 8, 2014
May 1, 2014
1 year
December 6, 2012
May 7, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Skin temperature
1 year
Rectal temperature
1 year
Heart rate
1 year
blood circulation parameters
1 year
Study Arms (1)
Research arm
EXPERIMENTALThe 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.
Interventions
The "lifebeam" sensor will be attached to the participant's skin during the HTT.
Eligibility Criteria
You may qualify if:
- age 21-30
- healthy
- after medical checkup
- after signing concent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba medical center
Tel-Hashomer, Ramat- Gan, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barliz Adato, MD
Heller institute, Sheba medical center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- head investigator of Heller institute of physiology
Study Record Dates
First Submitted
December 6, 2012
First Posted
February 12, 2013
Study Start
December 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2016
Last Updated
May 8, 2014
Record last verified: 2014-05