We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Examination of a New Non Invasive Sensor "Lifebeam" During HTT in Protective Clothing (lifebeam)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01789931
Recruitment Status : Unknown
Verified May 2014 by Dr. Barliz Adato, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 12, 2013
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Heat Illness Device: "Lifebeam"

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Examination of a New Non Invasive Sensor "Lifebeam" During HTT (Heat Tolerance Test) in Protective Clothing
Study Start Date : December 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016
Arms and Interventions

Arm Intervention/treatment
Experimental: Research arm
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"
The "lifebeam" sensor will be attached to the participant's skin during the HTT.


Outcome Measures

Primary Outcome Measures :
  1. Heat tolerance test [ Time Frame: 1 year ]
    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.

  2. VO2 test [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Skin temperature [ Time Frame: 1 year ]
    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.

  2. Rectal temperature [ Time Frame: 1 year ]
    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.

  3. Heart rate [ Time Frame: 1 year ]
    During the HTT and the VO2 test heart rates will be monitored continuously and will be stored by a heart rate wristwatch, (POLAR, Finland).

  4. blood circulation parameters [ Time Frame: 1 year ]
    Evaluation by the optic sensor "Lifebeam" of the blood circulation parameters (heart rate, blood flow velocity, perfusion, and ventilation rate) in the peripheral arterioles


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789931


Contacts
Contact: Barliz Adato, MD +972542662201 Barliz.Adato@sheba.health.gov.il

Locations
Israel
Sheba medical center Not yet recruiting
Tel-Hashomer, Ramat- Gan, Israel
Contact: Barliz Adato, MD       Barliz.Adato@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Barliz Adato, MD Heller institute, Sheba medical center
More Information

Responsible Party: Dr. Barliz Adato, head investigator of Heller institute of physiology, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01789931     History of Changes
Other Study ID Numbers: SHEBA-12-9435-BA-CTIL
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: May 8, 2014
Last Verified: May 2014