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

NCT ID: NCT01789931

Last Updated: 2014-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-12-31

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.

Detailed Description

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Conditions

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Heat Illness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

"Lifebeam"

Intervention Type DEVICE

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

Interventions

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"Lifebeam"

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

Intervention Type DEVICE

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Barliz Adato

head investigator of Heller institute of physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barliz Adato, MD

Role: PRINCIPAL_INVESTIGATOR

Heller institute, Sheba medical center

Locations

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Sheba medical center

Tel-Hashomer, Ramat- Gan, , Israel

Site Status

Countries

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Israel

Central Contacts

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Barliz Adato, MD

Role: CONTACT

+972542662201

Facility Contacts

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Barliz Adato, MD

Role: primary

Other Identifiers

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SHEBA-12-9435-BA-CTIL

Identifier Type: -

Identifier Source: org_study_id

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