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Non-invasive Sensor for Core Temperature Measurement

NCT ID: NCT02017184

Last Updated: 2013-12-20

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Brief Summary

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Soldiers are required to perform and maintain alertness in difficult environmental conditions. The sensor examined in this trail may indicate body core temperature elevation during exertion. 12 male volunteers will arrive to our lab and perform a protocol of sitting and walking in thermoneutral and hot environments with two core temperature sensors. The results obtained from them will be compared.

Detailed Description

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During the protocol the volunteers will sit in thermoneutral condition for 30 minutes, than they will sit in hot chamber (40 celsius and 40% relative humidity). Afterwards, the participants will walk on a treadmill in 5 km/hr and 4% incline for one hour. The participants will be connected to rectal thermistor which is considered the "gold standard" and to the new noninvasive sensor which is attached to the skin surface.

Conditions

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Body Temperature Regulation

Keywords

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Body Temperature Regulation Sensor Noninvasive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Research arm

This trial contains one group which will undergo the described protocol while connected to both sensors: a rectal thermistor and a non invasive thermistor.

Group Type EXPERIMENTAL

Noninvasive core temperature thermistor

Intervention Type BIOLOGICAL

Interventions

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Noninvasive core temperature thermistor

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* age 18-25 - healthy
* after medical checkup
* after signing concent form
* with no heat stroke medical history

Exclusion Criteria

* heat stroke medical history
* heart disease
* diabetes
* obesity
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 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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Yoram Epstein, PhD

Role: STUDY_DIRECTOR

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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Yoram Epstein, PhD

Role: CONTACT

Phone: +972544534384

Email: [email protected]

Facility Contacts

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Yoram Epstein, PhD

Role: primary

Other Identifiers

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IDF-1233-2013

Identifier Type: OTHER

Identifier Source: secondary_id

SHEBA-13-0737-BA-CTIL

Identifier Type: -

Identifier Source: org_study_id