Non-invasive Sensor for Core Temperature Measurement

Not Applicable

• Conditions: Body Temperature Regulation
• Interventions: Biological: Noninvasive core temperature thermistor

• Registration Number: NCT02017184
• Lead Sponsor: Sheba Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2013-12
• Study Start: 2013-12
• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-19
• Last Update Submitted: 2013-12-19
• Study First Posted: 2013-12-20
• Last Update Posted: 2013-12-20
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

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

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Exclusion Criteria

• heat stroke medical history
• heart disease
• diabetes
• obesity

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Research arm	Noninvasive core temperature thermistor	This trial contains one group which will undergo the described protocol while connected to both sensors: a rectal thermistor and a non invasive thermistor.

Primary Outcome Measures

Name	Time	Method
Rectal temperature	1 year	The participants will undergo the described protocol and their rectal temperature will be measured by rectal thermistor and the new noninvasive thermistor and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system.

Trial Locations

Locations (1)

Sheba medical center; 🇮🇱 Tel-Hashomer, Ramat- Gan, Israel