NCT02017184

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

December 20, 2013

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

December 16, 2013

Last Update Submit

December 19, 2013

Conditions

Body Temperature Regulation

Keywords

Body Temperature Regulation Sensor Noninvasive

Outcome Measures

Primary Outcomes (1)

  • Rectal temperature

    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.

    1 year

Study Arms (1)

Research arm

EXPERIMENTAL

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

Biological: Noninvasive core temperature thermistor

Interventions

Noninvasive core temperature thermistorBIOLOGICAL
Research arm

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center

Tel-Hashomer, Ramat- Gan, Israel

Location

Study Officials

  • Yoram Epstein, PhD

    Heller institute, Sheba medical center

    STUDY DIRECTOR

Central Study Contacts

Yoram Epstein, PhD

CONTACT

+972544534384Yoram.Epstein@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
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 16, 2013

First Posted

December 20, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2014

Last Updated

December 20, 2013

Record last verified: 2013-12

Locations

IL(1)