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Measuring Core Body Temperature Using a Novel Non-invasive Sensor

Measuring Core Body Temperature Using a Novel Non-invasive Sensor - a Follow up Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02691832
Acronym
Dräger
Enrollment
12
Registered
2016-02-25
Start date
2016-05-31
Completion date
2017-08-31
Last updated
2016-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Temperature Regulation

Brief summary

The Double Sensor examined in this trial was developed by Dräger Company and is a novel non- invasive device for assessing core body temperature. In a preliminary research investigators have conducted the Double Sensor was found promising for potential use of physiological heat stress early detection. This follow-up experiment was designed to validate the data during high and changing body core temperatures and to examine the Double Sensor performance while integrated into a helmet as in intended application.

Detailed description

12 healthy civilian volunteers will arrive to our lab and will undergo 4 experiment days: Recruitment day + VO2max test, 3 random days performing experiment protocol, dressed in uniforms: sitting in thermoneutral condition for one hour, afterwards they will walk on a treadmill in 5.5 km/h and 4% incline in hot chamber (40% celsius and 40% relative humidity) for 1.5 hours. Once connected to rectal thermistor and to the Double Sensor attached to the skin surface by sticker, once same as the day before with addition of cooling system of Icetron Technologies Ltd. worn on the wrist, and once connected to rectal thermistor and to the Double Sensor integrated into a helmet.

Interventions

DEVICEDräger double sensor

The Dräger Double Sensor is a novel non-invasive device for assessing core body temperature.

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged 18-40 years. * Healthy civilian volunteers. * Without known medical illness or medication use.

Exclusion criteria

* History of heat injury. * The existence or suspicion of existing cardiac or respiratory disease. * Diabetes. * Obesity. * Infectious disease 3 days prior to the experiment.

Design outcomes

Primary

MeasureTime frameDescription
Double sensor temperature3 days for each participantthe Double Sensor will be attached to the forehead by sticker or integrated into a helmet. Double sensor temperature will be monitored continuously.
rectal temperature3 days for each participantrectal thermistor is the gold standard for core body temperature and will be measured continuously.

Secondary

MeasureTime frameDescription
heart rate4 days for each participantheart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
skin temperature3 days for each participantThe skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).

Countries

Israel

Contacts

Primary ContactHaggai Schermann, M.D
Haggai.Schermann@sheba.health.gov.il+972828771014

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026