NCT04311268

Follow Fever to Decide

Follow Fever to Decide: Determination of an Algorithm to Quantify and Qualify the Circadian Rhythmicity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Slb Pharma · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Body temperature is one of the markers of biological rhythms. The precise determination of the functioning of the biological clock for an individual is essential to understanding his physiological state at a given time. This condition is dependent on the "timing" of its central clock on the time scale (chronotype). The provision of a simple-to-use (F2D cuff), non-invasive and time-dependable temperature tool and the creation of appropriate algorithms would allow access to the operation of the central clock and open up many therapeutic applications.

Detailed description

While the measurement of body temperature is one of the first self-diagnosis gestures at home, it is unanimously agreed by healthcare professionals that the measurement of non-invasive body temperature performed both in a hospital setting, in the office, that at home is very imprecise, or even false. As a result, temperature is only an indicator and is of little interest. Only the rectal thermometer and the telemetric capsule (e-CELSIUS® capsule to be ingested that allows a reliable and continuous measurement of gastrointestinal temperature without the intervention of the caregiver) are reliable tools, but they remain invasive and do not always allow for fully reliable follow-up over time. We propose to develop an algorithm integrated in an external, non-invasive cuff, allowing the continuous recording of body temperature. In addition, body temperature is one of the markers of biological rhythms. The precise determination of the functioning of the biological clock for an individual is essential to understanding his physiological state at a given time. This condition is dependent on the "timing" of its central clock on the time scale (chronotype). The provision of a simple-to-use (F2D cuff), non-invasive and time-dependable temperature tool and the creation of appropriate algorithms would allow access to the operation of the central clock and open up many therapeutic applications. This work proposes to validate the tool on the one hand and on the other to use this tool to produce the elements necessary for monitoring the functioning of the central biological clock.

Conditions

• Body Temperature Changes

Interventions

Type	Name	Description
DEVICE	F2D armband	Comparison of the core temperature obtained during 24-48 h with eCelsius and with F2D armband in different life situations.

Timeline

• Start date: 2020-03-13
• Primary completion: 2021-12-18
• Completion: 2021-12-18
• First posted: 2020-03-17
• Last updated: 2022-04-07

Locations

1 site across 1 country: France