Clinical trial NCT04311268: Follow Fever to Decide
Official title: Follow Fever to Decide: Determination of an Algorithm to Quantify and Qualify the Circadian Rhythmicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Temperature Changes
Keywords: Body Temperature
Circadian Rhythm
Lead sponsor: Slb Pharma
Sponsor class: OTHER
Collaborators: name: Université de Caen Normandie
name: Capital Innovation
First posted: 2020-03-17
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female,
* Between 18 and 40 years of age for the WP I and II phases, and between 18 and 80 years of age for the WP III phase,
* Having an BMI within the range \[18.5; 24.9\] kg/m² for the Work Package I and II phases, and between \[18.5; 34.9\] kg/m² for the Work Package III phase,
* Beneficiary of the social security,
* Provided informed consent for participation in the study.

Exclusion Criteria:

* Presenting an acute pathology,
* Chronic pathology not followed and balanced,
* Having intestinal disorders (diverticles, disorders of the motility of the digestive tract, ...) or having undergone surgery at the gastrointestinal level,
* With known swallowing disorders,
* Having an alcohol dependence (more than 28 alcohol units per week), benzodiazepines or any illicit product,
* Smoking more than 5 cigarettes per day,
* Working nights or shift work,
* Simultaneous participation in other clinical research or participation in another clinical study for which the exclusion period has not ended.

Primary outcomes:
measure: WP1 (body temperature)
timeFrame: 24 hours
measure: WP2 (body temperature)
timeFrame: 48 hours
measure: WP3 (body temperature)
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Laboratoire COMETE UMR-S 1075
Study officials:
References:
citation: Mazerolle SM, Ganio MS, Casa DJ, Vingren J, Klau J. Is oral temperature an accurate measurement of deep body temperature? A systematic review. J Athl Train. 2011 Sep-Oct;46(5):566-73. doi: 10.4085/1062-6050-46.5.566.
citation: Weed HG. Review: Peripheral thermometers do not have clinically acceptable accuracy for measuring core body temperature. Ann Intern Med. 2016 Mar 15;164(6):JC32. doi: 10.7326/ACPJC-2016-164-6-032. No abstract available.