Follow Fever to Decide

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

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.

Study Overview

• Status: Completed
• Conditions: Body Temperature Changes
• Intervention / Treatment: Device: F2D armband

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.

• Study Type: Interventional
• Enrollment (Actual): 306
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Laboratoire COMETE UMR-S 1075

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Observational; Comparison of the core temperature obtained during 24-48 h with eCelsius and with F2D armband in different life situations.	Device: F2D armband; Comparison of the core temperature obtained during 24-48 h with eCelsius and with F2D armband in different life situations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WP1 (body temperature)	Comparison of the body temperature obtained by the e-CELSIUS® system with the body temperature obtained with the F2D system in 2 situations : during an exercice, to rise the core temperature, and during a nap taken in the afternoon to reduce it.	24 hours
WP2 (body temperature)	To continuously record the internal and external body temperature obtained with the e-CELSIUS® system and the F2D cuff for 48 hours to obtain a corpus of data allowing algorithm productions being able to quantify and qualify the circadian rhythmicity and determine the chronotype of normo-weighted subjects.	48 hours
WP3 (body temperature)	To continuously record the internal and external body temperature obtained with the e-CELSIUS® system and the F2D cuff for 48 hours to obtain a corpus of data allowing algorithm productions being able to quantify and qualify the circadian rhythmicity and determine the chronotype of subjects with varying ages and body sizes .	48 hours

Collaborators and Investigators

• Sponsor: Slb Pharma
• Collaborators: Université de Caen Normandie; Capital Innovation

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): December 18, 2021
• Study Completion (Actual): December 18, 2021

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Circadian Rhythm; Body Temperature
• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: F2D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No