Follow Fever to Decide
Primary Purpose
Body Temperature Changes
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
F2D armband
Sponsored by
About this trial
This is an interventional other trial for Body Temperature Changes focused on measuring Body Temperature, Circadian Rhythm
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.
Sites / Locations
- Laboratoire COMETE UMR-S 1075
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Observational
Arm Description
Comparison of the core temperature obtained during 24-48 h with eCelsius and with F2D armband in different life situations.
Outcomes
Primary Outcome Measures
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.
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.
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 .
Secondary Outcome Measures
Full Information
NCT ID
NCT04311268
First Posted
March 12, 2020
Last Updated
April 6, 2022
Sponsor
Slb Pharma
Collaborators
Université de Caen Normandie, Capital Innovation
1. Study Identification
Unique Protocol Identification Number
NCT04311268
Brief Title
Follow Fever to Decide
Official Title
Follow Fever to Decide: Determination of an Algorithm to Quantify and Qualify the Circadian Rhythmicity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 13, 2020 (Actual)
Primary Completion Date
December 18, 2021 (Actual)
Study Completion Date
December 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Slb Pharma
Collaborators
Université de Caen Normandie, Capital Innovation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Temperature Changes
Keywords
Body Temperature, Circadian Rhythm
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
306 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observational
Arm Type
Experimental
Arm Description
Comparison of the core temperature obtained during 24-48 h with eCelsius and with F2D armband in different life situations.
Intervention Type
Device
Intervention Name(s)
F2D armband
Intervention Description
Comparison of the core temperature obtained during 24-48 h with eCelsius and with F2D armband in different life situations.
Primary Outcome Measure Information:
Title
WP1 (body temperature)
Description
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.
Time Frame
24 hours
Title
WP2 (body temperature)
Description
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.
Time Frame
48 hours
Title
WP3 (body temperature)
Description
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 .
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Laboratoire COMETE UMR-S 1075
City
Caen
ZIP/Postal Code
14000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22488144
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.
Results Reference
background
PubMed Identifier
26974732
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.
Results Reference
background
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