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Completed

NCT Number: NCT04311268

Follow Fever to Decide

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratoire COMETE UMR-S 1075

Caen, 14000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

F2D armband

Device

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

Primary outcomes

  1. WP1 (body temperature)

    Time frame: 24 hours

    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.

  2. WP2 (body temperature)

    Time frame: 48 hours

    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.

  3. WP3 (body temperature)

    Time frame: 48 hours

    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 .

Sponsors and collaborators

Lead sponsor

Slb Pharma

Other

Collaborators

  • Capital Innovation
  • Université de Caen Normandie

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2020
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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