NCT04311268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

March 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2021

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

March 12, 2020

Last Update Submit

April 6, 2022

Conditions

Body Temperature Changes

Keywords

Body TemperatureCircadian Rhythm

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Observational

EXPERIMENTAL

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

Device: F2D armband

Interventions

F2D armbandDEVICE

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

Observational

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire COMETE UMR-S 1075

Caen, 14000, France

Location

Related Publications (2)

  • 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.

    PMID: 22488144BACKGROUND

  • 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.

    PMID: 26974732BACKGROUND

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 17, 2020

Study Start

March 13, 2020

Primary Completion

December 18, 2021

Study Completion

December 18, 2021

Last Updated

April 7, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)