Evaluation of the Metrological Reliability of Connected Objects in the Measurement of Medical Physiological Parameters (EVALEXPLO)

Evaluation of the Metrological Reliability of Connected Objects Available to the Public in the Measurement of Medical Physiological Parameters

Many connected objects available over-the-counter to the general public claim to measure physical quantities that may have a medical application. Examples include heart rate, oxygen saturation, respiratory rate, blood pressure, body composition between body fat, lean mass and bone mass, and motion analysis. .

The continuous collection of these quantities by a cheap and easily accessible device opens important medical perspectives in the areas of home monitoring of chronic diseases or preventive medicine in general. Nevertheless, the medical decisions that could be made on the basis of the information provided by these objects require that the measurement be reliable, which is not always the case.

The evaluation of the accuracy of measurements made by these objects therefore seems to be a prerequisite for future use in a medical context. This study therefore proposes to test the adequacy between "gold-standard" measurements carried out in consultation in the department of functional explorations of the Bichat Claude-Bernard hospital and the measurements of the same parameters by connected objects, under the conditions of intended uses by their manufacturer.

Study Overview

• Status: Recruiting
• Conditions: Respiratory; Disorder, Functional, Impaired
• Intervention / Treatment: Device: reference measure; Device: alternative measure

Detailed Description

Primary objective : Evaluate, in patients consulting for polysomnography, respiratory functional explorations or osteodensitometry, or as part of a day hospital cardiology. The accuracy of the measurement provided by a connected object in relation to the "gold standard" measurement made during the visit. The parameters studied will be:

• For polysomnography, pulse oxygen saturation (SpO2), heart rate (HR) and respiratory rate (RF), sleep quality (efficacy, duration of mild slow sleep, deep slow sleep and REM sleep)
• For bone densitometry, body composition in lean mass, fat mass and bone mass, weight • For respiratory function tests, pulse oxygen saturation (SpO2) and heart rate (HR)
• For day hospitalization in cardiology, blood pressure (BP), heart rate (HR) and heart rate, existence of rhythm disorders or conduction

Secondary objectives:

• Evaluate the ease of use of the device (evaluated by an ad-hoc questionnaire completed by the nursing staff)
• Describe the temporal evolution of the recorded parameters (excluding osteodensitometry for which the measurement is unique)
• For day hospitalization in cardiology, evaluate the diagnostic performance of objects tested on the existence of cardiac rhythm disorders (sinus bradycardia, sinus tachycardia, atrial fibrillation, presence of extrasystoles) or conduction disorders (atrioventricular block). -ventricular, branch block)

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Justine FRIJA MASSON, Doctor; Phone Number: 00 33 1 40 25 84 01; Email: justine.frija@aphp.fr

Study Locations

• France
  • Paris, France, 75018
    • Recruiting
    • Justine Frija
    • Contact: Justine Frija

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients referred to the physiology department for at least one examination among : polysomnography, bone densitometry, respiratory functino test, day hospital of cardiology.

Description

Inclusion criteria :

• Patient over 18 years old
• Patient sent to the functional exploration department of Bichat hospital to perform one of the following exams: polysomnography, bone densitometry, respiratory function tests, cardiology day hospital assessment
• Patient agreement to participate in the study,
• Affiliated to a social security scheme (benefiting or entitled)

Exclusion criteria :

No defined

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
relative error between the gold-standard measure of the physiological parameter and the corresponding measure with the tested device,	relative error expressed on a percentage	the two measures are succesive of the day of the examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
absolute error between the gold-standard measure of the physiological parameter and the corresponding measure with the tested device,	absolute error expressed on the unit of the reference measurement	the two measures are succesive of the day of the examination

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Justine FRIJA MASSON, Doctor, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Frija-Masson J, Mullaert J, Vidal-Petiot E, Pons-Kerjean N, Flamant M, d'Ortho MP. Accuracy of Smart Scales on Weight and Body Composition: Observational Study. JMIR Mhealth Uhealth. 2021 Apr 30;9(4):e22487. doi: 10.2196/22487.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Anticipated): February 12, 2022
• Study Completion (Anticipated): August 12, 2022

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders
• Other Study ID Numbers: NI18035J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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