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

Respiratory; Disorder, Functional, Impaired Clinical Trial

— EVALEXPLO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03803098
• Other study ID #: NI18035J
• Status: Recruiting
• Start date: February 12, 2019
• Est. completion date: August 12, 2022

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Justine FRIJA MASSON, Doctor
• Phone: 00 33 1 40 25 84 01
• Email: justine.frija[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 12, 2022
• Est. primary completion date: February 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory; Disorder, Functional, Impaired

Intervention

Device:
• reference measure
measure of a physiological parameter performed with the gold standard medical device
• alternative measure
measure of a physiological parameter performed with the connected device under evaluation

Locations

Country	Name	City	State
France	Justine Frija	Paris
France	Justine Frija	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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