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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03803098
Acronym
EVALEXPLO
Enrollment
400
Registered
2019-01-14
Start date
2019-02-12
Completion date
2022-08-12
Last updated
2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory; Disorder, Functional, Impaired

Brief 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.

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)

Interventions

DEVICEreference measure

measure of a physiological parameter performed with the gold standard medical device

DEVICEalternative measure

measure of a physiological parameter performed with the connected device under evaluation

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
relative error between the gold-standard measure of the physiological parameter and the corresponding measure with the tested device,the two measures are succesive of the day of the examinationrelative error expressed on a percentage

Secondary

MeasureTime frameDescription
absolute error between the gold-standard measure of the physiological parameter and the corresponding measure with the tested device,the two measures are succesive of the day of the examinationabsolute error expressed on the unit of the reference measurement

Countries

France

Contacts

Primary ContactJustine FRIJA MASSON, Doctor
justine.frija@aphp.fr00 33 1 40 25 84 01

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026