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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.
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:
Secondary objectives:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reference measure | Device | measure of a physiological parameter performed with the gold standard medical device | ||
| alternative measure | Device | measure of a physiological parameter performed with the connected device under evaluation |
| 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 |
| 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 |
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Inclusion criteria :
Exclusion criteria :
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patients referred to the physiology department for at least one examination among : polysomnography, bone densitometry, respiratory functino test, day hospital of cardiology.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Justine FRIJA MASSON, Doctor | Contact | 00 33 1 40 25 84 01 | justine.frija@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Justine FRIJA MASSON, Doctor | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Justine Frija | Recruiting | Paris | 75018 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40911165 | Derived | Frija J, Millet J, Bequignon E, Covali A, Cathelain G, Houenou J, Benzaquen H, Geoffroy PA, Bacry E, Grajoszex M, d'Ortho MP. Proposition of a new, minimally-invasive, software smartphone device to predict sleep apnea and its severity. Sleep Breath. 2025 Sep 5;29(5):282. doi: 10.1007/s11325-025-03441-w. | |
| 33929337 | Derived |
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| Justine Frija | Recruiting | Paris | 75018 | France |
| 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. |