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

NCT03803098 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2021-06-22

No results posted yet for this study

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.

Conditions

  • Respiratory; Disorder, Functional, Impaired

Interventions

DEVICE

reference measure

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

DEVICE

alternative measure

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Justine FRIJA MASSON, Doctor · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2022-02-12
Completion
2022-08-12

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03803098 on ClinicalTrials.gov