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

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ClinicalTrials.gov Identifier: NCT03803098
Recruitment Status : Not yet recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment
Respiratory; Disorder, Functional, Impaired 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)

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Metrological Reliability of Connected Objects Available to the Public in the Measurement of Medical Physiological Parameters
Estimated Study Start Date : January 10, 2019
Estimated Primary Completion Date : January 10, 2020
Estimated Study Completion Date : December 31, 2020

Intervention Details:
  • 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


Primary Outcome Measures :
  1. relative error between the gold-standard measure of the physiological parameter and the corresponding measure with the tested device, [ Time Frame: the two measures are succesive of the day of the examination ]
    relative error expressed on a percentage


Secondary Outcome Measures :
  1. absolute error between the gold-standard measure of the physiological parameter and the corresponding measure with the tested device, [ Time Frame: the two measures are succesive of the day of the examination ]
    absolute error expressed on the unit of the reference measurement



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803098


Contacts
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Contact: Justine FRIJA MASSON, Doctor 00 33 1 40 25 84 01 justine.frija@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Justine FRIJA MASSON, Doctor Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03803098    
Other Study ID Numbers: NI18035J
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases