NCT03803098

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

February 12, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2022

Completed
Last Updated

June 22, 2021

Status Verified

June 1, 2021

Enrollment Period

3 years

First QC Date

October 22, 2018

Last Update Submit

June 21, 2021

Conditions

Respiratory; Disorder, Functional, Impaired

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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 examination

Interventions

reference measureDEVICE

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

alternative measureDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • No defined

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Justine Frija

Paris, 75018, France

RECRUITING

Justine Frija

Paris, 75018, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 40911165DERIVED

  • 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.

    PMID: 33929337DERIVED

Study Officials

  • Justine FRIJA MASSON, Doctor

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Justine FRIJA MASSON, Doctor

CONTACT

00 33 1 40 25 84 01justine.frija@aphp.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2018

First Posted

January 14, 2019

Study Start

February 12, 2019

Primary Completion

February 12, 2022

Study Completion

August 12, 2022

Last Updated

June 22, 2021

Record last verified: 2021-06

Locations

FR(2)