Respiratory; Disorder, Functional, ImpairedEVALEXPLONCT03803098
Evaluation of the Metrological Reliability of Connected Objects in the Measurement of Medical Physiological Parameters
An observational study of Respiratory; Disorder, Functional, Impaired, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory; Disorder, Functional, Impaired
- What is being tested?
- reference measure and alternative measure
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Feb 2019to 12 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients referred to the physiology department for at least one examination among : polysomnography, bone densitometry, respiratory functino test, day hospital of cardiology.
Who may be able to join
- 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)
Who cannot join
- No defined
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Justine Frija
Paris, 75018
Justine Frija
- Recruiting
Justine Frija
Paris, 75018
About this study
Official title: Evaluation of the Metrological Reliability of Connected Objects Available to the Public in the Measurement of Medical Physiological Parameters
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.
Read the 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)
- Being tested
- reference measure, alternative measure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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,
absolute error expressed on the unit of the reference measurement
Measured: the two measures are succesive of the day of the examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start12 Feb 2019
- Primary completion12 Feb 2022 (estimated)
- Study completion12 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory; Disorder, Functional, ImpairedStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justine FRIJA MASSON, Doctor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803098
- Sponsor's protocol ID
- NI18035J
- Acronym
- EVALEXPLO
- Status last verified
- Jun 2021
- First submitted
- 22 Oct 2018
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40911165Frija-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.
PubMed 33929337
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Metrological Reliability of Connected Objects Available to the Public in the Measurement of Medical Physiological Parameters
- ClinicalTrials.gov ID
- NCT03803098
- Acronym / sponsor ID
- EVALEXPLO / NI18035J
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 12 Feb 2022 (estimated)
- Study completion
- 12 Aug 2022 (estimated)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients referred to the physiology department for at least one examination among : polysomnography, bone densitometry, respiratory functino test, day hospital of cardiology.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- No defined
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reference measuremeasure of a physiological parameter performed with the gold standard medical device | Device | – |
| alternative measuremeasure of a physiological parameter performed with the connected device under evaluation | Device | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Derived from this study: PubMed 40911165Frija 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.
- Derived from this study: PubMed 33929337Frija-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justine FRIJA MASSON, Doctor principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory; Disorder, Functional, Impaired, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justine FRIJA MASSON, Doctor (00 33 1 40 25 84 01, justine.frija@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03803098, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.