Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers (HYPO)

February 27, 2023 updated by: IHU Strasbourg

Evaluation of RDS MultiSense® in Desaturation Analysis and Effects of Hypoxia on Circulating Oxidative Stress and Mitochondrial Respiration in Healthy Volunteers

In this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless MultiSense® monitoring patch in 30 healthy volunteers under induced and controlled hypoxia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The MultiSense® strip is a unique, band aid-sized, clinical signal quality, connected strip for real-time monitoring of cardio-respiratory parameters. The MultiSense® strip measures in real-time, remotely and continuously 11 clinical key-indicators by being attached to the patient thorax: ECG trace, heart rate, oxygen saturation, respiratory rate and relative respiration depth, pulse transit time, plethysmographic trace, perfusion index, skin temperature, physical activity and body position. Designed to be worn continuously for at least seven days, the patient can keep the patch during his sleep or in the shower.

The aim of this study is to determine the quality of measurements of arterial blood saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with a reference Pulse Oximetry System under induced hypoxia, in terms of accuracy.

The study population includes 30 healthy volunteers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Strasbourg, France, 67000
        • Clinical Investigation Center & Physiology and Functional Explorations unit at NHC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women between 18 to 50 years of age.
  • Subject able to receive and understand information related to the study and give written informed consent.
  • Subject is a non-smoker or an ex-smoker (stopped smoking for at least 6 months).
  • Subject demographics include a range of dark skin pigmentations, including at least 30% of the total pool, assessed by phototypes V and VI according to the Fitzpatrick scale (Questionnaire score between 28 and 40).
  • Subject is healthy (assessed by a physical examination AND normal ECG AND absence of medical treatment except for the birth control pill).
  • Subject authorizing the treatment of their personal data collected during the study (box checked in the consent form).
  • Subject affiliated to the French social security system.

Exclusion Criteria:

  • Subject with antecedent of allergies to adhesives or silicone or a skin disease that would preclude the use of an adhesive.
  • Subject with an implantable device such as a pacemaker.
  • Pregnant or lactating women (assessed by a negative ß-HCG test).
  • Subject with a high-altitude stay during the previous 4 weeks (more than 1 week spent over 3,500 meters).
  • Subject with Raynaud's syndrome.
  • Subject in exclusion period (determined by a previous or a current study).
  • Subject under guardianship or trusteeship.
  • Subject under the protection of justice.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Remote Automated Monitoring System
Two MultiSense® patches will be placed on each volunteer. The monitoring will last no more than 3 hours, during an induced and controlled hypoxia.
Other: Remote Automated Monitoring System
The subject will be monitored with conventional monitoring devices as well as the MultiSense patch.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determination of the quality of measurements of arterial blood saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with a reference Pulse Oximetry System, in terms of accuracy.
Time Frame: from patch placement to patch removal, assessed up to 3 hours
Accuracy is defined as an average measurement variation less than 3.5% of the mean value to the reference standard. The data for analysis will be equally distributed across the SpO2 range of 70-100%.
from patch placement to patch removal, assessed up to 3 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
Time Frame: from patch placement to patch removal, assessed up to 3 hours
comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of anion superoxide (µmol/min)
from patch placement to patch removal, assessed up to 3 hours
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
Time Frame: from patch placement to patch removal, assessed up to 3 hours
comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of lipids peroxidation (µg/mL)
from patch placement to patch removal, assessed up to 3 hours
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
Time Frame: from patch placement to patch removal, assessed up to 3 hours
comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of protein carbonylation (ng/mL)
from patch placement to patch removal, assessed up to 3 hours
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
Time Frame: from patch placement to patch removal, assessed up to 3 hours
comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of catalase (U/mg protein)
from patch placement to patch removal, assessed up to 3 hours
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
Time Frame: from patch placement to patch removal, assessed up to 3 hours
comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of superoxide dismutase (U/mg protein)
from patch placement to patch removal, assessed up to 3 hours
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
Time Frame: from patch placement to patch removal, assessed up to 3 hours
comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of glutathione (µmol/g protein)
from patch placement to patch removal, assessed up to 3 hours
Comparison of Mitochondrial respiration from PBMCs between hypoxia and normal oxygenation conditions.
Time Frame: from patch placement to patch removal, assessed up to 3 hours
Mitochondrial respiration from PBMCs is assessed by high-resolution respirometry by analysis of the kinetic of the respirometry results and comparison between each hypoxia /post-hypoxia data point with the baseline.
from patch placement to patch removal, assessed up to 3 hours
To evaluate the impact of skin pigmentation on SpO2 determination by the MultiSense® solution.
Time Frame: from patch placement to patch removal, assessed up to 3 hours
Comparison of the MultiSense® SpO2 performances with the reference between light and dark-pigmented subjects. Qualitative comparison of the raw PPG signal between light and dark-pigmented skin subjects.
from patch placement to patch removal, assessed up to 3 hours
To evaluate pulse transit time (PTT) as an indicator of blood pressure (BP) variation.
Time Frame: from patch placement to patch removal, assessed up to 3 hours
Comparison of blood pressure variation measured by a standard cuff device with PTT variation measured by the MultiSense® acquisition system.
from patch placement to patch removal, assessed up to 3 hours
To evaluate the reliability of the respiration rate determined by the MultiSense® solution
Time Frame: from patch placement to patch removal, assessed up to 3 hours
Determination of the quality of respiration rate provided by the MultiSense® patch in comparison to measurements made with reference medical devices in the hospital setting, in terms of accuracy. Accuracy is defined as an average measurement variation less than 5% of the respiration rate mean value to the reference standard.
from patch placement to patch removal, assessed up to 3 hours
To compare the quality of MultiSense® data from a patch worn on the chest and from a patch worn on the upper back in different body posture and to evaluate the impact of strip exact localization on the chest.
Time Frame: from patch placement to patch removal, assessed up to 3 hours
Qualitative comparison of the raw PPG signal between the two patches location for each subject (chest and back). Comparison of the SpO2 derived by each MultiSense® patch to the reference during the resting period in different lying positions (supine, prone, left and right side).
from patch placement to patch removal, assessed up to 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IHU Strasbourg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rhythm Diagnostic Systems

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bernard Geny, Pr, Physiology and Functional Exploration, NHC Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 13, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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