Back to resultsEvaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers (HYPO)
Primary Purpose
Hypoxia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Remote Automated Monitoring System
Sponsored by
About this trial
This is an interventional other trial for Hypoxia focused on measuring vital signs, connected device, real-time monitoring, hypoxia, SpO2, non-invasive blood pressure, cardio-respiratory monitoring
Eligibility Criteria
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.
Sites / Locations
- Clinical Investigation Center & Physiology and Functional Explorations unit at NHC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Remote Automated Monitoring System
Arm Description
Two MultiSense® patches will be placed on each volunteer. The monitoring will last no more than 3 hours, during an induced and controlled hypoxia.
Outcomes
Primary Outcome Measures
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.
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%.
Secondary Outcome Measures
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
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)
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
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)
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
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)
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
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)
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
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)
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
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)
Comparison of Mitochondrial respiration from PBMCs between hypoxia and normal oxygenation conditions.
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.
To evaluate the impact of skin pigmentation on SpO2 determination by the MultiSense® solution.
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.
To evaluate pulse transit time (PTT) as an indicator of blood pressure (BP) variation.
Comparison of blood pressure variation measured by a standard cuff device with PTT variation measured by the MultiSense® acquisition system.
To evaluate the reliability of the respiration rate determined by the MultiSense® solution
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.
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.
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).
Full Information
NCT ID
NCT05044585
First Posted
August 26, 2021
Last Updated
February 27, 2023
Sponsor
IHU Strasbourg
Collaborators
Rhythm Diagnostic Systems
1. Study Identification
Unique Protocol Identification Number
NCT05044585
Brief Title
Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers
Acronym
HYPO
Official Title
Evaluation of RDS MultiSense® in Desaturation Analysis and Effects of Hypoxia on Circulating Oxidative Stress and Mitochondrial Respiration in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
September 13, 2022 (Actual)
Study Completion Date
September 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IHU Strasbourg
Collaborators
Rhythm Diagnostic Systems
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
Keywords
vital signs, connected device, real-time monitoring, hypoxia, SpO2, non-invasive blood pressure, cardio-respiratory monitoring
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective feasibility study,
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote Automated Monitoring System
Arm Type
Experimental
Arm Description
Two MultiSense® patches will be placed on each volunteer. The monitoring will last no more than 3 hours, during an induced and controlled hypoxia.
Intervention Type
Other
Intervention Name(s)
Remote Automated Monitoring System
Intervention Description
The subject will be monitored with conventional monitoring devices as well as the MultiSense patch.
Primary Outcome Measure Information:
Title
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.
Description
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%.
Time Frame
from patch placement to patch removal, assessed up to 3 hours
Secondary Outcome Measure Information:
Title
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
Description
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)
Time Frame
from patch placement to patch removal, assessed up to 3 hours
Title
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
Description
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)
Time Frame
from patch placement to patch removal, assessed up to 3 hours
Title
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
Description
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)
Time Frame
from patch placement to patch removal, assessed up to 3 hours
Title
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
Description
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)
Time Frame
from patch placement to patch removal, assessed up to 3 hours
Title
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
Description
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)
Time Frame
from patch placement to patch removal, assessed up to 3 hours
Title
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
Description
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)
Time Frame
from patch placement to patch removal, assessed up to 3 hours
Title
Comparison of Mitochondrial respiration from PBMCs between hypoxia and normal oxygenation conditions.
Description
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.
Time Frame
from patch placement to patch removal, assessed up to 3 hours
Title
To evaluate the impact of skin pigmentation on SpO2 determination by the MultiSense® solution.
Description
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.
Time Frame
from patch placement to patch removal, assessed up to 3 hours
Title
To evaluate pulse transit time (PTT) as an indicator of blood pressure (BP) variation.
Description
Comparison of blood pressure variation measured by a standard cuff device with PTT variation measured by the MultiSense® acquisition system.
Time Frame
from patch placement to patch removal, assessed up to 3 hours
Title
To evaluate the reliability of the respiration rate determined by the MultiSense® solution
Description
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.
Time Frame
from patch placement to patch removal, assessed up to 3 hours
Title
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.
Description
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).
Time Frame
from patch placement to patch removal, assessed up to 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Geny, Pr
Organizational Affiliation
Physiology and Functional Exploration, NHC Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Investigation Center & Physiology and Functional Explorations unit at NHC
City
Strasbourg
ZIP/Postal Code
67000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers
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