HypoxiaHYPONCT05044585

Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers

A study testing Remote Automated Monitoring System in people with Hypoxia, run by IHU Strasbourg at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Hypoxia
What is being tested?: Remote Automated Monitoring System
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteFrance
Study dates: 13 Sep 2021to 13 Sep 2022
Phase: Interventional
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 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

France1 site

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

Other trials in France

About this study

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

Read the 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.

Conditions: Hypoxia
Being tested: Remote Automated Monitoring System
Keywords: vital signs, connected device, real-time monitoring, hypoxia, SpO2, non-invasive blood pressure, cardio-respiratory monitoring
Medical subject headings: Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Remote Automated Monitoring SystemOther
The subject will be monitored with conventional monitoring devices as well as the MultiSense patch.

Study groups in NCT05044585
Study group	Role	What they receive
Remote Automated Monitoring System	Experimental	Two MultiSense® patches will be placed on each volunteer. The monitoring will last no more than 3 hours, during an induced and controlled hypoxia. Receives: Other: Remote Automated Monitoring System

What is being measured

The primary outcome is the main question the study is designed to answer.

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%.
Measured: from patch placement to patch removal, assessed up to 3 hours

Secondary outcomes (11)

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)
Measured: from patch placement to patch removal, assessed up to 3 hours
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)
Measured: from patch placement to patch removal, assessed up to 3 hours
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)
Measured: from patch placement to patch removal, assessed up to 3 hours
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)
Measured: from patch placement to patch removal, assessed up to 3 hours
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)
Measured: from patch placement to patch removal, assessed up to 3 hours
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)
Measured: from patch placement to patch removal, assessed up to 3 hours
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.
Measured: 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.
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.
Measured: 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.
Comparison of blood pressure variation measured by a standard cuff device with PTT variation measured by the MultiSense® acquisition system.
Measured: from patch placement to patch removal, assessed up to 3 hours
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.
Measured: 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.
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).
Measured: from patch placement to patch removal, assessed up to 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Sep 202113 Sep 2022

First posted16 Sep 2021
Study start13 Sep 2021
Primary completion13 Sep 2022
Study completion13 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypoxiaStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: prospective feasibility study,
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05044585
Sponsor's protocol ID: 21-001
Acronym: HYPO
Status last verified: Feb 2023
First submitted: 26 Aug 2021
Last updated: 28 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
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All Hypoxia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of RDS MultiSense® in Desaturation Analysis and Effects of Hypoxia on Circulating Oxidative Stress and Mitochondrial Respiration in Healthy Volunteers
ClinicalTrials.gov ID: NCT05044585
Acronym / sponsor ID: HYPO / 21-001
Conditions: Hypoxia
Keywords: vital signs, connected device, real-time monitoring, hypoxia, SpO2, non-invasive blood pressure, cardio-respiratory monitoring
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: IHU StrasbourgUniversity, hospital or other
Collaborators: Rhythm Diagnostic Systems
Study start: 13 Sep 2021 (actual)
Primary completion: 13 Sep 2022 (actual)
Study completion: 13 Sep 2022 (actual)
First posted: 16 Sep 2021 (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.

Detailed description

The study population includes 30 healthy volunteers.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: prospective feasibility study,

Arm	Type	Receives
Remote Automated Monitoring System	Experimental	Other: Remote Automated Monitoring SystemTwo MultiSense® patches will be placed on each volunteer. The monitoring will last no more than 3 hours, during an induced and controlled hypoxia.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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).

Key exclusion criteria (8 listed)

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.

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
Remote Automated Monitoring SystemThe subject will be monitored with conventional monitoring devices as well as the MultiSense patch.	Other	Remote Automated Monitoring System

Primary outcome

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%.

11 secondary outcomes

Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
Time frame: 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
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
Time frame: 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
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions
Time frame: 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 Mitochondrial respiration from PBMCs between hypoxia and normal oxygenation conditions.
Time frame: 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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
Individual participant dataSharing planned: No

Related trials for Hypoxia

Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Enrolling by invitation
Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
Hypoxemia
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia

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.

Bernard Geny, Pr principal investigator

Physiology and Functional Exploration, NHC Strasbourg, France

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Remote Automated Monitoring System in people with Hypoxia, run by IHU Strasbourg at 1 site 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). 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 NCT05044585.

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 28 Feb 2023.