NCT05044585

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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

August 26, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

September 13, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2022

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

August 26, 2021

Last Update Submit

February 27, 2023

Conditions

Hypoxia

Keywords

vital signsconnected devicereal-time monitoringhypoxiaSpO2non-invasive blood pressurecardio-respiratory monitoring

Outcome Measures

Primary Outcomes (1)

  • 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%.

    from patch placement to patch removal, assessed up to 3 hours

Secondary Outcomes (11)

  • Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions

    from patch placement to patch removal, assessed up to 3 hours

  • Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions

    from patch placement to patch removal, assessed up to 3 hours

  • Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions

    from patch placement to patch removal, assessed up to 3 hours

  • Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions

    from patch placement to patch removal, assessed up to 3 hours

  • Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions

    from patch placement to patch removal, assessed up to 3 hours

  • +6 more secondary outcomes

Study Arms (1)

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.

Other: Remote Automated Monitoring System

Interventions

Remote Automated Monitoring SystemOTHER

The subject will be monitored with conventional monitoring devices as well as the MultiSense patch.

Remote Automated Monitoring System

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 under guardianship or trusteeship.
  • Subject under the protection of justice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Investigation Center & Physiology and Functional Explorations unit at NHC

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bernard Geny, Pr

    Physiology and Functional Exploration, NHC Strasbourg, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: prospective feasibility study,
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2021

First Posted

September 16, 2021

Study Start

September 13, 2021

Primary Completion

September 13, 2022

Study Completion

September 13, 2022

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)