NCT04964609

Brief Summary

The aim of this study is to test the accuracy of EmbracePlus computed SpO2 during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the the subject device during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 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

Study Start

First participant enrolled

June 16, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2022

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

1.4 years

First QC Date

July 6, 2021

Last Update Submit

November 21, 2022

Conditions

Oximetry

Keywords

OximetryWearableSpO2

Outcome Measures

Primary Outcomes (1)

  • SpO2 Accuracy

    SpO2 as measured by the subject device during periods of low motion will be compared to the oxyhemoglobin saturation (SaO2) as measured by direct oximetry with a Radiometer ABL-90 multi-wavelength oximeter

    Through study completion, 3 months average

Study Arms (1)

Single Arm

EXPERIMENTAL

Comparison of EmbracePlus SpO2 readings with arterial blood saturation laboratory analysis in the same subject

Device: EmbracePlus

Interventions

EmbracePlusDEVICE

A device intended for use by researchers and healthcare professionals for continuous collection of physiological parameters in home and healthcare settings. Parallel blood gas analysis to determine oxyhemoglobin saturation (SaO2) using an ABL-90 multi-wavelength oximeter.

Single Arm

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The subject is male or female, aged ≥18 and \<50.
  • The subject is in good general health with no evidence of any medical problems.
  • The subject is fluent in both written and spoken English.
  • The subject has provided informed consent and is willing to comply with the study procedures.

You may not qualify if:

  • The subject is obese (BMI\>30).
  • The subject has a known history of heart disease, lung disease, kidney or liver disease.
  • Diagnosis of asthma, sleep apnea, or use of CPAP.
  • Subject has diabetes.
  • Subject has a clotting disorder.
  • The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
  • The subject has any other serious systemic illness.
  • The subject is a current smoker.
  • Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
  • The subject has a history of fainting or vasovagal response.
  • The subject has a history of sensitivity to local anesthesia.
  • The subject has a diagnosis of Raynaud's disease.
  • The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
  • The subject is pregnant, lactating or trying to get pregnant.
  • The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • Gerboni G, Comunale G, Chen W, Lever Taylor J, Migliorini M, Picard R, Cruz M, Regalia G. Prospective clinical validation of the Empatica EmbracePlus wristband as a reflective pulse oximeter. Front Digit Health. 2023 Dec 4;5:1258915. doi: 10.3389/fdgth.2023.1258915. eCollection 2023.

    PMID: 38111608DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 16, 2021

Study Start

June 16, 2021

Primary Completion

November 21, 2022

Study Completion

November 21, 2022

Last Updated

November 25, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)