OximetryNCT04964609
EmbracePlus SpO2 Accuracy Validation
A study testing EmbracePlus in people with Oximetry, run by Empatica, Inc. at 1 site in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Oximetry
- What is being tested?
- EmbracePlus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2021to 21 Nov 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California
San Francisco, California, 94143
About this study
Official title: Accuracy of Pulse Oximeters With Profound Hypoxia
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.
- Conditions
- Oximetry
- Being tested
- EmbracePlus
- Keywords
- Oximetry, Wearable, SpO2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Comparison of EmbracePlus SpO2 readings with arterial blood saturation laboratory analysis in the same subject Receives: Device: EmbracePlus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, 3 months average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start16 Jun 2021
- Primary completion21 Nov 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OximetryStudies 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
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Empatica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Empatica Srl
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964609
- Sponsor's protocol ID
- CIP-4
- Other IDs
- EMPA01
- Status last verified
- Nov 2022
- First submitted
- 6 Jul 2021
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38111608
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Pulse Oximeters With Profound Hypoxia
- ClinicalTrials.gov ID
- NCT04964609
- Acronym / sponsor ID
- CIP-4
- Conditions
- Oximetry
- Keywords
- Oximetry, Wearable, SpO2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Empatica, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Empatica Srl
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 16 Jul 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: EmbracePlusComparison of EmbracePlus SpO2 readings with arterial blood saturation laboratory analysis in the same subject |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| EmbracePlusA 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. | Device | Single Arm |
Primary outcome
SpO2 Accuracy
Time frame: Through study completion, 3 months average
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
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 25 Nov 2022.
- Derived from this study: PubMed 38111608Gerboni 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EmbracePlus in people with Oximetry, run by Empatica, Inc. at 1 site in United States.
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 4 inclusion and 16 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 25 Nov 2022. 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 United States. 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?
SpO2 Accuracy (time frame: Through study completion, 3 months average). 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 NCT04964609, which also lists 1 linked publication.
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 25 Nov 2022.