HypoxiaNCT03630016
SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
A study testing Pulse oximetry with Owlet BabySat v1.0 sensor in people with Hypoxia, run by Owlet Baby Care, Inc. at 1 site in United States.
Trial summary
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. There are two devices used in this investigational study: BabySat v.1.0 and Owlet Baby Care, Inc. 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?
- Pulse oximetry with Owlet BabySat v1.0 sensor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2017to 17 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance, made up of either.
- Subject must have the ability to understand and provide written informed consent
- Subject is 18 to 50 years of age
- At least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger
- Subject must be willing and able to comply with study procedures and duration
- Subject is a non-smoker or who have not smoked within 2 days prior to the study.
Who cannot join
- Subject is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study
- Females who are pregnant, who are trying to get pregnant
- Smoker Subjects who have refrained will be screened for COHb levels
- Subjects with known heart or cardiovascular conditions
- Subjects with known clotting disorders
Trial locations and contacts
1 site in 1 country.
About this study
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. There are two devices used in this investigational study: BabySat v.1.0 and Owlet Baby Care, Inc. Smart SockTM 2 (currently available over-the-counter), with specific emphasis on its pulse oximetry accuracy. The BabySat and Smart SockTM 2 are non-invasive home care devices for use with infants. The purpose of this study was to validate the SpO2 accuracy of BabySat v1.0 and Owlet Smart SockTM 2, OSS v1.1 sensors pulse oximetry, during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry.
Read the detailed description
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. A pulse oximeter is a device that measures the oxygen saturation of arterial blood non-invasively.
The purpose of this study was to evaluate the SpO2 accuracy performance of the Owlet BabySat v1.0 and Smart SockTM 2 pulse oximetry OSS v1.1 sensors during non-motion conditions over the range of 70-100% SaO2 to arterial blood samples assessed by CO-Oximetry for a SpO2 validation.
The goal, in its entirety, was to show the SpO2 accuracy performance for the investigational device Owlet Baby Care, Inc. Smart SockTM V. 2.
It was expected that the Accuracy Root Mean Square (ARMS) performance would meet the required specification of ARMS 3% or lower in non-motion conditions for the range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.
No risks or adverse device effects were expected. There were no contraindications for use in the proposed study population.
The study was conducted in accordance to the code of federal regulations for non-significant risk medical device studies and applicable ISO 14155 (2nd edition 2011-02-01), applicable sections of ISO80601-2-61 (1st edition 2011-04- 01), and Pulse Oximeters - Premarket Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013)
- Conditions
- Hypoxia
- Being tested
- Pulse oximetry with Owlet BabySat v1.0 sensor
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximetry with Owlet BabySat v1.0 sensorDiagnostic test
A comparative, single-center, non-randomized study to evaluate the SpO2 accuracy guidelines for pulse oximetry over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison with Owlet BabySat v1.0 and Owlet Smart Sock 2 sensors
| Study group | Role | What they receive |
|---|---|---|
| Reference CO-Oximetry | Active comparator | Reference Co-Oximetry Receives: Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensor |
| Owlet BabySat v1.0 | Experimental | Owlet BabySat v1.0 Receives: Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensor |
| Owlet Smart Sock V2 v1.1 | Experimental | Owlet Smart SockTM 2 , OSS v1.1 Sensor and Custom Adult Thumb Sock Receives: Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
It Was Expected That the Accuracy Root Mean Square (ARMS) Between Measured SpO2 of Owlet Smart Sock V2 v1.1 and Reference SpO2 Would Meet the Required Specification of ARMS 3% or Lower in Non-motion Conditions for the Range of 70 - 100%
The purpose of the study was to evaluate the accuracy of the blood oxygen saturation (SpO2) at rest over the range of 70-100% compared to arterial blood samples assessed by standard methods [Co-Oximetry]. A standard pulse oximeter accuracy is evaluated by the Accuracy Root Mean Square (ARMS). The results of accurate performance of the oximetry system require ARMS of 3% or less in non-motion conditions for the range of 70-100% SpO2 per standard.
Measured: Acute immediate assessment of the sensor accuracy compared to CO-oximetry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start13 Dec 2017
- Primary completion17 Dec 2017
- Study completion17 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Owlet Baby Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Responsible party
- Sponsor
- Investigators
- Milena Adamian, MD, Study director, Owlet Baby Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630016
- Sponsor's protocol ID
- PR2017-263
- Status last verified
- Jul 2019
- First submitted
- 3 Aug 2018
- Last updated
- 23 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
- ClinicalTrials.gov ID
- NCT03630016
- Acronym / sponsor ID
- PR2017-263
- Conditions
- Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Owlet Baby Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 17 Dec 2017 (actual)
- Study completion
- 17 Dec 2017 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. There are two devices used in this investigational study: BabySat v.1.0 and Owlet Baby Care, Inc. Smart SockTM 2 (currently available over-the-counter), with specific emphasis on its pulse oximetry accuracy. The BabySat and Smart SockTM 2 are non-invasive home care devices for use with infants. The purpose of this study was to validate the SpO2 accuracy of BabySat v1.0 and Owlet Smart SockTM 2, OSS v1.1 sensors pulse oximetry, during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry.
Detailed description
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. A pulse oximeter is a device that measures the oxygen saturation of arterial blood non-invasively.
The purpose of this study was to evaluate the SpO2 accuracy performance of the Owlet BabySat v1.0 and Smart SockTM 2 pulse oximetry OSS v1.1 sensors during non-motion conditions over the range of 70-100% SaO2 to arterial blood samples assessed by CO-Oximetry for a SpO2 validation.
The goal, in its entirety, was to show the SpO2 accuracy performance for the investigational device Owlet Baby Care, Inc. Smart SockTM V. 2.
It was expected that the Accuracy Root Mean Square (ARMS) performance would meet the required specification of ARMS 3% or lower in non-motion conditions for the range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.
No risks or adverse device effects were expected. There were no contraindications for use in the proposed study population.
The study was conducted in accordance to the code of federal regulations for non-significant risk medical device studies and applicable ISO 14155 (2nd edition 2011-02-01), applicable sections of ISO80601-2-61 (1st edition 2011-04- 01), and Pulse Oximeters - Premarket Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference CO-Oximetry | Active comparator | Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensorReference Co-Oximetry |
| Owlet BabySat v1.0 | Experimental | Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensorOwlet BabySat v1.0 |
| Owlet Smart Sock V2 v1.1 | Experimental | Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensorOwlet Smart SockTM 2 , OSS v1.1 Sensor and Custom Adult Thumb Sock |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance, made up of either.
- Subject must have the ability to understand and provide written informed consent
- Subject is 18 to 50 years of age
- At least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger
- Subject must be willing and able to comply with study procedures and duration
Key exclusion criteria (6 listed)
- Subject is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study
- Females who are pregnant, who are trying to get pregnant
- Smoker Subjects who have refrained will be screened for COHb levels
- Subjects with known heart or cardiovascular conditions
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 |
|---|---|---|
| Pulse oximetry with Owlet BabySat v1.0 sensorA comparative, single-center, non-randomized study to evaluate the SpO2 accuracy guidelines for pulse oximetry over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison with Owlet BabySat v1.0 and Owlet Smart Sock 2 sensors | Diagnostic test | Owlet BabySat v1.0, Owlet Smart Sock V2 v1.1, Reference CO-Oximetry |
Primary outcome
It Was Expected That the Accuracy Root Mean Square (ARMS) Between Measured SpO2 of Owlet Smart Sock V2 v1.1 and Reference SpO2 Would Meet the Required Specification of ARMS 3% or Lower in Non-motion Conditions for the Range of 70 - 100%
Time frame: Acute immediate assessment of the sensor accuracy compared to CO-oximetry
The purpose of the study was to evaluate the accuracy of the blood oxygen saturation (SpO2) at rest over the range of 70-100% compared to arterial blood samples assessed by standard methods [Co-Oximetry]. A standard pulse oximeter accuracy is evaluated by the Accuracy Root Mean Square (ARMS). The results of accurate performance of the oximetry system require ARMS of 3% or less in non-motion conditions for the range of 70-100% SpO2 per standard.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Milena Adamian, MD study director
Owlet Baby Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse oximetry with Owlet BabySat v1.0 sensor in people with Hypoxia, run by Owlet Baby Care, 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 6 inclusion and 6 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 23 Jul 2019. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
It Was Expected That the Accuracy Root Mean Square (ARMS) Between Measured SpO2 of Owlet Smart Sock V2 v1.1 and Reference SpO2 Would Meet the Required Specification of ARMS 3% or Lower in Non-motion Conditions for the Range of 70 - 100% (time frame: Acute immediate assessment of the sensor accuracy compared to CO-oximetry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2019.