HypoxiaNCT04446247

Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia

An observational study of Hypoxia, run by Owlet Baby Care, Inc. at 1 site in United States.

Completed

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

Trial summary

Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Hypoxia
What is being tested?: Owlet Smart Sock Sensor 3rd Generation
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 12 Mar 2020to 13 Mar 2020
Phase: Observational
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 49 years
All sexes
Healthy volunteers accepted
Adult

Study population: Participants in this study should be healthy, between 18 and 50 years of age and willing to participate in breathing studies with or without blood samples in San Francisco.

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.

Show all 16Show fewer

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

University California San Fransisco, Department of Anesthesia
San Francisco, California, 94133

Other trials in United States

About this study

Conditions: Hypoxia
Being tested: Owlet Smart Sock Sensor 3rd Generation
Keywords: Verification of SpO2 accuracy, Induced hypoxia, Owlet Smart Sock, Pulse oximeter
Medical subject headings: Hypoxia

What participants receive

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

Owlet Smart Sock Sensor 3rd GenerationDiagnostic test
Pulse Oximetry

What is being measured

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

SpO2 Accuracy (Arms) of ≤3 Between 70 and 100%
Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation
Measured: 1 hour

Timeline

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

12 Mar 202013 Mar 2020

First posted24 Jun 2020
Study start12 Mar 2020
Primary completion13 Mar 2020
Study completion13 Mar 2020

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: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04446247
Sponsor's protocol ID: 10-00437
Status last verified: Sep 2020
First submitted: 22 Jun 2020
Last updated: 19 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
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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Predict Severe Traumatic Brain Injury
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Impact of Closed PBSC Collection With Reduced Gas-Phase Oxygen Exposure on Graft Quality and Early Engraftment in Allo-HSCT
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Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
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Asphyxia Neonatorum, Fetal Hypoxia
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Chronic Respiratory Failure, Acute Respiratory Failure

All Hypoxia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia
ClinicalTrials.gov ID: NCT04446247
Acronym / sponsor ID: 10-00437
Conditions: Hypoxia
Keywords: Verification of SpO2 accuracy, Induced hypoxia, Owlet Smart Sock, Pulse oximeter
Study type: Observational
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Owlet Baby Care, Inc.Industry (pharma, biotech, devices)
Study start: 12 Mar 2020 (actual)
Primary completion: 13 Mar 2020 (actual)
Study completion: 13 Mar 2020 (actual)
First posted: 24 Jun 2020 (actual)
Results: Posted 19 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: Participants in this study should be healthy, between 18 and 50 years of age and willing to participate in breathing studies with or without blood samples in San Francisco.

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
Owlet Smart Sock Sensor 3rd GenerationPulse Oximetry	Diagnostic test	–

Primary outcome

SpO2 Accuracy (Arms) of ≤3 Between 70 and 100%
Time frame: 1 hour
Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation

Results and safety

Results posted to the registry on 19 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ARMS SpO2 70-100%	14	14

Primary outcome: SpO2 Accuracy (Arms) of ≤3 Between 70 and 100%

Time frame: 1 hour. Number. Unit: Percentage

Measure	ARMS SpO2 70-100%, Oximeter #1 (Left) n = 14	ARMS SpO2 70-100%, Oximeter #2 (Right) n = 14
Value	2.10	2.19

Adverse events

Time frame: Study Duration (approximately 1 hour). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ARMS SpO2 70-100%, Oximeter #1 (Left)	0 of 14 (0%)	0 of 14 (0%)	0 of 14
ARMS SpO2 70-100%, Oximeter #2 (Right)	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hypoxia

RecruitingObservational study
Predict Severe Traumatic Brain Injury
Traumatic Brain Injury
Not yet recruiting
Impact of Closed PBSC Collection With Reduced Gas-Phase Oxygen Exposure on Graft Quality and Early Engraftment in Allo-HSCT
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Oxygen Deficiency
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Recruiting
Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit
Chronic Respiratory Failure, Acute Respiratory Failure

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.

Philip Bickler, MD principal investigator

UCSF Department of Anesthesia

John Feiner, MD principal investigator

UCSF Department of Anesthesia

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

Questions about this trial

What is this clinical trial studying?

An observational study of 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 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 19 Oct 2020. 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 19 Oct 2020). 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?

SpO2 Accuracy (Arms) of ≤3 Between 70 and 100% (time frame: 1 hour). 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 NCT04446247.

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 19 Oct 2020.