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CompletedNCT04446247Updated Oct 19, 2020Results posted

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

An observational study in Hypoxia, sponsored by Owlet Baby Care, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Owlet Baby Care, Inc. · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
14
Ages
18 Years to 49 Years
Sex
All
01

Study 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. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.

02

Conditions studied

  • Hypoxia

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Keywords

  • Verification of SpO2 accuracy
  • Induced hypoxia
  • Owlet Smart Sock
  • Pulse oximeter
03

In context

Hypoxia

1,232 studies on the registry are indexed under Hypoxia; 242 are open to participants now.

This study's enrollment of 14 is below the median of 67 across 335 observational studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Owlet Baby Care, Inc. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
14 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testOwlet Smart Sock Sensor 3rd Generation

    Pulse Oximetry

06

What researchers measure

Primary outcomes

  1. SpO2 Accuracy (Arms) of ≤3 Between 70 and 100%

    Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation

    Time frame: 1 hour

07

Results

Posted Oct 19, 2020

Participant flow

Participant flow — Overall Study
MilestoneARMS SpO2 70-100%
Started14
Completed14
Not completed0

Outcome measures

PrimarySpO2 Accuracy (Arms) of ≤3 Between 70 and 100%

Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation

Time frame:
1 hour
Reported as:
Number · Percentage
SpO2 Accuracy (Arms) of ≤3 Between 70 and 100%
PercentageARMS SpO2 70-100%, Oximeter #1 (Left)ARMS SpO2 70-100%, Oximeter #2 (Right)
SpO2 Accuracy (Arms) of ≤3 Between 70 and 100%2.102.19

Adverse events

Collected over Study Duration (approximately 1 hour). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ARMS SpO2 70-100%, Oximeter #1 (Left)0/14 (0%)0/14 (0%)0/14 (0%)
ARMS SpO2 70-100%, Oximeter #2 (Right)0/14 (0%)0/14 (0%)0/14 (0%)

Baseline characteristics

14 Healthy volunteer subjects

Age, Categorical
Age, Categorical(Participants)ARMS SpO2 70-100%
<=18 years0
Between 18 and 65 years14
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)ARMS SpO2 70-100%
Female6
Male8
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ARMS SpO2 70-100%
American Indian or Alaska Native0
Asian6
Native Hawaiian or Other Pacific Islander0
Black or African American1
White5
More than one race2
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)ARMS SpO2 70-100%
United States14
Skin Tone
Skin Tone(Participants)ARMS SpO2 70-100%
Dark1
Dark-Medium4
Medium4
Light- Medium4
Light1
08

Study locations

1 site
  • University California San Fransisco, Department of Anesthesia
    San Francisco, California 94133, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 22, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04446247
Lead sponsor
Owlet Baby Care, Inc.
Responsible party
Sponsor
First posted
Jun 24, 2020
Start date
Mar 12, 2020
Primary completion
Mar 13, 2020
Completion
Mar 13, 2020
Results posted
Oct 19, 2020
Last update
Oct 19, 2020

Study contacts

Philip Bickler, MD
principal investigator · UCSF Department of Anesthesia
John Feiner, MD
principal investigator · UCSF Department of Anesthesia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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