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

NCT04446247 | Completed Results

• 1 other identifier: 10-00437
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxia

Keywords

Verification of SpO2 accuracy; Induced hypoxia; Owlet Smart Sock; Pulse oximeter

Outcome Measures

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

  1 hour

Interventions

Owlet Smart Sock Sensor 3rd Generation DIAGNOSTIC_TEST

Pulse Oximetry

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

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.

Sponsors & Collaborators

• Owlet Baby Care, Inc.: lead

Study Sites (1)

University California San Fransisco, Department of Anesthesia

San Francisco, California, 94133, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Madison Kenley, Clinical Research Director
• Organization: Owlet Baby Care, Inc

mkenley@owletcare.com

801-552-8383

Study Officials

• Philip Bickler, MD

  UCSF Department of Anesthesia

  PRINCIPAL INVESTIGATOR

• John Feiner, MD

  UCSF Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: March 12, 2020
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)