Accuracy Of The Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus

NCT06850610 | Completed FDA Device

• 1 other identifier: OWL PR0009
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

This study tests the accuracy of pulse oximeters in a range of arterial oxygen levels from 100% down to 70%. This is done by comparing the test pulse oximeter readings of young, healthy, adult study participants with blood samples drawn from an artery in the wrist during brief plateaus of progressively lower oxygen saturations. The arterial blood sample is processed in a device called a multi-wavelength hemoximeter and compared to the simultaneous oximeter reading. During each set level of oxygen the participant may be asked to have a motion simulator device apply different types of movement to their hands to assess the pulse oximeter's accuracy during motion. This study will be evaluating the Owlet OSS 3.0 sensor, a component in 2 FDA cleared noninvasive pulse oximeters indicated for infants 1-18 months of age. Testing should require approximately an hour and 15 minutes of the participant's time.

Conditions

Hypoxia

Keywords

hypoxia; pulse oximeter; accuracy; Owlet

Outcome Measures

Primary Outcomes (1)

• Pulse Oximeter Accuracy Measures

  * Overall Accuracy: Arms is less than 3%. * Non-Disparate Performance Evaluation 1: Among pairwise comparisons of MST groups 1-4, 5-7, and 8-10, the largest difference in SpO2 bias is less than 3.5% for the interval 70% ≤ SaO2≤ 85% and less than 1.5% for 85%\< SaO2 ≤ 100%. * Non-Disparate Performance Evaluation 2: For a 100-point change in emitter sensor site ITA, the difference in SpO2 bias is less than 3.5% for 70% ≤ SaO2≤ 85% and less than 1.5% for 85%\< SaO2 ≤ 100%

  From enrollment to completion of 6 plateaus of hypoxia over an approximate 75 minute period.

Study Arms (1)

Hypoxia Plateau Protocol

EXPERIMENTAL

Study participants that all undergo standardized plateaus of oxygen desaturation to evaluate the accuracy of the Owlet noninvasive pulse oximeter during motion and nonmotion conditions.

Diagnostic Test: Pulse oximeter accuracy under hypoxic conditions

Interventions

Pulse oximeter accuracy under hypoxic conditions DIAGNOSTIC_TEST

This study will specifically evaluate the accuracy of the Owlet pulse oximeter sensor, currently FDA cleared for infants 1-18 months of age in an expanded hypoxia lab trial.

Hypoxia Plateau Protocol

Eligibility Criteria

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

You may qualify if:

• 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\>35).
• The subject has a known history of heart disease, lung disease, kidney or liver disease.
• Diagnosis of asthma, sleep apnea, or use of CPAP.
• The subject has diabetes.
• The subject has a clotting disorder.
• The subject has 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 has a carboxyhemoglobin level greater than 3% (determined during the first sample)
• 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)

Vital Signs Research Group

San Francisco, California, 94107, United States

Location

Related Publications (4)

• Cohen PR, DiMarco MA, Geller RL, Darrisaw LA. Colorimetric Scale for Skin of Color: A Practical Classification Scale for the Clinical Assessment, Dermatology Management, and Forensic Evaluation of Individuals With Skin of Color. Cureus. 2023 Nov 1;15(11):e48132. doi: 10.7759/cureus.48132. eCollection 2023 Nov.

  PMID: 38046737 BACKGROUND

• Bickler PE, Feiner JR, Severinghaus JW. Effects of skin pigmentation on pulse oximeter accuracy at low saturation. Anesthesiology. 2005 Apr;102(4):715-9. doi: 10.1097/00000542-200504000-00004.

  PMID: 15791098 BACKGROUND

• Okunlola OE, Lipnick MS, Batchelder PB, Bernstein M, Feiner JR, Bickler PE. Pulse Oximeter Performance, Racial Inequity, and the Work Ahead. Respir Care. 2022 Feb;67(2):252-257. doi: 10.4187/respcare.09795. Epub 2021 Nov 12.

  PMID: 34772785 BACKGROUND

• Sjoding MW, Dickson RP, Iwashyna TJ, Gay SE, Valley TS. Racial Bias in Pulse Oximetry Measurement. N Engl J Med. 2020 Dec 17;383(25):2477-2478. doi: 10.1056/NEJMc2029240. No abstract available.

  PMID: 33326721 BACKGROUND

Related Links

• A guide to the skin tone stratification used for assessment of accuracy across all represented populations.

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

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

Study Officials

• Koa Gudelunas

  Vital Signs Research Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 27, 2025
• Study Start: February 24, 2025
• Primary Completion: August 6, 2025
• Study Completion: August 6, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

US (1)