Accuracy of the Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus

Description

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

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Study Overview

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Study Details

Study overview

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.

Accuracy of the Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus

Accuracy of the Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus

Condition
Hypoxia
Intervention / Treatment

-

Contacts and Locations

San Francisco

Vital Signs Research Group, San Francisco, California, United States, 94107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. The subject is in good general health with no evidence of any medical problems.
  • 2. The subject is fluent in both written and spoken English.
  • 3. The subject has provided informed consent and is willing to comply with the study procedures.
  • 1. The subject is obese (BMI\>35).
  • 2. The subject has a known history of heart disease, lung disease, kidney or liver disease.
  • 3. Diagnosis of asthma, sleep apnea, or use of CPAP.
  • 4. The subject has diabetes.
  • 5. The subject has a clotting disorder.
  • 6. 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.
  • 7. The subject has any other serious systemic illness.
  • 8. The subject has a carboxyhemoglobin level greater than 3% (determined during the first sample)
  • 9. Any injury, deformity, or abnormality at the sensor sites that, in the opinion of the investigators' would interfere with the sensors working correctly.
  • 10. The subject has a history of fainting or vasovagal response.
  • 11. The subject has a history of sensitivity to local anesthesia.
  • 12. The subject has a diagnosis of Raynaud's disease.
  • 13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
  • 14. The subject is pregnant, lactating or trying to get pregnant.
  • 15. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
  • 16. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Ages Eligible for Study

18 Years to 49 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Owlet Baby Care, Inc.,

Koa Gudelunas, STUDY_DIRECTOR, Vital Signs Research Group

Study Record Dates

2025-10-30