Evaluating the accuracy of a pulse oximeter in low oxygen conditions
Accuracy of the Evie Ring Pulse Oximeter in Profound Hypoxia
This study tests how accurately a new pulse oximeter measures oxygen levels in healthy people when their oxygen is intentionally lowered.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | All |
| Sponsor | Movano Health Industry-sponsored |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06459206 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the accuracy of the EvieMED Ring Pulse Oximeter in measuring oxygen saturation levels in healthy volunteers experiencing induced hypoxia. Participants will have multiple pulse oximeters placed on their hands and wrist while their arterial blood oxygen levels are monitored. The study will compare the readings from the test devices to those from established hospital-grade pulse oximeters and arterial blood gas measurements. The goal is to determine how accurately the new device performs in conditions of low oxygen saturation.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults without any significant medical history or conditions that could affect oxygen saturation readings.
Not a fit: Patients with obesity, heart or lung diseases, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring of oxygen levels in patients with respiratory issues.
How similar studies have performed: Other studies have shown success in evaluating pulse oximeter accuracy, but this specific approach with the EvieMED device is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subject is in good general health with no evidence of any medical problems. Subject is fluent in both written and spoken English. Subject provided written informed consent and is willing to comply with the study procedures. Subject is willing to have their skin color assessed. Exclusion Criteria: Subject is obese with a body mass index (BMI) over 30. Subject has a known history of heart disease, lung disease, kidney or liver disease. Subject has asthma, sleep apnea, or uses continuous positive airway pressure breathing support Subject has diabetes. Subject has a clotting disorder, anemia, or in the opinion of the investigator, they would be unsuitable for participation. Subject has any other serious system illness. Subject is a current smoker. Subject has any injury, deformity, or abnormality at the sensor sites that, in the opinion of the investigator, would interfere with the sensors working correctly. Subject has a history of fainting or vasovagal response. Subject has a sensitivity to local anesthesia. Subject has Raynaud's disease. Subject has unacceptable collateral circulation based on an exam by the investigator. Subject is pregnant, lactating, or trying to get pregnant. Subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study procedures. Subject has any other condition, which in the opinion of the investigator, would make them unsuitable for the study.
Where this trial is running
San Francisco, California
- Hypoxia Research Laboratory — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Philip Bickler, MD, PhD — University of California at San Francisco (UCSF)
- Study coordinator: Kim Tompkins
- Email: ktompkins@movano.com
- Phone: +1 (408) 981-488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.