Recruiting

Observational Study

Sponsor:

Movano Health

Code:

NCT06459206

Conditions

Hypoxia

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

Pulse oximeter

Study Details

Brief summary:

The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100% per the International Organization for Standardization (ISO) 80601-2-61:2019. Four test devices were placed on each subject on the left or right hand with two at the finger base and two at the fingertip. Motion equipment was used to control motion of the test devices. In addition, two test devices were placed on the contralateral hand on the base of a finger and also on the fingertip. Finally, a test wrist device was placed on either the left or right wrist. SpO2 measurements from these devices were compared to sampling of arterial blood during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.

Conditions

Hypoxia

Study ID

NCT06459206

Start date

Jun 11, 2024

Status verified date

Jun, 2024

Completion date

Jun 13, 2024

Anticipated

Primary completion date

Jun 13, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Adult Volunteers

Minimum of ten (10) subjects meeting the eligibility criteria.

Interventions

Pulse oximeter

Devices (4) were placed on the finger base and the fingertip of two right or left fingers and placed in motion for the duration of the study. Devices (3) were placed on the contralateral side and maintained motionless for the duration of the of study. Blood samples were taken at each stable level of oxygenation.

Primary outcome measure

  • Test devices oxygen saturation accuracy [ Time Frame: 2 days ]

Central Contacts and Locations

Central contacts

Kim Tompkins

+1 (408) 981-488ktompkins@movano.com

Locations

Hypoxia Research Laboratory

Recruiting

San Francisco, California, United States, 94133

More Information

Sponsor

Movano Health

Last update posted

Jun 14, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Movano Health on 2024-06-14.