SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter During Hypoxia

Hypoxia Clinical Trial

— HYPOWATCH  

Official title:

SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05657288
• Other study ID #: NVT02/2022
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 28, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: March 2023
• Source: Czech Technical University in Prague
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the project is to experimentally compare SpO2 measured on a wrist by commercial Smartwach and on a finger measured by a medical-grade pulse oximeter in healthy humans during gradual desaturation in the range of 60-100% SpO2 and simultaneously during a step change from the hypoxic phase to the recovery phase (return to physiological values).

Description:

The newest models of smartwatches measure peripheral blood oxygen saturation (SpO2) and the technology is rapidly improving. The results of individual studies on the accuracy of SpO2 measurement using smartwatches from different brands are still inconclusive. The study aims to compare the measurement of peripheral blood oxygen saturation using the latest smartwatch with a medical-grade pulse oximeter under the condition of normobaric hypoxia. SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. The agreement of the measurements of both devices will be evaluated.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 20, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure, blood oxygen saturation and medical history

Exclusion Criteria:

• pregnancy

• severe cardiovascular conditions

• severe asthma or other severe respiratory conditions

• injury to the upper limbs or hands that could affect the peripheral perfusion

• diabetes

• hypotension or hypertension

Related Conditions & MeSH terms

• Hypoxia
• Pulse Oximetry

Intervention

Other:
• Breathing mixtures of O2 and N2 and monitoring SpO2 on finger and left wrist
Volunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the whole experiment, non-invasive SpO2 measurements will be performed on the middle finger and on the wrist of left hand.

Locations

Country	Name	City	State
Czechia	Czech Technical University in Prague	Kladno

Sponsors (1)

Lead Sponsor	Collaborator
Czech Technical University in Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

Rafl J, Bachman TE, Rafl-Huttova V, Walzel S, Rozanek M. Commercial smartwatch with pulse oximeter detects short-time hypoxemia as well as standard medical-grade device: Validation study. Digit Health. 2022 Oct 11;8:20552076221132127. doi: 10.1177/20552076221132127. eCollection 2022 Jan-Dec. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Is there any difference in measured SpO2 between finger and wrist during induced hypoxia?	The agreement of SpO2 measurements of both monitoring devices will be evaluated.	1 hour