Comparison of SpO2 Measurement Accuracy of Different Types of Smartwatches

Hypoxia Clinical Trial

— CSMADTS  

Official title:

Comparison of SpO2 Measurement Accuracy of Different Types of Smartwatches

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05789563
• Other study ID #: NVT_01_2023
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 17, 2023
• Est. completion date: June 28, 2023

Study information

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

Clinical Trial Summary

The aim of the study is to compare the accuracy of peripheral blood oxygen saturation measurements using smartwatches from three manufacturers compared to a standard medical pulse oximeter.

Description:

The aim is to create a study that compares multiple smartwatch models simultaneously with a standard medical pulse oximeter using a single measurement methodology. According to the available literature, no such study exists. The methodology of the study and the subsequent statistical evaluation are based on the guidelines of the standard ČSN EN ISO 80601-2-61, which specifies requirements for the basic safety and necessary functionality of pulse oximetry devices. The comparison will be performed non-invasively in healthy volunteers during gradual desaturation in the range of 70-100 % SpO2 (normobaric hypoxia). The data obtained could help to increase the awareness of the possibilities of SpO2 monitoring using smartwatches in medical conditions that are manifested by a decrease in SpO2 level over a longer time period, where measurement with a conventional oximeter is impractical.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 18
• Est. completion date: June 28, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

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

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

Intervention

Other:
• Hypoxia and Smartwatch model
Breathing mixtures of O2 (14 %, 12 %, 10 %) balanced with N2 and monitoring SpO2 by one of the smartwatch models on left wrist and by pulse oximeter on left index finger.

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	Similarity of SpO2 readings	The agreement of SpO2 measurements of every model of smartwatches and reference pulse oximeter will be evaluated	Under 1 hour