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

SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Hypoxia; Pulse Oximetry
• Intervention / Treatment: Other: Breathing mixtures of O2 and N2 and monitoring SpO2 on finger and left wrist

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Kladno, Czechia, 27201
    • Czech Technical University in Prague

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hypoxia; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Czech Technical University in Prague
• Investigators: Principal Investigator: Simon Walzel, MSc., Czech Technical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2022
• Primary Completion (Anticipated): May 20, 2023
• Study Completion (Anticipated): December 20, 2023

Study Registration Dates

• First Submitted: December 10, 2022
• First Submitted That Met QC Criteria: December 10, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: NVT02/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No