Comparison of SpO2 Measurement Accuracy of Different Types of Smartwatches

NCT05789563 | Completed

• 1 other identifier: NVT_01_2023
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxia

Keywords

SpO2; Pulse oximetry; Smartwatch

Outcome Measures

Primary Outcomes (1)

• Similarity of SpO2 readings

  The agreement of SpO2 measurements of every model of smartwatches and reference pulse oximeter will be evaluated

  Under 1 hour

Study Arms (3)

First smartwatch model

EXPERIMENTAL

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 experiment, SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously.

Other: Hypoxia and Smartwatch model

Second smartwatch model

EXPERIMENTAL

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 experiment, SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously.

Other: Hypoxia and Smartwatch model

Third smartwatch model

EXPERIMENTAL

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 experiment, SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously.

Other: Hypoxia and Smartwatch model

Interventions

Hypoxia and Smartwatch model OTHER

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.

First smartwatch model; Second smartwatch model; Third smartwatch model

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Czech Technical University in Prague: lead

Study Sites (1)

Czech Technical University in Prague

Kladno, 27201, Czechia

Location

Related 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.

  PMID: 36249475 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jakub Rafl, PhD.

  Czech Technical University in Prague

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants go through all study arms, in random order. Two measuring devices are active simultaneously during each measurement on each participant and their functioning is compared.

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: March 17, 2023
• Primary Completion: April 30, 2023
• Study Completion: June 28, 2023
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

CZ (1)