NCT05968079

Performance Comparison Between Masimo W1™ and Apple Watch Series 8

Completed Results posted Last updated 9 April 2025

What this trial tests

trial testing Masimo W1™ and Apple Watch Series 8 in Healthy Volunteers in 20 participants. Completed in 11 October 2023.

Timeline

6 September 2023

Primary endpoint
11 October 2023

11 October 2023

Quick facts

Lead sponsor	Masimo Corporation
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	20
Start date	6 September 2023
Primary completion	11 October 2023
Estimated completion	11 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Masimo W1™ and Apple Watch Series 8

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Masimo Corporation — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Accuracy of Masimo W1™ and Apple Watch Series 8 in Determining SpO2 (Oxygen Saturation) Values in Subjects During Desaturation Primary · 1-6 hours

Accuracy will be determined by comparing Masimo W1™ SpO2 measurements and Apple Watch Series 8 SpO2 measurements with FDA-cleared pulse oximetry device SpO2 measurements and calculating the Arithmetic root mean square (ARMS) value. All values presented below for SpO2 (Bias, Precision and ARMS) are in units of %. The pairwise samples consist of paired SpO2 timing measurements from both the reference sensor, Masimo W1, and the Apple Watch.

Clinical Bias

Group	Value	95% CI
Masimo W1™	0.4
Apple Watch Series 8	0.8

Precision

Group	Value	95% CI
Masimo W1™	1.9
Apple Watch Series 8	2.0

Arithmetic Root Mean Square (ARMS)

Group	Value	95% CI
Masimo W1™	2.0
Apple Watch Series 8	2.2

Successful Read Rate for Motion Conditions Under Slow Desaturation for Masimo W1™ and Apple Watch Series 8 Primary · 1-6 hours

This analysis examines the successful read rates for motion conditions during slow desaturation events for the Masimo W1™ and Apple Watch Series 8. The motion condition consists of a combined value representing three types of simulated motion: drinking, scratching the nose, and checking the time. Successful Read Rate = 1 - No Read Rate (Nf / Nspotcheck) x 100 (%) Nf = Number of Reads without Valid SpO2 Nspotcheck = Number of All Spot Checks

Group	Value	95% CI
Masimo W1™	100
Apple Watch Series 8	4.7

Detection Rate of Fast Desaturation Events Under Various Conditions for Masimo W1™ and Apple Watch Series 8 Primary · 1-6 hours

Comparison of the detection rate of fast desaturation events under different conditions for the Masimo W1™ and Apple Watch Series 8. The first condition involves no motion, with the palm facing down and the Apple Watch in sleep mode, while the second condition involves no motion, with the palm facing sideways and manual spot checks performed on the Apple Watch. The goal is to evaluate the performance of both devices in detecting desaturation events under these varying circumstances. Detection Rate = (Nt / Ndesat) x 100 (%) Nt = Number of Detected Event by Test Device All subjects who are enr

Condition 1: No motion, palm facing down, Apple Watch in Sleep Mode

Group	Value	95% CI
Masimo W1™	100
Apple Watch Series 8	7.4

Condition 2: No motion, palm facing sideways, manual spot checks for Apple Watch

Group	Value	95% CI
Masimo W1™	100
Apple Watch Series 8	24.7

Sponsor's own description

This study is also designed to compare the performance of Masimo W1™ and Apple Watch Series 8 against FDA cleared hospital grade pulse oximetry technology under desaturation conditions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.