Trial Outcomes & Findings for Performance Comparison Between Masimo W1™ and Apple Watch Series 8 (NCT NCT05968079)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

1-6 hours

Results posted on

2025-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	Masimo W1™ and Apple Watch Series 8 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo W1™ and Apple Watch Series 8. Masimo W1™ and Apple Watch Series 8: Noninvasive wearable health monitoring device
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Performance Comparison Between Masimo W1™ and Apple Watch Series 8

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Masimo W1™ and Apple Watch Series 8 n=20 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo W1™ and Apple Watch Series 8. Masimo W1™ and Apple Watch Series 8: Noninvasive wearable health monitoring device
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized African American	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Masimo W1™ n=398 Number of Pairwise Samples All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo W1™ and Apple Watch Series 8. Masimo W1™: Noninvasive wearable health monitoring device	Apple Watch Series 8 n=398 Number of Pairwise Samples All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo W1™ and Apple Watch Series 8. Apple Watch Series 8: Noninvasive wearable health monitoring device
Accuracy of Masimo W1™ and Apple Watch Series 8 in Determining SpO2 (Oxygen Saturation) Values in Subjects During Desaturation Arithmetic Root Mean Square (ARMS)	2.0 Percent of oxygen saturated hemoglobin	2.2 Percent of oxygen saturated hemoglobin
Accuracy of Masimo W1™ and Apple Watch Series 8 in Determining SpO2 (Oxygen Saturation) Values in Subjects During Desaturation Clinical Bias	0.4 Percent of oxygen saturated hemoglobin	0.8 Percent of oxygen saturated hemoglobin
Accuracy of Masimo W1™ and Apple Watch Series 8 in Determining SpO2 (Oxygen Saturation) Values in Subjects During Desaturation Precision	1.9 Percent of oxygen saturated hemoglobin	2.0 Percent of oxygen saturated hemoglobin

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Masimo W1™ n=400 Number of Paired Spot Checks All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo W1™ and Apple Watch Series 8. Masimo W1™: Noninvasive wearable health monitoring device	Apple Watch Series 8 n=400 Number of Paired Spot Checks All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo W1™ and Apple Watch Series 8. Apple Watch Series 8: Noninvasive wearable health monitoring device
Successful Read Rate for Motion Conditions Under Slow Desaturation for Masimo W1™ and Apple Watch Series 8	100 % of Successful Read Values	4.7 % of Successful Read Values

PRIMARY outcome

Timeframe: 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 enrolled into the test group and participate in data collection receive the noninvasive Masimo W1™ and Apple Watch Series 8. Ndesat = Number of All Valid Fast Desaturation Events by Reference SpO2

Outcome measures

Outcome measures
Measure	Masimo W1™ n=187 Number of Valid Events All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo W1™ and Apple Watch Series 8. Masimo W1™: Noninvasive wearable health monitoring device	Apple Watch Series 8 n=187 Number of Valid Events All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo W1™ and Apple Watch Series 8. Apple Watch Series 8: Noninvasive wearable health monitoring device
Detection Rate of Fast Desaturation Events Under Various Conditions for Masimo W1™ and Apple Watch Series 8 Condition 1: No motion, palm facing down, Apple Watch in Sleep Mode	100 Event Detection Rate (%)	7.4 Event Detection Rate (%)
Detection Rate of Fast Desaturation Events Under Various Conditions for Masimo W1™ and Apple Watch Series 8 Condition 2: No motion, palm facing sideways, manual spot checks for Apple Watch	100 Event Detection Rate (%)	24.7 Event Detection Rate (%)

Adverse Events

Masimo W1™ and Apple Watch Series 8

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chelsea Frank

Masimo

Phone: 949-297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place