Healthy VolunteersNCT05968079

Performance Comparison Between Masimo W1™ and Apple Watch Series 8

A study testing Masimo W1™ and Apple Watch Series 8 in people with Healthy Volunteers, run by Masimo Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Masimo W1™ and Apple Watch Series 8
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 6 Sep 2023to 11 Oct 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject is 18 to 55 years of age.
Subject is American Society Anesthesiologist status 1 (ASA I)
Subject has a BMI between 18 and 35.
Subject is able to read and communicate in English and understands the study and the risks involved.

Who cannot join

Subject is currently taking any medications which in the opinion of the principal investigator would not be suitable for participation in the study.
Subject is wearing nail polish that cannot be removed, gel nails, and/or acrylic nails that can interfere with study device's placement.
Participants with conditions or skin abnormalities at or around site of sensor placement that could affect the placement on the sensor or prevent monitoring of physiological parameters during the study, such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown.
Subject has participated in an investigational drug study within one month prior to the start of the study.
Subject has failed the Allen's Test to confirm patency of the collateral artery.
Subject is female with a positive pregnancy test, or is female and is unwilling to use effective birth control between the time of screening and study termination.

Show all 16Show fewer

Subject has a positive urine cotinine or drug test.
Subject has a reported allergy to Lidocaine.
Subject has clinically significant anemia or other hemoglobinopathy.
Subject has a room air saturation of less than 95% by pulse oximetry.
Subject has a clinically significant abnormal EKG.
Subject has a clinically significant abnormal pulmonary function test via spirometry.
Subject is intolerant to a breathing mask apparatus.
Subject has a COHb greater than 3%, or MetHb greater than 2% verified by laboratory co-oximeter.
Subject has another condition, which in the opinion of the principal investigator would not be suitable for participation in the study.
Subject is unwilling or unable to provide informed consent or comply with the study procedures.

Trial locations and contacts

1 site in 1 country.

United States1 site

Human Pharmacology and Physiology Laboratory (HPPL) - Duke University Medical Center
Durham, North Carolina, 27705

Other trials in United States

About this study

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.

Conditions: Healthy Volunteers
Being tested: Masimo W1™ and Apple Watch Series 8

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Masimo W1™ and Apple Watch Series 8Device
Noninvasive wearable health monitoring device

Study groups in NCT05968079
Study group	Role	What they receive
Masimo W1™ and Apple Watch Series 8	Experimental	All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo W1™ and Apple Watch Series 8. Receives: Device: Masimo W1™ and Apple Watch Series 8

What is being measured

The primary outcome is the main question the study is designed to answer.

Accuracy of Masimo W1™ and Apple Watch Series 8 in Determining SpO2 (Oxygen Saturation) Values in Subjects During Desaturation
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.
Measured: 1-6 hours
Successful Read Rate for Motion Conditions Under Slow Desaturation for Masimo W1™ and Apple Watch Series 8
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
Measured: 1-6 hours
Detection Rate of Fast Desaturation Events Under Various Conditions for Masimo W1™ and Apple Watch Series 8
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
Measured: 1-6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 202311 Oct 2023

First posted1 Aug 2023
Study start6 Sep 2023
Primary completion11 Oct 2023
Study completion11 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05968079
Sponsor's protocol ID: MACL0003
Status last verified: Apr 2025
First submitted: 13 Jul 2023
Last updated: 9 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance Comparison Between Masimo W1™ and Apple Watch Series 8
ClinicalTrials.gov ID: NCT05968079
Acronym / sponsor ID: MACL0003
Conditions: Healthy Volunteers
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Masimo CorporationIndustry (pharma, biotech, devices)
Study start: 6 Sep 2023 (actual)
Primary completion: 11 Oct 2023 (actual)
Study completion: 11 Oct 2023 (actual)
First posted: 1 Aug 2023 (actual)
Results: Posted 9 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Masimo W1™ and Apple Watch Series 8	Experimental	Device: Masimo W1™ and Apple Watch Series 8All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo W1™ and Apple Watch Series 8.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Subject is 18 to 55 years of age.
Subject is American Society Anesthesiologist status 1 (ASA I)
Subject has a BMI between 18 and 35.
Subject is able to read and communicate in English and understands the study and the risks involved.

Key exclusion criteria (16 listed)

Subject is currently taking any medications which in the opinion of the principal investigator would not be suitable for participation in the study.
Subject is wearing nail polish that cannot be removed, gel nails, and/or acrylic nails that can interfere with study device's placement.
Participants with conditions or skin abnormalities at or around site of sensor placement that could affect the placement on the sensor or prevent monitoring of physiological parameters during the study, such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown.
Subject has participated in an investigational drug study within one month prior to the start of the study.
Subject has failed the Allen's Test to confirm patency of the collateral artery.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Masimo W1™ and Apple Watch Series 8Noninvasive wearable health monitoring device	Device	Masimo W1™ and Apple Watch Series 8

Primary outcome

Accuracy of Masimo W1™ and Apple Watch Series 8 in Determining SpO2 (Oxygen Saturation) Values in Subjects During Desaturation
Time frame: 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.
Successful Read Rate for Motion Conditions Under Slow Desaturation for Masimo W1™ and Apple Watch Series 8
Time frame: 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
Detection Rate of Fast Desaturation Events Under Various Conditions for Masimo W1™ and Apple Watch Series 8
Time frame: 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

Results and safety

Results posted to the registry on 9 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Masimo W1™ and Apple Watch Series 8	20	20

Primary outcome: Accuracy of Masimo W1™ and Apple Watch Series 8 in Determining SpO2 (Oxygen Saturation) Values in Subjects During Desaturation

Time frame: 1-6 hours. Number. Unit: Percent of oxygen saturated hemoglobin

Measure	Masimo W1™ n = 20	Apple Watch Series 8 n = 20
Clinical Bias	0.4	0.8
Precision	1.9	2.0
Arithmetic Root Mean Square (ARMS)	2.0	2.2

Primary outcome: Successful Read Rate for Motion Conditions Under Slow Desaturation for Masimo W1™ and Apple Watch Series 8

Time frame: 1-6 hours. Number. Unit: % of Successful Read Values

Measure	Masimo W1™ n = 20	Apple Watch Series 8 n = 20
Value	100	4.7

Primary outcome: Detection Rate of Fast Desaturation Events Under Various Conditions for Masimo W1™ and Apple Watch Series 8

Time frame: 1-6 hours. Number. Unit: Event Detection Rate (%)

Measure	Masimo W1™ n = 20	Apple Watch Series 8 n = 20
Condition 1: No motion, palm facing down, Apple Watch in Sleep Mode	100	7.4
Condition 2: No motion, palm facing sideways, manual spot checks for Apple Watch	100	24.7

Adverse events

Time frame: Through study completion, each subject's participation in the study was between 1-6 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Masimo W1™ and Apple Watch Series 8	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Masimo W1™ and Apple Watch Series 8 in people with Healthy Volunteers, run by Masimo Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of Masimo W1™ and Apple Watch Series 8 in Determining SpO2 (Oxygen Saturation) Values in Subjects During Desaturation (time frame: 1-6 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05968079.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.