Performance Comparison Between Masimo W1™ and Apple Watch Series 8

NCT ID: NCT05968079

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-06
• Study Completion Date: 2023-10-11

Brief 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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Masimo W1™ and Apple Watch Series 8

Intervention Type: DEVICE

Noninvasive wearable health monitoring device

Interventions

Masimo W1™ and Apple Watch Series 8

Noninvasive wearable health monitoring device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masimo Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Human Pharmacology and Physiology Laboratory (HPPL) - Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MACL0003

Identifier Type: -

Identifier Source: org_study_id