Clinical trial NCT05968079: Performance Comparison Between Masimo W1™ and Apple Watch Series 8
Official title: Performance Comparison Between Masimo W1™ and Apple Watch Series 8
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Accuracy of Masimo W1™ and Apple Watch Series 8 in Determining SpO2 (Oxygen Saturation) Values in Subjects During Desaturation
timeFrame: 1-6 hours
measure: Successful Read Rate for Motion Conditions Under Slow Desaturation for Masimo W1™ and Apple Watch Series 8
timeFrame: 1-6 hours
measure: Detection Rate of Fast Desaturation Events Under Various Conditions for Masimo W1™ and Apple Watch Series 8
timeFrame: 1-6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Human Pharmacology and Physiology Laboratory (HPPL) - Duke University Medical Center
state: North Carolina
Study officials:
References: