Healthy Volunteers
Conditions
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.
Interventions
DEVICEMasimo W1™ and Apple Watch Series 8
Noninvasive wearable health monitoring device
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Masimo W1™ and Apple Watch Series 8 in Determining SpO2 (Oxygen Saturation) Values in Subjects During Desaturation | 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 | 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 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Masimo W1™ and Apple Watch Series 8 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Race/Ethnicity, Customized African American | 4 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 7 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants |
| Race/Ethnicity, Customized White | 6 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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.
Time frame: 1-6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Masimo W1™ | 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 |
| Masimo W1™ | 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 |
| Masimo W1™ | 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 |
| Apple Watch Series 8 | Accuracy of Masimo W1™ and Apple Watch Series 8 in Determining SpO2 (Oxygen Saturation) Values in Subjects During Desaturation | Clinical Bias | 0.8 Percent of oxygen saturated hemoglobin |
| Apple Watch Series 8 | Accuracy of Masimo W1™ and Apple Watch Series 8 in Determining SpO2 (Oxygen Saturation) Values in Subjects During Desaturation | Precision | 2.0 Percent of oxygen saturated hemoglobin |
| Apple Watch Series 8 | Accuracy of Masimo W1™ and Apple Watch Series 8 in Determining SpO2 (Oxygen Saturation) Values in Subjects During Desaturation | Arithmetic Root Mean Square (ARMS) | 2.2 Percent of oxygen saturated hemoglobin |
Primary
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
Time frame: 1-6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Masimo W1™ | 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 (%) |
| Masimo W1™ | 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 (%) |
| Apple Watch Series 8 | 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 | 7.4 Event Detection Rate (%) |
| Apple Watch Series 8 | 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 | 24.7 Event Detection Rate (%) |
Primary
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
Time frame: 1-6 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Masimo W1™ | Successful Read Rate for Motion Conditions Under Slow Desaturation for Masimo W1™ and Apple Watch Series 8 | 100 % of Successful Read Values |
| Apple Watch Series 8 | Successful Read Rate for Motion Conditions Under Slow Desaturation for Masimo W1™ and Apple Watch Series 8 | 4.7 % of Successful Read Values |