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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masimo W1™ and Apple Watch Series 8 | Device | Noninvasive wearable health monitoring device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 1-6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Pharmacology and Physiology Laboratory (HPPL) - Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 20 subjects were enrolled for the study
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Percent of oxygen saturated hemoglobin | 1-6 hours | Number of Pairwise Samples | Number of Pairwise Samples |
|
Through study completion, each subject's participation in the study was between 1-6 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Frank | Masimo | 949-297-7000 | clinicalresearchdept@masimo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2023 | Oct 15, 2024 | Prot_SAP_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | 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. Apple Watch Series 8: Noninvasive wearable health monitoring device |
|
|
| 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 | Posted | Number | % of Successful Read Values | 1-6 hours | Number of Paired Spot Checks | Number of Paired Spot Checks |
|
|
|
| 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 | Posted | Number | Event Detection Rate (%) | 1-6 hours | Number of Valid Events | Number of Valid Events |
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| 0 |
| 20 |
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| 20 |
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