Validation of Software for Assessment of Sleep Apnea From Data Acquired by a Wearable Smartwatch

Study Overview
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Brief Summary
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This clinical validation study aims to evaluate the utility of Fitbit's Sleep Apnea Alert software for minimally invasive monitoring of sleep apnea events to alert users of their risk of sleep apnea. The Sleep Apnea Alert software analyses data from a Fitbit commercially available wrist photoplethysmogram (PPG) device. The Sleep Apnea Alert software is an investigational software as medical device (SaMD) and is designed to retrospectively process data and flag users who have physiological signals consistent with an apnea-hypopnea index (AHI) of 15 or greater. This clinical validation study will be used to validate Fitbit's PPG-based sleep apnea algorithm. The outputs of the Fitbit Sleep Apnea Alert software will not be available to study participants, as the scope of this study is to gather validation data only and does not include testing product usability components.

Official Title
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Fitbit Sleep Apnea Alert Software Validation Study

Conditions
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Sleep Apnea

Intervention / Treatment
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* Diagnostic Test: Simultaneous assessment of sleep apnea by polysomnogram and wearable device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable of giving informed consent Comfortable reading the provided written study instructions in English (and/or local language) and using a smartphone in English (and/or local language). Have medical insurance either in the form of private insurance or a national health program. Exclusion Criteria: No implanted cardiac devices Not pregnant. Pregnancy status will be confirmed per patient report of medical history, i.e., patients will be asked if they are pregnant or may be pregnant, and date of last menstrual cycle. No medical conditions which might lead to consistently low levels of perfusion in the vasculature at the wrist

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low pre-test likelihood for sleep apnea<br>Subjects at low risk for having sleep apnea due to lack of known risk factors and no complaints of symptoms related to sleep apnea (e.g., excessive daytime sleepiness) | Diagnostic Test: Simultaneous assessment of sleep apnea by polysomnogram and wearable device<br>* Characterization of sleep apnea by lab-based polysomnogram<br>|
| High pre-test likelihood for sleep apnea<br>Suspected sleep apnea patients who are undergoing sleep tests as part of normal medical care or are also known to be non-compliant with therapy. | Diagnostic Test: Simultaneous assessment of sleep apnea by polysomnogram and wearable device<br>* Characterization of sleep apnea by lab-based polysomnogram<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of PSG-assessed AHI with multi-night estimate derived from wearable device. | Percent agreement between subjects classified as Apnea Hypopnea Index (AHI)≥15 or <15 as determined by a single night of lab based polysomnogram , versus the corresponding estimate (averaged over 7 nights) from the wearable device. [This primary outcome data will also be expressed as per-subject sensitivity and specificity of the wearable device to correctly identify subjects with AHI≥15 and AHI<15 respectively] | Nightly basis averaged over 7 nights. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single night comparison between PSG and wearable device data on a per-subject basis | Percent agreement between subjects classified as Apnea Hypopnea Index (AHI)≥15 or <15 as determined by a single night of lab based polysomnogram , versus the corresponding estimate on the same night as PSG from the wearable device. [This primary outcome data will also be expressed as per-subject sensitivity and specificity of the wearable device to correctly identify subjects with AHI≥15 and AHI<15 respectively] | 1 night | 
| Single night comparison between PSG and wearable device data on a per-epoch basis | Percent agreement on a per one-minute epoch basis for the presence of sleep apnea between the polysomnogram and the corresponding simultaneous estimate from the wearable device . | 1 night |