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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low pre-test likelihood for sleep apnea | 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) |
| |
| High pre-test likelihood for sleep apnea | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simultaneous assessment of sleep apnea by polysomnogram and wearable device | Diagnostic Test | Characterization of sleep apnea by lab-based polysomnogram |
|
| 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. |
| 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] |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects referred to sleep labs for a clinical evaluation or subjects with previous sleep apnea who are known to be non-compliant with treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Conor Heneghan, PhD | Fitbit LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jasper Summit Research | Jasper | Alabama | 35501 | United States | ||
| Peninsula Sleep Center |
No: There is not a plan to make IPD available.
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| 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 |
| Burlingame |
| California |
| 94010 |
| United States |
| Sleep Center Orange County | Irvine | California | 92604 | United States |
| Neurotrials Inc | Atlanta | Georgia | 30342 | United States |
| SleepMed Inc | Columbia | South Carolina | 29201 | United States |
| St Vincent's University Hospital | Dublin | Ireland |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |