Sleep Apnea
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTSimultaneous assessment of sleep apnea by polysomnogram and wearable device
Characterization of sleep apnea by lab-based polysomnogram
Sponsors
Fitbit LLC
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of PSG-assessed AHI with multi-night estimate derived from wearable device. | Nightly basis averaged over 7 nights. | 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. \[This primary outcome data will also be expressed as per-subject sensitivity and specificity of the wearable device to correctly identify subjects with AHI≥15 and AHI\<15 respectively\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single night comparison between PSG and wearable device data on a per-subject basis | 1 night | 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. \[This primary outcome data will also be expressed as per-subject sensitivity and specificity of the wearable device to correctly identify subjects with AHI≥15 and AHI\<15 respectively\] |
| Single night comparison between PSG and wearable device data on a per-epoch basis | 1 night | 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 . |
Countries
Ireland, United States
Outcome results
None listed