NCT03775291

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

Fitbit Sleep Apnea Alert Software Validation Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 303 (actual)
• Sponsor: Fitbit LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep Apnea

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Simultaneous assessment of sleep apnea by polysomnogram and wearable device	Characterization of sleep apnea by lab-based polysomnogram

Timeline

• Start date: 2018-11-09
• Primary completion: 2022-12-31
• Completion: 2023-04-30
• First posted: 2018-12-13
• Last updated: 2022-08-22

Locations

6 sites across 2 countries: United States, Ireland