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

NCT03775291 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 303

Last updated 2022-08-22

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Simultaneous assessment of sleep apnea by polysomnogram and wearable device

Characterization of sleep apnea by lab-based polysomnogram

Sponsors & Collaborators

  • Fitbit LLC

    lead INDUSTRY

Principal Investigators

  • Conor Heneghan, PhD · Fitbit LLC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-09
Primary Completion
2022-12-31
Completion
2023-04-30

Countries

  • United States
  • Ireland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03775291 on ClinicalTrials.gov