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

Fitbit Sleep Apnea Alert Software Validation Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep Apnea
• Intervention / Treatment: Diagnostic test: Simultaneous assessment of sleep apnea by polysomnogram and wearable device

• Study Type: Observational
• Enrollment (Actual): 303

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • St Vincent's University Hospital
• United States
  • Alabama
    • Jasper, Alabama, United States, 35501
      • Jasper Summit Research
  • California
    • Burlingame, California, United States, 94010
      • Peninsula Sleep Center
    • Irvine, California, United States, 92604
      • Sleep Center Orange County
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Neurotrials Inc
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Sleepmed Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects referred to sleep labs for a clinical evaluation or subjects with previous sleep apnea who are known to be non-compliant with treatment.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Diagnostic test: Simultaneous assessment of sleep apnea by polysomnogram and wearable device; Characterization of sleep apnea by lab-based polysomnogram
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.	Diagnostic test: Simultaneous assessment of sleep apnea by polysomnogram and wearable device; Characterization of sleep apnea by lab-based polysomnogram

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fitbit Inc
• Investigators: Study Director: Conor Heneghan, PhD, Fitbit Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea
• Other Study ID Numbers: 129-0318-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No