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

NCT03775291 | Unknown

• 1 other identifier: 129-0318-01
• Study Type: observational
• Target: 303
• Locations: 2 countries
• Sites: 6

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.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Single night comparison between PSG and wearable device data on a per-subject basis

  1 night

• Single night comparison between PSG and wearable device data on a per-epoch basis

  1 night

Study Arms (2)

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

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

Interventions

Simultaneous assessment of sleep apnea by polysomnogram and wearable device DIAGNOSTIC_TEST

Characterization of sleep apnea by lab-based polysomnogram

High pre-test likelihood for sleep apnea; Low pre-test likelihood for sleep apnea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fitbit LLC: lead

Study Sites (6)

Jasper Summit Research

Jasper, Alabama, 35501, United States

Location

Peninsula Sleep Center

Burlingame, California, 94010, United States

Location

Sleep Center Orange County

Irvine, California, 92604, United States

Location

Neurotrials Inc

Atlanta, Georgia, 30342, United States

Location

SleepMed Inc

Columbia, South Carolina, 29201, United States

Location

St Vincent's University Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Conor Heneghan, PhD

  Fitbit LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 13, 2018
• Study Start: November 9, 2018
• Primary Completion: December 31, 2022
• Study Completion: April 30, 2023
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); US (5)