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

Fitbit

Status: Active, not recruiting

Conditions: Sleep Apnea

Treatments: Diagnostic Test: Simultaneous assessment of sleep apnea by polysomnogram and wearable device

Study type: Observational

Funder types: Industry

Identifiers

NCT03775291

129-0318-01

Details and patient eligibility

About

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.

Enrollment: 303 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

303 participants in 2 patient groups

Low pre-test likelihood for sleep apnea

Description:

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)

Treatment:

Diagnostic Test: Simultaneous assessment of sleep apnea by polysomnogram and wearable device

High pre-test likelihood for sleep apnea

Description:

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.

Treatment:

Diagnostic Test: Simultaneous assessment of sleep apnea by polysomnogram and wearable device