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

Sleep Apnea Clinical Trial

Official title:

Fitbit Sleep Apnea Alert Software Validation Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03775291
• Other study ID #: 129-0318-01
• Status: Active, not recruiting
• Start date: November 9, 2018
• Est. completion date: April 30, 2023

Study information

• Verified date: August 2022
• Source: Fitbit Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 303
• Est. completion date: April 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Diagnostic Test:
• Simultaneous assessment of sleep apnea by polysomnogram and wearable device
Characterization of sleep apnea by lab-based polysomnogram

Locations

Country	Name	City	State
Ireland	St Vincent's University Hospital	Dublin
United States	Neurotrials Inc	Atlanta	Georgia
United States	Peninsula Sleep Center	Burlingame	California
United States	SleepMed Inc	Columbia	South Carolina
United States	Sleep Center Orange County	Irvine	California
United States	Jasper Summit Research	Jasper	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Fitbit Inc

Countries where clinical trial is conducted

United States,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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