Clinical trial NCT03775291: Validation of Software for Assessment of Sleep Apnea From Data Acquired by a Wearable Smartwatch
Official title: Fitbit Sleep Apnea Alert Software Validation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea
Lead sponsor: Fitbit LLC
Sponsor class: INDUSTRY
First posted: 2018-12-13
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of PSG-assessed AHI with multi-night estimate derived from wearable device.
timeFrame: Nightly basis averaged over 7 nights.
Secondary outcomes:
measure: Single night comparison between PSG and wearable device data on a per-subject basis
timeFrame: 1 night
measure: Single night comparison between PSG and wearable device data on a per-epoch basis
timeFrame: 1 night
Other outcomes:
Locations:
city: Jasper
country: United States
facility: Jasper Summit Research
state: Alabama
city: Burlingame
country: United States
facility: Peninsula Sleep Center
state: California
city: Irvine
country: United States
facility: Sleep Center Orange County
state: California
city: Atlanta
country: United States
facility: Neurotrials Inc
state: Georgia
city: Columbia
country: United States
facility: SleepMed Inc
state: South Carolina
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
Study officials:
affiliation: Fitbit LLC
name: Conor Heneghan, PhD
role: STUDY_DIRECTOR
References: