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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03775291
Other study ID # 129-0318-01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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