Validation of Software for Assessment of Sleep Apnea From Data Acquired by a Wearable Smartwatch
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/5/2019 |
| Start Date: | November 9, 2018 |
| End Date: | May 17, 2019 |
| Contact: | Conor Heneghan, PhD |
| Email: | cheneghan@fitbit.com |
| Phone: | 415-513-1000 |
Fitbit Sleep Apnea Alert Software Validation Study
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 in which have physiological signals consistent with subjects who have an
apnea-hypopnea index (AHI) of 10 or greater. This clinical validation study will be used to
validate Fitbit's PPGbased 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.
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 in which have physiological signals consistent with subjects who have an
apnea-hypopnea index (AHI) of 10 or greater. This clinical validation study will be used to
validate Fitbit's PPGbased 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.
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
We found this trial at
5
sites
Burlingame, California 94010
Principal Investigator: Mehran Farid, M.D., FAASM
Phone: 650-779-4055
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Atlanta, Georgia 30342
Principal Investigator: Russell Rosenberg, PhD
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