Advances in wearable technology has made it possible for Owlet to imagine novel applications to support expecting mothers during pregnancy.
Owlet set out to create a pregnancy monitor for consumers that was both safe and comfortable enough for an expecting mother to wear every night while most importantly, delivering accurate heart rate information for both Baby and mom.
The Owlet Band is a wearable fabric band made up of small sensors that are able to detect the natural low-level electrical signals normally produced by the mother’s and baby’s heart, similar to an electrocardiogram technology (ECG).
The Band’s algorithm analyzes these bioelectrical signals to estimate mother’s heart rate, as well as that of the baby’s. As with most wearables, the Band collects data in aggregate form and then delivers consumer facing information to the user primarily to provide general health information.*
Throughout development, Owlet has conducted tests in-house and through third parties to validate the Band’s accuracy in predicting Fetal Heart Rate (FHR) compared to standard fetal heart rate monitoring, cardiotocography (CTG).
Owlet conducted an internal study which collected data from pregnant women of at least 24 weeks gestation while wearing the Band and Corometrics® 170 simultaneously. Each device tracked the fetal heartbeats while the mother rested on her left side in a lateral recumbent position. The image below visualizes our testing protocol.
The validation set included 67 hours of data and 31 participants. Initial findings suggest that the Owlet Band accurately estimates fetal heart rate compared to Corometrics with an average error of +/-2.21 BPM.
Example of one session from the validation dataset:
As a matter of continuing to validate our results with independent parties, a third-party validation study is in progress in partnership with Developmental Neuroscience Lab at Columbia University Irving Medical Center (CUIMC). The intent of the study was to test the accuracy of the Owlet Band using the Corometrics® 170 for comparison. 15 pregnant women over 30 weeks gestation would wear the Band and Corometrics simultaneously for 20 minutes in-clinic and the readings were compared.
Unfortunately, due to the COVID-19 pandemic, CUIMC and New York State Psychiatric Institute enacted restrictions on participant recruitment and non-essential research procedures, essentially halting all human-subject related research, including the Band accuracy study.
Prior to the hold, 6 participants were enrolled as part of the study. The early results are promising, but no conclusion can be determined until the sample size is expanded.
The Developmental Neuroscience Lab at CUIMC intends to continue with enrollment when COVID-19 restrictions are lifted and it is safer for participants to take part in this research again.
Through all of our product lines Owlet is committed to delivering safe and accurate products to our users. The Band can be trusted by moms to accurately provide fetal heart rate. Additional testing and research will continue when COVID-19 restrictions are lifted.
*The Band is an information gathering device designed to help women have a healthy pregnancy and provides sleep position and heartbeat audio at a glance in the Owlet Pregnancy App. It is not a medical device and will not diagnose, cure, treat, alleviate or prevent any disease or health condition.