Owlet’s Data Identifies Previously Undetected Increased Prevalence of Cardiac Arrhythmia in Young Infants in Study Published in The Journal of Pediatrics | Business
LEHI, Utah–(BUSINESS WIRE)–Mar 25, 2021–
Owlet Baby Care Inc. announced today that a third-party study using data collected by its flagship product, the Owlet Smart Sock, identified that abnormally high heart rates – a condition known as a tachyarrhythmia – in infants are more common than existing clinical data has shown. The Owlet Smart Sock uses proprietary and innovative pulse-oximetry technology to track a baby’s heart rate, oxygen levels and sleep patterns, contributing to the largest set of infant health and sleep data to date being collected by the Owlet connected ecosystem. While the Smart Sock is a consumer product designed to help new parents gain added insight into their babies’ wellbeing and feel peace of mind, and not a medical device, the findings of this study present significant learnings for clinicians and healthcare professionals working to ensure the safety of babies.
The study, published recently in The Journal of Pediatrics, sought to understand how often this type of heart rate elevation was occurring in babies using direct-to-consumer heart rate monitoring. Although the Owlet Smart Sock is a consumer product and not a medical device, physicians from Cleveland Clinic Children’s, University of Michigan and the University of Utah observed more than 200 million total hours of anonymized data from 100,949 babies monitored by the Owlet Smart Sock. They looked for episodes of tachyarrhythmia, defined in this case as the baby’s heart rate being at or over 240 beats per minute (bpm) for over a minute. For reference, the average resting heart rate of babies less than a year old usually does not exceed 190 bpm. 1
“The growing popularity of at-home heart rate monitors allow for parents to monitor their babies’ activities at a new level and frequency,” said Peter Aziz, MD, pediatric cardiologist at Cleveland Clinic Children’s and an author of the paper. “With this, clinicians should be prepared to provide assurance and counsel parents in the event this type of condition sets off an alarm on their at-home devices. Access to this and more biometric data is likely to increase, which in turn allows us to gather and analyze more data, and ultimately provide insights for the larger benefit of children and their families.”
In looking at the data collected by the Smart Sock, the authors identified 5,070 episodes of tachyarrhythmia in 2,508 babies, representing 2.5% – or about 1 in 40 – of babies in the group. These episodes of tachyarrhythmia were consistent with supraventricular tachycardia (SVT), the most common tachyarrhythmia found in infants. Compared to the 0.10% to 0.25% prevalence of SVT found in other large, population-based hospital studies that included a total of 2,021 and 2,848 individuals with a clinical diagnosis of SVT, respectively, this analysis suggests that SVT may be significantly more common than previously thought. 2,3
“While there is of course more research to be done, the sheer amount of data the Owlet Smart Sock has been able to collect provided a clear view into the true incidence of SVT in the general infant population,” said Jeffrey Humpherys, Ph.D., Research Professor in the Department of Internal Medicine, Division of Epidemiology at the University of Utah School of Medicine, Advisor and former Vice President of Research and Chief Data Scientist at Owlet Baby Care, and a co-author of the paper.
The increased detection of tachyarrhythmia found in this study likely represents a subclinical disease, meaning that it is nearly or completely asymptomatic. Shorter episodes of tachyarrhythmia, though more common than previously thought, resolve quickly enough that heart damage is not likely to occur. However, as side effects of longer episodes may have the potential to cause damage to a baby’s heart, this study provides essential insights and encourages further research. In addition, it should be noted that an electrocardiograph (ECG) is considered the gold standard of diagnosis for instances of SVT, and that while strict criteria was used to define SVT and stringent attempts were made to eliminate false alarms in this study, the Owlet Smart Sock is not a medical device and a clinical diagnosis would have to be verified by a physician and confirmed with an ECG.
The Smart Sock is a part of Owlet’s connected nursery ecosystem and suite of products that uniquely allows for the information parents look for during some of the most crucial moments of their child’s developmental journey.
“We’d like to thank the researchers for their commitment to technology and infant health and are extremely proud of the performance data of the Smart Sock in uncovering episodes of tachyarrhythmia among infants beyond what has clinically existed,” said Kurt Workman, Co-founder and CEO of Owlet Baby Care. “As many of us at Owlet are parents ourselves, we know how important it is for new parents to feel that they have the tools and are connected to the data that will help them keep their babies safe. We look forward to helping facilitate many more impactful studies with the enormous amount of data continuously gathered by our connected nursery.”
The abstract for the paper can be found online at The Journal of Pediatricswebsite.
About Owlet
Owlet was founded by a team of parents in 2012. Owlet’s mission is to empower parents with the right information at the right time, to give them more peace of mind and help them find more joy in the journey of parenting. Owlet’s digital parenting platform aims to give parents real-time data and insights to help parents feel more calm and confident. Owlet believes that every parent deserves peace of mind and the opportunity to feel their well-rested best. Owlet also believes that every child deserves to live a long, happy, and healthy life, and is working to develop products to help facilitate that belief.
References
- Children’s Health. 2021. Normal Heart Rates for Children – Children’s Health. [online]. Available at: https://www.childrens.com/health-wellness/is-your-childs-heart-rate-healthy. Accessed 25 February 2021.
- Wu, M.-H., Chen, H.-C., Kao, F.-Y. & Huang, S.-K. Postnatal cumulative incidence of supraventricular tachycardia in a general pediatric population: A national birth cohort database study. Heart Rhythm 13, 2070–2075 (2016). Available at: https://pubmed.ncbi.nlm.nih.gov/27287032/#:~:text=Abstract,the%20true%20incidence%20is%20unknown.&text=The%20cumulative%20incidence%20was%200.06,%2C%20and%2015%20years%2C%20respectively. Accessed 17 March 2021 .
- Y. Chu, Kevin D. Hill, MD, MS, Reese H. Clark, MD, P. Brian Smith, MD, MPH, MHS, and Christoph P. Hornik, MD, MPH. Treatment of supraventricular tachycardia in infants: analysis of a large multicenter database. Early Hum Dev. Jun; 91(6): 345–350 (2015). Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4433846/. Accessed 17 March 2021.
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CONTACT: Media RelationsCammy Duong
Westwicke, an ICR company
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Mike Cavanaugh
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SOURCE: Owlet Baby Care Inc.
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PUB: 03/25/2021 09:00 AM/DISC: 03/25/2021 09:01 AM
Copyright Business Wire 2021.