Scientists in Massachusetts and West Virginia have developed and tested a wireless ingestible device, allowing for remote monitoring of vital signs. This groundbreaking collaborative study involves Brigham and Women’s Hospital, MIT, Celero Systems, and West Virginia University and introduces the Vitals Monitoring Pill (VM Pill), a wireless ingestible device designed to accurately report vital signs such as heart and respiratory rate. In a pilot clinical study involving 10 individuals with sleep apnea, the VM Pill demonstrated its potential to transform how life-threatening events are monitored and prevented, offering a non-intrusive approach to tracking vital signs. Published in Device, the study highlights the broad applications of this device, with a focus on improving sleep apnea monitoring and addressing opioid-induced respiratory depression.
The wearable and portable nature of such monitoring devices contributes to early detection and intervention, key for promoting survival. Patients with sleep apnea, a condition affecting millions of adults, can benefit from non-intrusive vital sign tracking, eliminating the need for cumbersome monitoring devices. The VM Pill also addresses challenges in monitoring opioid-induced respiratory depression, a primary concern in the context of the opioid epidemic. Current vital sign monitors are often bulky and impractical for use without supervision, particularly during overdoses that frequently occur outside medical facilities. In preclinical models, the VM Pill demonstrated accurate vital sign measurements, with data relayed to a receiver attached to a laptop. The first-in-human pilot clinical study involved collecting 57 hours of data from ten subjects at the West Virginia University Medicine Sleep Evaluation Center. The VM Pill accurately captured respiratory and heart rate data comparable to existing monitoring devices, revealing respiratory rhythms within the expected range of 9 to 25 breaths per minute and cardiac signals within the range of 40 to 95 beats per minute. Importantly, the device successfully detected moments of breath cessation, whether intentional or during sleep apnea events, without interference from external monitoring devices. Radiograph imaging confirmed the safe excretion of the device in all subjects after the study. The study also tested the VM Pill in a preclinical model of fentanyl overdose, demonstrating its ability to detect respiratory depression within a minute of overdose in real-time.
While the study notes the limitations of evaluating sleep apnea in subjects at rest, the researchers envision future applications, including monitoring during gastrointestinal procedures lasting up to a week and unobtrusive detection of overdoses. Giovanni Traverso emphasizes the tangible commercial value of this study, indicating that ingestible vital monitors have the potential to revolutionize our ability to respond rapidly to life-threatening events. “We have developed an ingestible electronic capsule that detects different movements associated with specific vital signs. We anticipate that there will be broad applications for this device, with the potential to improve monitoring for sleep apnea and other breathing conditions.” Celero Systems, founded in 2017, aims to develop and commercialize ingestible electronic devices like the VM Pill, with Traverso serving as a founder and board member of the company. This study herefore introduces a groundbreaking approach to vital sign monitoring through the VM Pill, offering a promising avenue for non-intrusive and efficient detection of life-threatening conditions such as sleep apnea and opioid-induced respiratory depression. The findings open possibilities for further research and applications, marking a notable advancement in healthcare technology.
