A wireless, ingestible device that measures vital signs from the gastrointestinal tract could prove useful for diagnosing and monitoring a variety of conditions affecting the respiratory and cardiovascular systems.
The pill represents the first time it has been possible to monitor these physiological measures from the human stomach using a free-floating capsule.
The device is approximately the size of a multivitamin and contains sensors, a microprocessor and radio to assess and transmit respiratory rate and heart rate.
It operates by monitoring small vibrations in the body associated with breathing and the heart beating.
The device offers accessible patient data with wireless transmission and has the benefits of being non-invasive and cheaper than standard procedures, with the potential for greater patient compliance.
Reporting in the journal Device, the researchers suggest it could be useful for diagnosing sleep apnea and detecting overdoses from opiates in people at high risk.
“The ability to facilitate diagnosis and monitor many conditions without having to go into a hospital can provide patients with easier access to healthcare and support treatment,” said researcher Giovanni Traverso, PhD, an associate professor in the department of mechanical engineering at the Massachusetts Institute of Technology and gastroenterologist at Brigham and Women’s Hospital.
Mild obstructive sleep apnea has been estimated to affect 17.4% of women and 33.9% of men in the U.S. between the ages of 30 and 70, with at-home evaluation still requiring wearing and being connected to monitoring devices.
Despite advances with at-home evaluation, more than eight in 10 cases of moderate-to-severe obstructive sleep apnea remain undiagnosed.
Meanwhile, U.S. drug deaths have hit a new record, with preliminary data from 2022 suggesting 109,680 people died in the fentanyl crisis that year.
More than half of opioid overdoses occur when individuals are alone and having one nonfatal overdose increases the risk of others, both fatal and non-fatal.
Early interventions increase the chances for treatment with opiate antagonists, with associated improvements in survival.
In preclinical studies of opioid overdose, Traverso and team found the device could accurately measure breathing and heart rate in pigs.
Then, in a first-in-human study, the researchers gave the VM Pill to 10 patients with sleep apnea.
The data collected showed high concordance with that obtained from standard sleep studies, which involved admission to a facility, placement of multiple skin sensors, and overnight observation.
The pill detected when the participants’ breathing stopped and monitored respiration rate with 92.7% accuracy. Compared with external vital monitoring machines, it was able to monitor heart rate with an accuracy of at least 96%.
All participants excreted the device in days soon after the experiment.
“The accuracy and correlation of these recordings were excellent compared to the clinical gold standard studies we performed in our sleep laboratories,” said researcher Ali Rezai, PhD, a neuroscientist at the Rockefeller Neuroscience Institute.
“The ability to remotely monitor critical vital signals from patients without wires, leads, or need of medical technicians, opens the door for monitoring patients in their natural environments versus the clinic or the hospital setting,” he added.