Scientists develop pill-sized device that monitors breathing from the gut
20 November 2023
By Yvaine Ye
Co-author Ali Rezai, MD, holds the Celero VM Pill (Credit: WVU Rockefeller Neuroscience Institute)
Vitals monitoring pill has potential to diagnose sleep apnea and provide accessible care for people at risk of opioid overdose, researchers say after first human trial.
Scientists have developed an ingestible device that can safely monitor vital signs like breathing and heart rate from inside humans. The tool, described November 17 in the Cell Press journal Device opens in new tab/window, has the potential to provide accessible and convenient care for people at risk of opioid overdose.
“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 first author Dr Giovanni Traverso opens in new tab/window, Associate Professor in the Department of Mechanical Engineering at MIT opens in new tab/window and gastroenterologist at Brigham and Women’s Hospital opens in new tab/window in Boston.
In recent years, scientists have been developing a plethora of ingestible devices. Unlike implantable devices like pacemakers, ingestible devices are easy to use and do not require a surgical procedure. For example, doctors have been using a pill-sized ingestible camera to conduct colonoscopy, a procedure traditionally conducted in a hospital setting.
“The idea of using ingestible device is that a physician can prescribe these capsules, and all the patient needs to do is to swallow it,” said co-author Benjamin Pless opens in new tab/window, founder of Celero Systems opens in new tab/window, a medical device developer based in Massachusetts. “People are accustomed to taking pills, and costs of using ingestible devices are much more affordable than performing traditional medical procedures.”
The vitals monitoring pill, or VM Pill, works by monitoring the small vibrations of the body associated with breathing and the beating heart. The pill can detect if a person stops breathing from the inside of the digestive tract.
Clinical trials
To test the VM Pill, the team placed the device in the stomach of pigs, which were put under anesthesia. Researchers then administered the pigs with a dose of fentanyl that caused the pig to stop breathing, which is what happens during fentanyl overdose in humans. The device measured the pig’s breathing rate in real time and alerted the researchers, who were able to reverse the overdose.
The team also tested the device in humans for the first time by giving the VM Pill to those being evaluated for sleep apnea. Sleep apnea is a disorder in which breathing repeatedly stops and starts during sleep. Many people with the condition remain undiagnosed, in part because diagnosing the condition involves admitting people to a sleep laboratory where they are hooked up to external devices to monitor their vital signs during sleep.
“Given our interest in opioid safety, it came to our attention that sleep apnea has a lot of the same symptoms as opioid-induced respiratory depression,” Pless said.
Researchers gave the VM Pill to 10 patients with sleep apnea at West Virginia University. The device was able to detect when the participants’ breathing stopped and to monitor respiration rate with an accuracy of 92.7%. Compared with external vital monitoring machines, the pill can monitor heart rate with an accuracy of at least 96%. The trial also showed the device is safe, and all participants excreted the device in the few days after the experiment.
Conclusion and next steps
“The accuracy and correlation of these recordings were excellent compared to the clinical gold standard studies we performed in our sleep laboratories,” said co-author Dr Ali Rezai opens in new tab/window, a neuroscientist at the Rockefeller Neuroscience Institute at West Virginia University opens in new tab/window. “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.”
Dr Traverso said the current version of the VM Pill passes through the body in about a day, but there are modifications they can make to the device in the future that would allow it to stay longer for long-term monitoring. In the future, they also hope to upgrade the device so it can deliver drugs to reverse conditions like opioid overdose automatically once the device detects symptoms.
“In the future, there are many situations, including opioid overdose and other respiratory and cardiac conditions, that could certainly benefit from this ingestible device,” Dr Traverso said.
Read the study
Traverso et al: “First-in-human trial of an ingestible vitals monitoring pill opens in new tab/window,” Device (Nov 17, 2023)