Ingestible Vital Signs Monitor Shows Promise in First-in-Human Trial

What if, instead of going into a sleep lab or being connected to monitoring devices, a patient could have their risk of obstructive sleep apnea measured by swallowing a pill? A new collaborative study from Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, Massachusetts Institute of Technology, Celero Systems and West Virginia University, evaluated a wireless ingestible device that can accurately report vital signs like heart and respiratory rate. The team tested the device, known as the Vitals Monitoring Pill (VM Pill), in a pilot clinical study of 10 people with sleep apnea. It was also able to detect signs of opioid-induced respiratory depression in a preclinical model. Their results, published in Device, could transform how life-threatening events are monitored and prevented.

“We have developed an ingestible electronic capsule that detects different movements associated with specific vital signs,” said co-corresponding author Giovanni Traverso, MB, BChir, PhD, a gastroenterologist in the Brigham’s Division of Gastroenterology, Hepatology, and Endoscopy. Traverso is also an associate professor of mechanical engineering at MIT. “We anticipate that there will be broad applications for this device, with the potential to improve monitoring for sleep apnea and other breathing conditions.”

The development of wearable and portable monitoring devices can help promote survival through early detection and intervention. Similarly, patients with sleep apnea can also benefit from non-intrusive tracking of vitals. Obstructive sleep apnea, a condition in which the upper airway becomes partially or fully blocked when asleep, affects millions of adults in the United States. Evaluating sleep apnea usually involves connections to complicated monitoring devices that can be burdensome to the patient.

Additionally, the opioid epidemic has led to a dramatic rise in overdoses, fatal episodes of slow and shallow breathing, or respiratory depression. More than half of these overdoses occur when the individual is alone and outside medical facilities, where caregivers and healthcare providers cannot monitor signs of respiratory distress. Existing vital sign monitors are bulky and difficult to use without supervision.

Traverso and his collaborators first demonstrated accurate vital sign measurements by the VM Pill in a preclinical model. Information from the device was relayed to a receiver attached via USB interface to a laptop. They then collected 57 hours of data from ten subjects at the West Virginia University (WVU) Medicine Sleep Evaluation Center for the first-in-human pilot clinical study of the VM Pill.

They found that respiratory and heart rate data captured by the VM Pill was comparable to data from existing monitoring devices. Analysis of the data showed 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.

The device was also able to capture moments when subjects stopped breathing, either by intentionally holding their breath, or during sleep apnea events. Interference from external sleep apnea monitoring devices did not affect signals from the VM Pill. Radiograph imaging after the study confirmed the excretion of the device without incident in all subjects.

In addition, the researchers also tested the device in a preclinical model of fentanyl overdose. The capsule was able to detect respiratory depression caused within a minute of overdose in real-time.

The authors note that their sleep apnea evaluation was limited to subjects who were sleeping or at rest in bed and further evaluation is needed to measure vital signs in a more natural use environment. The animal overdose model was also limited in that the animals were already anesthetized before opioids were administered.

Future work could test the device’s monitoring capabilities during gastrointestinal procedures lasting up to a week, unobtrusive detection of overdoses and interventions for diagnosis of sleep apnea.

“Our study provides a tangible product with real commercial value,” said Traverso, Associate Professor in the Department of Mechanical Engineering at the Massachusetts Institute of Technology. “Ingestible vital monitors can really transform our capacity to rapidly respond to life-threatening events.”

Celero Systems was founded in 2017 to develop and commercialize ingestible electronic devices like the VM Pill. Traverso is a founder and member of the board of directors for the company, which has licensed intellectual property related to the VM Pill from Mass General Brigham.

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Authorship: Additional authors include Victor Finomore, Jr, James Mahoney III, Justin Kupec, Robert Stansbury, Daniel Bacher, Benjamin Pless, Shannon Schuetz, Alison Hayward, Robert Langer, Ali Rezai.

Disclosures: Bacher, Schuetz, and Pless are employees of Celero Systems, Inc. Langer, Hayward and Traverso have a financial interest in Celero Systems, Inc. Rezai is an advisor to Celero Systems, Inc. Bacher and Pless are co-inventors on published patent applications (US20210060317, EP4021271) encompassing the work described. Pless and Traverso are founders and members of the Board of Directors of Celero Systems, Inc.

Paper cited: Traverso, Giovanni et al. “First-in-human trial of an ingestible vitals monitoring pill” Device DOI: 10.1016/j.device.2023.10012