Ingestible device to monitor vital signs in sleep apnea patients moves to human trials

Diagnosis of vital signs is much comforting when you don't have to be in 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, 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.

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.

“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.” they ended.

Reference: Traverso, Giovanni et al. “First-in-human trial of an ingestible vitals monitoring pill” Device DOI: 10.1016/j.device.2023.100125