Study examines wearable device that reduces opioid overdose risk

Researchers have created a wearable device that can detect and reverse opioid overdoses, according to study results.

The apparatus is intended to be placed on a patient’s stomach. When activated, it behaves like an insulin pump, able to sense when a person stops breathing and moving. When indicated, naloxone is released.

Results were published in Scientific Reports.

"The opioid epidemic has become worse during the pandemic and has continued to be a major public health crisis," Justin Chan, a doctoral student at the University of Washington’s Paul G. Allen School of Computer Science & Engineering, said in a press release. "We have created algorithms that run on a wearable injector to detect when the wearer stops breathing and automatically inject naloxone."

Chan’s team wants to make the new instruments widely available. That would first require approval by the FDA, which recently published specific guidelines for all emergency-use injectors.

Through a multiyear collaboration, the UW investigators worked on the prototype with West Pharmaceutical Services to develop a subcutaneous injector that could safely administer medication. The research team combined the injector system with sensors and created an algorithm that can identify life-threatening patterns of respiration when patients experience opioid toxicity.

The pilot device features two accelerometers that assess respiration, with an onboard processor that detects the cessation of movement linked to breathing. The apparatus, which was already given the go-ahead for production in the U.S., activates the injector when sensing prolonged breathing irregularities or interruptions. The device can also transmit data about breathing rates via Bluetooth.

To test the machine, a clinical study was undertaken with 25 volunteers in a supervised injection facility in Vancouver, B.C. Another trial, this one held in a hospital, featured 20 volunteers who were asked to simulate apneic episodes.

Sensors accurately tracked respiration rates among people with opioid use disorder. The device also detected instances of nonmedical, opioid-induced apnea, which is a sign that a potentially fatal overdose may occur. The testing in Vancouver was limited to measuring breathing patterns to develop a respiratory algorithm and did not involve injection of naloxone. Naloxone was only used in the second study involving healthy human volunteers who were opioid free.

In the second study, participants simulated overdosing by breathing normally and then holding their breath 15 seconds. When the system detected no movement for at least 15 seconds, it activated and injected naloxone into the wearer.

Blood taken from study participants after the machine activated confirmed that the system could deliver the antidote into the circulatory system, thereby demonstrating its potential to reverse overdoses.

"We have enjoyed collaborating with the UW research team at bringing together this expertise in cutting-edge biosensing and wearable drug-delivery technologies," Alex Lyness, senior manager of research and technology at West Pharmaceuticals, said in the release.

"We are pleased to have been able to contribute to this project and prototype system that is intent on solving such a significant unmet need."

According to researchers, further studies will be needed to assess the comfort and detectability of the apparatus for longer periods of time —particularly in unsupervised settings — as well as to properly evaluate naloxone injection in people who use opioids for nonmedical purposes.

Reference:

Wearable device can detect and reverse opioid overdose. https://www.newswise.com/articles/wearable-device-can-detect-and-reverse-opioid-overdose?sc=mwhr&xy=10024694. Published Nov. 19, 2021. Accessed Nov. 23, 2021.