Using an innovative wearable, Spire Health has launched a study to develop new digital biomarkers that can predict exacerbations—and potentially hospitalizations—in patients with severe chronic obstructive pulmonary disease (COPD).
Spire’s Health Tag respiratory tracker takes a set-it-and-forget-it approach: delivered by the pack, a user can stick the sensors semi-permanently onto the insides of commonly worn pieces of clothing, such as underwear. Machine washable and dryer-safe, their battery life is good for at least a year and also records physical activity, heart rates and sleep.
Those features are important for more than just simple convenience, Spire CEO Jonathan Palley told FierceMedTech, with device adherence remaining a key challenge in gathering robust data on COPD and its progression.
“You've got a population that is sick, elderly and not very tech savvy,” Palley said. “And the reality is that traditional monitoring and wearable devices have not worked well in this group of patients, for obvious reasons.”
To make a truly unobtrusive wearable, Spire had to start from the ground up. “You do not notice it,” he said. “The trick is that we didn't just build a device where we took off-the-shelf sensors and put them together—we literally built the sensor technology up from the material level.”
The company’s observational study has already enrolled more than 100 participants, with the goals of developing new digital biomarkers that can be implemented as part of a COPD remote monitoring program as well as to gauge the Health Tag’s usage.
Palley estimates many hospital stays related to COPD exacerbations could be prevented, either by managing doses earlier or by introducing new medications. “But it doesn't happen as much as it should, and it doesn't happen because the hospitals, physicians and care teams don't know what's happening with the patient at home,” he said.
Most importantly, the device doesn’t just log a person’s respiratory rate. By measuring the full motion of every breath—in and out, 24/7—the Health Tag can provide a waveform that adds a measurable dimension of respiratory quality.
“Think of it kind of like an ECG for breathing,” Palley said. “So we’re getting all these interesting patterns … you start seeing changes in the breathing pattern, and the way the breath looks, as the patient starts worsening in the lead-up to hospitalization.”
The study’s preliminary data and compliance have both been promising, the company said, as Spire continues to develop its prediction algorithm. The device’s continuous monitoring allows tracking potential biomarkers across a day’s typical fluctuations.
“When you look at literally every single breath someone takes throughout a day, and then look at how that distribution of breaths changes day to day, that is very meaningful,” he said.