Mountain View, California-based Beddr has launched Sleep Tuner, its first health wearable. The device is an FDA-registered sleep sensor, worn on the forehead, which measures blood oxygenation, heart rate, and sleep position, as well as stopped breathing events.
“The device affixes to the forehead with a medical-grade adhesive, and the adhesive is changed each test night so it’s easy to apply and remove,” Mike Kisch, CEO and cofounder of Beddr, told MobiHealthNews. “And after you test each night the information will be transferred over Bluetooth LE from your smartphone and it will then visualize all of the data that was gathered that particular night and, as you collect multiple nights, it will begin to do analysis related to night-to-night variability. For people who will sort of experiment and try things, they’ll be able to quantify what was the impact of changes they’ve made to their sleep. And within a week, we see people make marked improvement in areas like oxygen levels, fewer stopped breathing events, and longer sleep duration.”
The device has been validated at the UCSF Hypoxia Lab, which found the device had a margin of error of plus or minus 2.2 percent compared to arterial blood draw. The FDA’s allowable margin is plus or minus 3.5 percent.
It’s available for purchase from Beddr’s website for $149.
Why it matters
Kisch says the device is designed to offer the accuracy of medical sleep studies without the cost or inconvenience. He says there are three target users for the device: people who have been diagnosed with a breathing disorder like sleep apnea and are hoping to see how well their treatment is working, people who haven’t been diagnosed but suspect they have a breathing disorder, and people who are diagnosed but aren’t being treated.
“These might be people who have mild to moderate apnea and they found that CPAP was a little bit too invasive of a therapy to them,” he said. “But they’re aware they have a condition that needs to be managed and they want to know what choices do they have to proactively improve their sleep. So they use our device to understand the impact of sleep position or alcohol or consumption or taking non-prescription medications may actually have on increasing their likelihood to have stopped-breathing events.”
The company chose the forehead because it’s the only area widely validated for pulse oximetry that also causes a minimal level of discomfort or annoyance while sleeping.
According to Kisch, the company has plans to go further into the medical device realm with future versions of the product.
“By Q2 of next year we’ll be taking a path with the FDA to be approved as a home sleep test diagnostic,” Kisch said. “We’ll continue to have a very consumer-friendly product but we’re moving even deeper into the medical device territory. Because once we’re approved as a home sleep test diagnostic, we’ll be able to support a physician diagnosing a sleep disorder based upon the use of this data. So our plan over time is if you’re a person who has a sleep issue we want to help you not only understand your sleep problems, but provide a solution in under a week.”
What’s the trend
Digital health has seen many different sleep trackers over the years, and several high profile failed companies have been in this space, like Zeo and Hello. On the other hand, Beddit, a high profile sleep tracking company, was acquired by Apple.
In sleep apnea specifically, the big fish is ResMed, which has partnered with Alphabet subsidiary Verily to work on sleep apnea, as well as releasing its own connected CPAP devices. Australian company ResApp has developed a technology that can detect sleep apnea based purely on sound with 86 percent accuracy.
Kisch says Sleep Tuner’s goal is to find the perfect sweet spot between clinical and consumer sleep monitoring.CULTURE KINGS PARRAMATTA IS NOW HERE!