Nightware gets FDA approval for studies of PTSD-related app
Star TribuneMay 22, 2019
NightWare also is launching two clinical trials for its digital intervention, one of which is being conducted within
“We’re FDA regulated but because this is a low-risk treatment, digital-therapeutic, we are enrolling for a virtual clinical trial and anyone in
Hannah said Nightware has been running on about
“[Breakthrough status] is a really nice thing from our perspective because we have, internally, had a lot of discussions around the reasons why we thought this was a significant and important advance in medical technology,” Dr.
NightWare’s product is an app for the Apple Watch that uses the device’s biometric sensors to monitor the sleeping wearer’s heart rate and movement, he said. Within just a night or two of sleep, the app’s machine learning component is trained to detect when the wearer is distressed by a nightmare. At this point the smartwatch vibrates to interrupt the wearer’s dreaming, but not enough to wake them up or disrupt their circadian sleep pattern.
“We’re … asking questions about nightmares and obviously we help to reduce nightmares, but the endpoint we’re actually looking at is sleep quality,” Karlin told MobiHealthNews. “If we’re waking someone up too much, we’re not going to make them better. The goal is not just to reduce nightmare, but to improve sleep.”
NightWare has been conducting trials of the app with the
Should the therapy prove effective among this population, Karlin and Hannah noted that these hands-on trials with the
Hannah, 46, is a
Investment banker
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