A Drug-Free Treatment for PTSD With an App? FDA Gives Nightwatch Breakthrough Designation for Non-Drug Treatment
A game-changer for treating PTSD?
Minneapolis-based NightWare, developer of a “smartwatch therapeutic” for those with PTSD-driven traumatic nightmares, has received “breakthrough therapy designation” from the U.S. Food and Drug Administration for its development-stage application.
NightWare also is launching two clinical trials for its digital intervention, one of which is being conducted within Department of Veterans Affairs hospitals.
“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 the United States can enroll [at nightware.com],” CEO Grady Hannah said Wednesday.
Hannah said Nightware has been running on several-hundred thousand in invested capital since 2017 and that the app was invented by a computer science graduate student in 2016.
“[Breakthrough status] is a really nice thing…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. Daniel Karlin, chief medical officer at NightWare, told MobiHealthNews. “We’re engaged with the agency in trying to generate a body of evidence that doesn’t just show efficacy, but shows efficacy versus sham, versus placebo … and we’re doing it quickly because among veterans with PTSD, there’s a suicide per hour. We believe that this may reduce suicide, so we have an obligation to get this to folks as fast as we can.”
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.
‘tis a shame they didn’t include Samsung’s Gear/Galaxy Watches….