FDA OKs mHealth App, Platform for Detecting Traumatic Nightmares

By Eric Wicklund

November 10, 2020 - The US Food and Drug Administration has OK’d an innovative mHealth tool that can detect and help treat traumatic nightmares.

Called Nightware, the product consists of an mHealth app and corresponding smartphone platform that uses the Apple Watch to track motion and heart rate data during sleep. The platform creates a “sleep profile” for the user, which identifies normal sleep patterns; when the wearable detects symptoms consistent with a nightmare, it gently vibrates to rouse but not wake the user, interrupting the nightmare but allowing him or her to stay asleep.

Developed by a Minneapolis company of the same name, Nightware joins a growing list of telehealth and mHealth platforms aimed at the sleep market – and, further out, the mental health arena. Of particular interest are tools that help people living with PTSD, which can manifest itself in nightmares and sleep problems.

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“Sleep is an essential part of a person’s daily routine,” Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in the FDA press release. “However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need. Today’s authorization offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares.”

FDA officials were quick to point out that the digital therapeutic shouldn’t be used on its own, but should be prescribed as part of a care management plan that includes medications and therapy and under the supervision of a care provider.

Nightware was granted a Breakthrough Device designation through the FDA’s De Novo premarket review pathway following a 30-day trial involving some 70 participants. Those using the platform had better sleep patterns than a control group, allowing the FDA to conclude that the platform “demonstrated the probable benefits outweighed the probable risks.”

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FDA OKs mHealth App, Platform for Detecting Traumatic Nightmares

The mHealth app, used on an Apple Watch, identifies symptoms of a nightmare through movement and heart rate, then vibrates to interrupt the nightmare but not wake the user.

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