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NightWare Receives Breakthrough Designation for PTSD Nightmare App


The Apple Watch app uses biometric data and sensors to interrupt a nightmare without waking the patient.


NightWare’s namesake mental health digital therapeutic has received breakthrough status designation from the U.S. Food and Drug Administration (FDA), according to the company.

The product measures and treats nightmares in individuals with post-traumatic stress disorder (PTSD). Nightmares and nightmare disorder are linked to increased suicidality, risk of heart disease and diabetes and contribute to memory loss, anxiety, depression and other physical and mental conditions.

NightWare is an application that runs on the Apple Watch. The smartwatch collects biometric data through sensors and uses machine-learning algorithms to create a profile of a person’s sleep patterns.

When the program detects the onset of a nightmare, the device vibrates to interrupt the nightmare. The app doesn’t interfere with the circadian sleep pattern, which NightWare claims prevents the patient from waking.

The FDA designation recognizes NightWare as a therapeutic solution for a life-threatening condition with no other approved treatments. With the designation, the agency can grant priority review when clinical trials show that the solution offers substantial treatment advantages over existing therapies for patients with serious or life-threatening diseases.

Grady Hannah, CEO and founder of NightWare, said the product showed significant efficacy in initial studies.

The company is enrolling patients in two randomized clinical trials, including one that’s being conducted at a U.S. Department of Veterans Affairs hospitals in Minnesota. The company is also conducting a virtual trial with a broader scope.

“The FDA’s breakthrough status designation will enable us to complete our randomized clinical trials ahead of schedule and give us the opportunity to help improve the lives of veterans and others suffering from PTSD sooner than we anticipated,” Hannah said.

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