FDA grants breakthrough designation for NightWare app

23 May 2019 (Last Updated May 23rd, 2019 11:57)

Digital therapeutics startup NightWare has secured breakthrough designation from the US Food and Drug Administration (FDA) for its smart watch app meant to help patients with nightmare disorder.

Digital therapeutics startup NightWare has secured breakthrough designation from the US Food and Drug Administration (FDA) for its smart watch app meant to help patients with nightmare disorder.

The NightWare app is designed to measure and treat nightmares in people suffering from post-traumatic stress disorder (PTSD).

It runs on the Apple Watch platform and captures biometric data via integrated sensors. The watch monitors heart rate while sleeping, and a gyroscope and accelerometer track movement.

The wearable technology learns sleep patterns and uses machine learning algorithms to generate a profile of a person’s patterns.

Upon detecting the onset of a nightmare, the device sends vibrotactile feedback to arouse the user out of sleep without actually waking them.

The app uses a formula to customise treatment for each individual. It begins with a low-intensity intervention, and if the desired result is not obtained, the app increases the intensity.

According to the company, the approach interrupts the nightmare without affecting the circadian sleep pattern and thus allowing better sleep for the patient.

NightWare CEO and founder Grady Hannah said: “In our initial studies, NightWare has demonstrated substantial and significant efficacy.

“In our initial studies, NightWare has demonstrated substantial and significant efficacy.”

“The FDA’s breakthrough status designation will enable us to complete our randomised 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.”

Currently, the company is recruiting patients into two randomised clinical trials (RCTs). One of the studies is being conducted at VA hospitals at Minneapolis and St Cloud, Minnesota in the US.

In addition, NightWare is enrolling for a virtual RCT trial with broader geographic scope.