The FDA has awarded De Novo certification to NigthWare which has developed a digital therapy to combat sleep disorders.
Nightmare disorder affects 5 million people and is classified as parasomnia, in the sense that it disturbs sleep, leads to dreams that are severe and frequent enough to have clinically significant effects in a person’s life. These recurring and sometimes prolonged nightmares are vivid and disturbing dreams that put the persons in a situation that endangers their life or personal safety. The frightening circumstances of nightmares often awaken the person to a state of full alert and can have a profound impact far beyond disturbed sleep.
The application uses the watch sensors to track people’s heart rate and movement while they sleep. After establishing a reference profile for the patient within one or two nights of sleep, the automatic learning algorithm detects heart rate or movement abnormalities caused by a nightmare. The application vibrates the smartwatch just enough to interrupt the wearer’s dream, but not enough to wake them up or interrupt their circadian sleep cycle. The patient can thus benefit from uninterrupted sleep.
Digital therapy is intended for domestic use among adults aged 22 years and over and requires a medical prescription. The FDA pointed out in the announcement that it is not a stand-alone therapy for PTSD and should be used in combination with other drugs and is also not intended for patients with a history of sleepwalking or violence during nightmares