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A new prescription smartwatch app may improve sleep quality for those with nightmare disorders.
The US Food and Drug Administration (FDA) granted a De Novo clearance to a prescription Apple watch and iPhone app meant to improve sleep quality for those with nightmare disorders or posttraumatic stress disorder-related nightmares.
NightWare’s digital therapeutic1 uses the watch’s sensors to track the user’s heart rate and movement as they sleep. A baseline profile is created for the patient within 1 to 2 nights of sleep. In this short time frame, the learning algorithm will spot heart rate of movement abnormalities likely caused by a nightmare. If the app senses a disturbance, the Apple watch will vibrate enough to interrupt the dream, but not enough to fully wake them up and disturb their sleep cycle.
“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 to the press. “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.”2
Data submitted to the FDA included information from a 30-day trial of 70 patients who were randomly assigned to receive either the NightWare app or a placebo app with no vibrations. While both groups self-reported improved sleep quality, the benefit was greater for those provided with the Nightware product.
Further trials are being conducted, one of which hopes to include 240 patients from several Department of Veterans Affairs hospitals. It is projected to finish in the second half of 2021.
“NightWare was founded and built to support veterans and active duty service members who have so unselfishly given of themselves to preserve our freedoms, and suffer emotional, physical and mental distress as a consequence of severe nightmares,” NightWare CEO Grady Hannah said in a statement. “Helping our current and past military members and all people with this condition is NightWare’s mission and we are excited to introduce this first and only therapeutic for nightmares. The use of the NightWare Therapeutic Platform provides an effective treatment for clinically significant nightmares; avoids drug side-effects; and reduces the need for time intensive and often-unavailable psychological therapy sessions.”2
The NightWare therapy is currently available on a limited basis through physician recommendation, but will hopefully launch in the early months of 2021. It will require a prescription and is intended for use among adults aged 22 years or older. It is not recommended for patients who sleepwalk or have violent episodes during nightmares. It is also not recommended as a standalone treatment for PTSD.
1. NightWare. We won’t rest until those with PTSD can. Accessed November 13, 2020. https://night-ware.com
2. Muoio D. FDA grants De Novo clearance to prescription Apple Watch app for nightmare disorder. Mobi Health News. November 9, 2020. https://www.mobihealthnews.com/news/fda-grants-de-novo-clearance-prescription-apple-watch-app-nightmare-disorder