FDA Authorizes Digital Therapeutic for Sleep Disturbance in PTSD

NightWare is a smartwatch application that uses the Apple Watch and Apple iPhone platform.

The Food and Drug Administration has approved NightWare (NightWare, Inc.), a digital intervention therapy for the temporary reduction of sleep disturbance related to nightmares in adults aged 22 years or older who suffer from nightmare disorder or have nightmares from posttraumatic stress disorder (PTSD).

NightWare is a smartwatch application that uses the Apple Watch and Apple iPhone platform. The application is able to create a profile of a patient’s sleep patterns through integrated sensors and machine learning algorithms, typically after a learning period of less than 10 days. At the onset of a nightmare, the patient is aroused from sleep (without awakening) using vibrotactile feedback so that the nightmare is interrupted prior to the patient waking up in distress. The watch will not affect the circadian sleep pattern of the patient; if the application senses that the patient is being woken by the vibrations, it will vibrate less the next time.

The approval was based on data from a 30-day randomized sham-controlled trial involving 70 patients. Findings showed greater improvements on 2 versions of the Pittsburgh Sleep Quality Index scale (both the self-rated questionnaire for sleep quality and a version intended for PTSD patients) with NightWare compared with sham. Moreover, findings from the study showed no changes in either suicidality or sleepiness in either group, demonstrating that the probable benefits of NightWare outweigh the potential risks.

NightWare is not intended for use in patients who have been known to “act out” during their nightmares (eg, sleepwalking, violence). Moreover, the watch should not be used while reading or watching television in bed as this may trigger false alerts.

NightWare is available by prescription only and is intended for home use in conjunction with prescribed medications for PTSD and other recommended therapies. A desktop app, which displays the data collected by the smartwatch app, allows health care providers to review individual patient data.

For more information visit fda.gov.


FDA permits marketing of new device designed to reduce sleep disturbance related to nightmares in certain adults. [press release]. US Food and Drug Administration; November 6, 2020. 

This article originally appeared on MPR