0667 A digital prescription therapeutic device to treat nightmare disorders: A case series

Introduction: Nightmare disorder and post-traumatic stress disorder (PTSD)-associated nightmares can be treatment-resistant in many patients. There are no recommended treatments for these conditions currently.

Methods: NightWare is a novel FDA-approved class II medical device which improves sleep in patients with nightmare disorder and PTSD-associated nightmares. It uses data from a smart watch to determine when nightmares are happening using heart rate and movement sensors, and then intervenes to interrupt the nightmare and improve overall sleep quality. We report the 14 consecutive cases of patients using NightWare and the Clinical Global Impression (CGI) of Severity and Change in their sleep and reduction of nightmare burden.

Results: Of the 14 patients in this series, 10 patients used the device for more than 7 days. 1 discontinued due to perceived lack of efficacy, 2 stopped in part due to a skin rash, and one stopped because he did not want to wear a watch to sleep. At baseline, the 10 patients included in the analysis had a mean CGI Severity score of 4.7 (SD 1.25), which indicates moderate to severe nightmares and daytime dysfunction. Improvement in the CGI Change score with NightWare exceeded that of prazosin for this group of patients. The patients in this series that used the device had a mean score of 2.20 (SD 0.79) on the CGI Change scale, which indicates there was significant improvement from baseline. Six of the 10 patients using NightWare were also taking prazosin prior to starting NightWare. The prazosin dose ranged from 1-8 mg nightly for these patients. These 6 patients had minimal improvement with prazosin alone (CGIC of 3.16 (SD 0.41).

Conclusion: In this case series, NightWare significantly improved the symptoms of nightmare disorder in 10 of the 14 patients in this series. Patient selection for sympathetic nervous system activation is important to ensure the device’s effectiveness.