A randomized sham-controlled clinical trial of a novel wearable intervention for trauma-related nightmares in military veterans

STUDY OBJECTIVES: Persistent nightmares are common among individuals exposed to trauma and are especially prevalent among veterans. While behavioral and pharmacological interventions are available, they have demonstrated limited efficacy. Innovations in wearable technology provide a potential avenue to match or exceed these existing treatments by directly targeting nightmare physiology. METHODS: We conducted a randomized, sham-controlled study to determine the efficacy of a novel wearable device-based application in 65 veterans with impaired sleep secondary to trauma-related nightmares. Changes in measures of sleep quality, posttraumatic stress disorder/depression symptoms, and quality of life across the 30-day trial were compared between the Active and Sham systems. RESULTS: Both groups demonstrated statistically significant within-person improvement on all measures. While the Active system was generally associated with stronger magnitude of improvement, none of the comparisons of individual measures across conditions reached statistical significance. However, a post-hoc analysis excluding participants with low frequency of usage demonstrated significantly better improvement in perceived sleep quality with the Active device than Sham. CONCLUSIONS: Overall, these results provide preliminary evidence that a wearable device may improve self-reported sleep quality for veterans reporting frequent trauma-related nightmares, especially in compliant users. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken) (TNT/NW); URL: https://www.clinicaltrials.gov/ct2/show/NCT04040387; Identifier: NCT04040387. CITATION: Davenport ND, Werner JK. A randomized sham-controlled clinical trial of a novel wearable intervention for trauma-related nightmares in military veterans. J Clin Sleep Med. 2023;19(2):361-369.