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

Nicholas D. Davenport, Kent J. Werner

Research output: Contribution to journalArticlepeer-review

5 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)361-369
Number of pages9
JournalJournal of Clinical Sleep Medicine
Issue number2
StatePublished - Feb 1 2023

Bibliographical note

Funding Information:
All authors have seen and approved the manuscript. All work was performed at the Minneapolis VA Medical Center, Minneapolis, MN. The research reported here was supported with funds provided by NightWare, Inc. This company did not participate in the analysis or reporting of results, and neither author has received direct compensation from NightWare. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the Uniformed Services University, US Government, Department of Defense, or the US Department of Veterans Affairs, and no official endorsement should be inferred. The authors report no conflicts of interest.

Publisher Copyright:
© 2023 American Academy of Sleep Medicine. All rights reserved.


  • nightmares
  • post-traumatic stress disorder
  • sleep quality
  • trauma
  • veterans

PubMed: MeSH publication types

  • Randomized Controlled Trial
  • Journal Article
  • Research Support, Non-U.S. Gov't


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