Evidence map›Paper›PMID 36305584›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2023

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

Nicholas D Davenport, J Kent Werner

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04040387 nacompletednot on this map

TNT/NW: Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)

TypeinterventionalSponsorNightWareRan2019 to 2025Enrolled270ConditionsStress Disorders, Post-Traumatic, Combat Disorders, Ptsd, NightmareArmsNightWare Therapeutic System, Sham NightWare
NCT07288593 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention in the warfiGHTer (INSIGHT)

TypeinterventionalSponsorUniformed Services University of the Health SciencesRan2026 to 2027Enrolled180ConditionsNightmare, Insomnia, PTSD, TBIArmsNightWare smartwatch configured to detect physiological signs of sympathetic activation during sleep, such as heart-rate spikes and movement patterns., Sham (No Treatment)
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Review
  9. Observational
  10. Review
  11. Emerging and upcoming therapies in insomnia.Translational and clinical pharmacology · 2024
    Article
  12. Review
  13. Digital therapeutics in the clinic.Bioengineering & translational medicine · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors at 2 institutions in 1 country.

Nicholas D DavenportResearch, Minneapolis VA Health Care System, Minneapolis, Minnesota.
J Kent WernerCenter for Neuroscience and Regenerative Medicine, Uniformed Services University, Bethesda, Maryland.
Uniformed Services University of the Health Sciences · USUniversity of Minnesota · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesPersistent 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.

methodsWe 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.

resultsBoth 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.

conclusionsOverall, 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 registrationRegistry: 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.

Indexed as

Stress Disorders, Post-TraumaticVeteransDreamsHumansQuality of LifeSleepnightmarespost-traumatic stress disordersleep qualitytraumaveterans

Identifiers

PMID36305584
PMCPMC9892731
OpenAlexW4307479772

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.