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Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

Study acronym: NDR/NW
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later Oct 2025 → Dec 2026
See other at-risk trials from Uniformed Services University of the Health Sciences

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Oct 2025 to Dec 2026 Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion pushed from Mar 2026 to Dec 2026
    • Eligibility criteria expanded, about 16 words
    • Site details revised
  2. Study description expanded, about 19 words
    • Study title shortened, about 3 words
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2024 to Jun 11, 2024
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The overall goal of this Phase IIa randomized controlled pilot trial is to assess the potential efficacy of two emerging treatments for post-trauma nightmares and to test the feasibility of study design and methods. Symptom change will be assessed in two treatment arms: (1) Nightmare Deconstruction and Reprocessing (NDR), an exposure-based psychotherapy; and (2) NightWare (NW), a non-exposure approach using a wristband device. The investigators will also assess the feasibility of circadian-dependent blood sampling and use of another wristband to collect physiologic data. Specific aims are: (1) Compare evidence of how well participants tolerate and comply with the two treatments and test feasibility of methods and procedures; (2) Collect additional evidence of the potential efficacy of two contrasting non-pharmacologic approaches to treating posttraumatic nightmares; (3) Explore the operational stress index (OSI) as a reliable, objective measure of sleep disturbance and nightmare events.
Trial Details
NCT Number NCT06399874
Lead Sponsor Uniformed Services University of the Health Sciences
Collaborators: NightWare
Conditions
(from sponsor)		 Nightmare
Related terms Sleep Initiation and Maintenance Disorders, Stress Disorders, Post-Traumatic
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov