Clinical Trial

Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

Study acronym: NDR/NW
Recruiting Phase 2
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Record status
This record was last updated March 30, 2025 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-05-02; most recent amendment 2025-03-25.
Status change: Not Yet Recruiting → Recruiting 2024-06-18
Trial Details
NCT Number NCT06399874
Lead Sponsor Uniformed Services University of the Health Sciences
Collaborators: NightWare
Conditions Nightmare
Enrollment 30 participants
Start Date 2024-06-11
Primary Completion 2025-10 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-03-30