Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Uniformed Services University of the Health Sciences
Study ID
NCT06399874
Phase
PHASE2
Status
Recruiting
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Conditions

  • Nightmare

Eligibility Criteria

Sex
ALL
Age
22 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Nightmare Deconstruction and Reprocessing — BEHAVIORAL
    A psychotherapy that uses exposure to nightmare images for trauma activation in order to facilitate trauma memory reconsolidation
  • NightWare — DEVICE
    Wristband device that detects physiologic signals during sleep that indicate a possible nightmare and gently vibrates to rouse the sleeper without fully waking them.

Study Details

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.

Key Dates

Start date
Jun 11, 2024
Status verified
Mar 2025
Primary completion
Oct 31, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nightmare Deconstruction and Reprocessing
    Psychotherapy that uses exposure to nightmare images for trauma activation with the goal of memory reconsolidation.
  • Experimental: NightWare
    Wristband device that detects physiologic signals during sleep that indicate a possible nightmare and gently vibrates to rouse the sleeper without fully waking them.

Primary Outcome Measure

Disturbing Dreams and Nightmare Severity Index [ Time Frame: It will be completed at screening, weekly through the observation and treatment periods (12 weeks), and at the 3 follow-up visits (up to 18 weeks post-baseline). It will also be completed at early termination visits, if applicable. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Uniformed Services University of the Health SciencesBethesdaMaryland20814
James C West, MD
[email protected]
301-319-4281
Patricia Spangler, PhD
[email protected]
240-620-4076
James C West, MD (PRINCIPAL_INVESTIGATOR)
Patricia Spangler, PhD (SUB_INVESTIGATOR)

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By research site
Uniformed Services University of the Health Sciences· Bethesda, MD

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