Actively Recruiting
Nightmare Deconstruction and Reprocessing vs. NightWare Wristband
Led by Uniformed Services University of the Health Sciences · Updated on 2025-03-30
30
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
Sponsors
U
Uniformed Services University of the Health Sciences
Lead Sponsor
N
NightWare
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nightmare Deconstruction and Reprocessing vs. NightWare Wristband
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Active duty service members and veterans
- At least 1 nightmare per week for the past month
- Insomnia Severity Index score of 8 or higher
- Stable dose of medications for PTSD, depression, anxiety, or insomnia for at least 8 weeks if taking any
You will not qualify if you...
- Serious risk of suicide
- Psychosis, bipolar disorder, or alcohol or substance use disorder
- Untreated moderate to severe sleep apnea
- Use of synthetic glucocorticoid beta blockers, prazosin, or varenicline
- Currently receiving psychotherapy directly targeting nightmares, insomnia, or PTSD
- Inability to recall nightmare content
- Inability to wear or sync wristband data
- Inability to comply with blood draws
- Refusal to consent to DNA analysis of blood samples
- Refusal to consent to audio recording of study visits
- REM sleep behavior disorder or narcolepsy as determined by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Uniformed Services University of the Health Sciences
Bethesda, Maryland, United States, 20814
Actively Recruiting
Research Team
P
Patricia Spangler, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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