Comparing two treatments for post-trauma nightmares
Pilot Trial Comparing Exposure and Nonexposure Treatments for Posttrauma Nightmares and Insomnia: Nightmare Deconstruction and Reprocessing vs. NightWare Wristband
This study is testing two different treatments for nightmares after trauma to see which one helps servicemembers and veterans feel better while they sleep.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 22 Years to 64 Years |
| Sex | All |
| Sponsor | Uniformed Services University of the Health Sciences Federal |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06399874 on ClinicalTrials.gov |
What this trial studies
This Phase IIa pilot trial evaluates the efficacy of two treatments for post-traumatic nightmares: Nightmare Deconstruction and Reprocessing (NDR), an exposure-based psychotherapy, and NightWare (NW), a wristband device that detects physiological signals of nightmares and gently rouses the sleeper. The study aims to assess participant tolerance and compliance with both treatments while collecting physiological data and biomarker samples to better understand the impact of these interventions. The trial will involve up to 30 servicemembers and veterans over an 18-week period, including 6 weeks of observation and 6 weeks of active treatment.
Who should consider this trial
Good fit: Ideal candidates include active duty servicemembers and veterans experiencing at least one nightmare per week and meeting specific symptom severity criteria.
Not a fit: Patients with serious mental health conditions, such as psychosis or severe sleep disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-pharmacologic treatments for individuals suffering from post-traumatic nightmares.
How similar studies have performed: While there have been preliminary studies on these treatments, this trial represents a novel approach to assessing their efficacy in a controlled setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Active duty service members and veterans * Minimum symptom severity: * Has had at least 1 nightmare per week for the past month * Has a minimum ISI score of 8 * If taking medications for PTSD, depression, anxiety, or insomnia, must be on stable dose for 8 weeks. Exclusion Criteria: * 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 * Current evidence-based or experimental psychotherapy directly targeting nightmares, insomnia, or PTSD * Inability to recall nightmare content * Inability to wear wristband 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
Where this trial is running
Bethesda, Maryland
- Uniformed Services University of the Health Sciences — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: James C West, MD — Uniformed Services University of the Health Sciences
- Study coordinator: Patricia Spangler, PhD
- Email: patricia.spangler.ctr@usuhs.edu
- Phone: 240-620-4076
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.