NCT06399874 Nightmare Deconstruction and Reprocessing vs. NightWare Wristband
| NCT ID | NCT06399874 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Uniformed Services University of the Health Sciences |
| Condition | Nightmare |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-06-11 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-06-11 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
James C West, MD
PRINCIPAL INVESTIGATOR
Uniformed Services University of the Health Sciences
Frequently Asked Questions
Who can join the NCT06399874 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 64 Years, studying Nightmare. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06399874 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06399874 currently recruiting?
Yes, NCT06399874 is actively recruiting participants. Contact the research team at patricia.spangler.ctr@usuhs.edu for enrollment information.
Where is the NCT06399874 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06399874 clinical trial?
NCT06399874 is sponsored by Uniformed Services University of the Health Sciences. The principal investigator is James C West, MD at Uniformed Services University of the Health Sciences. The trial plans to enroll 30 participants.