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Study for Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

This study is looking at two different ways to help people with nightmares, especially those related to trauma. One treatment is called Nightmare Deconstruction and Reprocessing (NDR), which is a type of talk therapy where you work with nightmare images. The other is a device called NightWare, a wristband that gently vibrates to help you sleep better if it senses a nightmare is starting. The study is for active duty service members and veterans between 22 and 64 years old who have at least one nightmare per week and some sleep problems. The researchers want to see how well these treatments work by tracking changes in your nightmares and sleep over about 18 weeks. The current status of the study is unclear, but it plans to enroll up to 30 participants.

Study design
This is a Phase IIa, single-blind, randomized controlled pilot study. It plans to enroll up to 30 service members and veterans.
What's involved
You would be assessed at the start, weekly for 12 weeks during treatment, and then at 3 follow-up visits up to 18 weeks after the study begins. There may also be early termination visits.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 18 weeks after the start of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06399874

Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

Recruiting
PHASE2Ages 22–64InterventionalTreatment
Uniformed Services University of the Health Sciences
~30 participants
Updated 2025-03-30 on ClinicalTrials.gov
What's tested:Nightmare Deconstruction and ReprocessingNightWare

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disturbing Dreams and Nightmare Severity Index
Measured over 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.
+1 more outcome measured

Conditions

Nightmare

Explore related trials

InsomniaPost-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • James C West, MD · PRINCIPAL_INVESTIGATOR · Uniformed Services University of the Health Sciences

Who to contact

Patricia Spangler, PhD
[email protected]
240-620-4076
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Disturbing Dreams and Nightmare Severity IndexIt 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.

    The DDNSI is a 5-item self-report instrument used to assess nightmare severity and distress both as an inclusion criterion (score ≥10) and as a primary study variable. Possible score range is 0-37, with a recommended cutoff of 10.

  • Insomnia Severity IndexIt 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.

    The ISI is a 7-item self-report measure that assesses not only perceived severity of insomnia with regards to difficulty falling and staying asleep, but also daytime dysfunction. Possible score range is 0-28, with a recommended cutoff of 8 for sub-threshold insomnia.