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Behavioral Intervention

NDR vs. NightWare Wristband for Trauma-Related Nightmares (NDR/NW Trial)

Phase 2
Recruiting
Led By James C West, MD
Research Sponsored by Uniformed Services University of the Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Minimum symptom severity: Has had at least 1 nightmare per week for the past month
Be between 18 and 65 years old
Must not have
Untreated moderate to severe sleep apnea
Use of synthetic glucocorticoid beta blockers, prazosin, or varenicline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study two new treatments for post-trauma nightmares. One treatment is a therapy called Nightmare Deconstruction and Reprocessing (NDR), while the other involves using a wristband device called

Who is the study for?
This trial is for active duty service members and veterans who've had at least one nightmare per week in the past month due to PTSD. They must have a certain level of sleep disturbance, measured by an ISI score of 8 or more, and if they're taking meds for PTSD, depression, anxiety, or insomnia, doses must be stable for 8 weeks.
What is being tested?
The study compares two treatments: Nightmare Deconstruction and Reprocessing (NDR), which is a type of talk therapy facing the nightmares; and NightWare (NW), using a wristband that doesn't involve talking about the nightmares. It also tests new ways to measure treatment effects like blood sampling tied to body clocks.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from discussing traumatic events during NDR therapy or skin irritation/sleep disturbances from wearing the NW wristband.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have experienced at least one nightmare every week for the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have moderate to severe sleep apnea that hasn't been treated.
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I am currently taking synthetic glucocorticoids, beta blockers, prazosin, or varenicline.
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I cannot wear or sync data from a wristband.
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I refuse to allow my blood samples to be used for DNA analysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disturbing Dreams and Nightmare Severity Index
Insomnia Severity Index
Secondary study objectives
Operational Stress Index (OSI)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Nightmare Deconstruction and ReprocessingExperimental Treatment1 Intervention
Psychotherapy that uses exposure to nightmare images for trauma activation with the goal of memory reconsolidation.
Group II: NightWareExperimental Treatment1 Intervention
Wristband device that detects physiologic signals during sleep that indicate a possible nightmare and gently vibrates to rouse the sleeper without fully waking them.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NightWare
2022
N/A
~40

Find a Location

Who is running the clinical trial?

Uniformed Services University of the Health SciencesLead Sponsor
123 Previous Clinical Trials
90,629 Total Patients Enrolled
NightWareIndustry Sponsor
4 Previous Clinical Trials
766 Total Patients Enrolled
4 Trials studying Nightmares
766 Patients Enrolled for Nightmares
James C West, MDPrincipal InvestigatorUniformed Services University of the Health Sciences
~20 spots leftby Oct 2025
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