Recruiting
Phase 2

Nightmare Deconstruction & NightWare

Sponsor:

Uniformed Services University of the Health Sciences

Code:

NCT06399874

Conditions

Nightmare

Eligibility Criteria

Sex: All

Age: 22 - 64

Healthy Volunteers: Not accepted

Interventions

Nightmare Deconstruction and Reprocessing

NightWare

Study Details

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.

Conditions

Nightmare

Study ID

NCT06399874

Start date

Jun 11, 2024

Status verified date

Mar, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 64

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nightmare Deconstruction and Reprocessing

Psychotherapy that uses exposure to nightmare images for trauma activation with the goal of memory reconsolidation.

experimental: NightWare

Wristband device that detects physiologic signals during sleep that indicate a possible nightmare and gently vibrates to rouse the sleeper without fully waking them.

Interventions

Nightmare Deconstruction and Reprocessing

A psychotherapy that uses exposure to nightmare images for trauma activation in order to facilitate trauma memory reconsolidation

NightWare

Wristband device that detects physiologic signals during sleep that indicate a possible nightmare and gently vibrates to rouse the sleeper without fully waking them.

Primary outcome measure

  • Disturbing Dreams and Nightmare Severity Index [ Time Frame: 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. ]
  • Insomnia Severity Index [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Patricia Spangler, PhD

240-620-4076patricia.spangler.ctr@usuhs.edu

Locations

Uniformed Services University of the Health Sciences

Recruiting

Bethesda, Maryland, United States, 20814

Contacts

James C West, MD

301-319-4281james.west@usuhs.edu

Patricia Spangler, PhD

240-620-4076patricia.spangler.ctr@usuhs.edu

Principal Investigator:

James C West, MD

More Information

Sponsor

Uniformed Services University of the Health Sciences

Last update posted

Mar 30, 2025

Last verified

Mar, 2025

Keywords

  • Nightmares
  • Insomnia
  • PTSD
  • Heart Rate Variability
  • Electrodermal Activity
  • BDNF
  • Cortisol
  • ACTH
  • Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Uniformed Services University of the Health Sciences on 2025-03-30.