Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

NCT06399874 | Recruiting Phase 2 FDA Device

• 1 other identifier: PSY-88-13264
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Disturbing Dreams and Nightmare Severity Index

  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.

  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

  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.

  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.

Secondary Outcomes (4)

• Operational Stress Index (OSI)

  Collected from baseline through study completion (up to 18 weeks).

• Brain-derived neurotrophic factor (BDNF) levels before and after exposure

  Collected at initial NDR exposure component (6 weeks after baseline) and NDR final exposure (12 weeks after baseline).

• Cortisol levels before and after exposure

  Collected at initial NDR exposure component (6 weeks after baseline) and NDR final exposure (12 weeks after baseline).

• Adrenocorticotropic hormone (ACTH) levels before and after exposure

  Collected at initial NDR exposure component (6 weeks after baseline) and NDR final exposure (12 weeks after baseline).

Study Arms (2)

Nightmare Deconstruction and Reprocessing

EXPERIMENTAL

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

Behavioral: Nightmare Deconstruction and Reprocessing

NightWare

EXPERIMENTAL

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

Device: NightWare

Interventions

Nightmare Deconstruction and Reprocessing BEHAVIORAL

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

Also known as: NDR

Nightmare Deconstruction and Reprocessing

NightWare DEVICE

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

Also known as: NW

NightWare

Eligibility Criteria

• Age: 22 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• NightWare: collaborator

Study Sites (1)

Uniformed Services University of the Health Sciences

Bethesda, Maryland, 20814, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• James C West, MD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Spangler, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Phase IIa, two-arm, block randomized controlled pilot trial

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: May 6, 2024
• Study Start: June 11, 2024
• Primary Completion: October 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)