NDR vs. NightWare Wristband for Trauma-Related Nightmares

(NDR/NW Trial)

Overseen By Patricia Spangler, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Uniformed Services University of the Health Sciences

Must not be taking: Beta blockers, Prazosin, Varenicline

Disqualifiers: Psychosis, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two new methods to help people manage trauma-induced nightmares. One method, Nightmare Deconstruction and Reprocessing (NDR), involves confronting nightmare images to alter memory storage. The other method uses a NightWare wristband that detects potential nightmares and gently vibrates to interrupt them without fully waking the person. Suitable participants include active duty service members or veterans who experience at least one nightmare per week and maintain a stable medication dose for PTSD, depression, anxiety, or insomnia. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking therapy development.

Will I have to stop taking my current medications?

The trial requires that if you are taking medications for PTSD, depression, anxiety, or insomnia, you must be on a stable dose for 8 weeks before participating. You cannot use synthetic glucocorticoid beta blockers, prazosin, or varenicline.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found the NightWare wristband safe for people with trauma-related nightmares. This device detects nightmares and gently vibrates to help without fully waking the person. However, NightWare is not recommended for those who have acted out their nightmares, such as sleepwalking or exhibiting violent behavior.

Nightmare Deconstruction and Reprocessing (NDR) is a newer therapy. It helps individuals face their nightmares in a safe setting to reduce their impact. Although detailed safety information is not yet available, researchers are testing NDR to evaluate its effectiveness and how people respond to it.

Both treatments are under study for effectiveness and safety, with NightWare already supported by some safety data. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for trauma-related nightmares because they offer unique approaches compared to traditional options like medication and talk therapy. Nightmare Deconstruction and Reprocessing (NDR) uses a specialized form of psychotherapy that exposes patients to their nightmare images directly, aiming for memory reconsolidation, which could lead to more lasting relief from distressing dreams. On the other hand, the NightWare wristband represents a novel delivery method, as it detects physiological signals of nightmares and gently vibrates to interrupt them without waking the sleeper fully, potentially improving sleep quality with minimal disruption. These innovative methods offer promising alternatives to existing treatments, which often involve medications with side effects or therapies that may take longer to show results.

What evidence suggests that this trial's treatments could be effective for post-trauma nightmares?

This trial will compare two treatments for trauma-related nightmares: Nightmare Deconstruction and Reprocessing (NDR) and the NightWare wristband. Studies have shown that NDR can reduce the intensity of nightmares and improve sleep for individuals with trauma-related nightmares. Research indicates that after treatment, individuals experience better sleep and fewer nightmares. The NightWare wristband, another treatment option in this trial, enhances sleep by detecting nightmares and gently waking the user without fully waking them. This device has shown promise in assisting veterans with trauma-related nightmares. Both treatments show early signs of effectiveness in reducing nightmares, but further research is needed to confirm these findings. ^{4 5 6 7 8}

Who Is on the Research Team?

James C West, MD

Principal Investigator

Uniformed Services University of the Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Active duty service members and veterans

Minimum ISI score of 8

I have experienced at least one nightmare every week for the last month.

Exclusion Criteria

Serious risk of suicide

Psychosis, bipolar disorder, or alcohol or substance use disorder

Inability to recall nightmare content

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either Nightmare Deconstruction and Reprocessing (NDR) or NightWare (NW) treatment. NDR involves exposure-based psychotherapy, while NW uses a wristband device to detect and respond to nightmares.

12 weeks

4 visits (in-person), 12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of insomnia and nightmare severity.

6 weeks

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Nightmare Deconstruction and Reprocessing
• NightWare

Trial Overview

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.

How Is the Trial Designed?

Group I: Nightmare Deconstruction and Reprocessing Experimental Treatment 1 Intervention

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

Group II: NightWare Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Uniformed Services University of the Health Sciences

Lead Sponsor

Trials

130

Recruited

91,100+

NightWare

Industry Sponsor

Trials

5

Recruited

800+

Published Research Related to This Trial

In a case series of four young male U.S. Army Soldiers, disruptive nocturnal behaviors (DNB) and trauma-related nightmares were linked to REM sleep without atonia, indicating a specific sleep disturbance pattern following trauma.

Treatment with prazosin was effective in improving both DNB and nightmares in all patients, suggesting it may be a beneficial intervention for those experiencing trauma-associated sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma associated sleep disorder: a proposed parasomnia encompassing disruptive nocturnal behaviors, nightmares, and REM without atonia in trauma survivors. Mysliwiec, V., O'Reilly, B., Polchinski, J., et al.[2022]

In a study involving 104 participants, imagery rescripting (IR) was found to improve nightmare symptoms by enhancing the individual's mastery over the nightmare content, indicating a mechanism of increased self-efficacy.

Imaginal exposure (IE) also effectively reduced nightmares, but its therapeutic effects were linked to helping individuals better tolerate the negative emotions associated with their nightmares, suggesting that IR and IE operate through different psychological processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediators of Change in Imagery Rescripting and Imaginal Exposure for Nightmares: Evidence From a Randomized Wait-List Controlled Trial. Kunze, AE., Lancee, J., Morina, N., et al.[2019]

A study involving 92 participants over 22 days found that the Nightmare Distress Questionnaire (NDQ) effectively measures 'general nightmare distress' and 'impact on sleep', but its subscale for 'impact on daily reality perception' lacks clear validity.

The NDQ does not distinguish between nightmares and bad dreams, suggesting it may measure negative dreams in general rather than specifically assessing nightmare distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validating Psychometric Questionnaires Using Experience-Sampling Data: The Case of Nightmare Distress. Stieger, S., Kuhlmann, T.[2020]

In a study involving 36 patients with nightmare disorder, targeted memory reactivation (TMR) during REM sleep significantly reduced the frequency of nightmares and improved dream emotions compared to a control group after 2 weeks of imagery rehearsal therapy (IRT).

The TMR technique not only enhanced the effectiveness of IRT but also led to a sustained decrease in nightmares over a 3-month period, suggesting its potential for broader applications in treating other psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing imagery rehearsal therapy for nightmares with targeted memory reactivation. Schwartz, S., Clerget, A., Perogamvros, L.[2023]

In a randomized controlled trial with 104 patients suffering from nightmare disorder, both imagery rescripting (IR) and imaginal exposure (IE) significantly reduced nightmare frequency and distress compared to a wait-list control group.

The positive effects of both treatments were not only immediate but also sustained over 3- and 6-month follow-ups, suggesting that IR and IE are effective components of cognitive-behavioral therapies for nightmares.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of imagery rescripting and imaginal exposure for nightmares: A randomized wait-list controlled trial. Kunze, AE., Arntz, A., Morina, N., et al.[2019]

The dream reorganization approach, which combines systematic desensitization and guided rehearsal, effectively reduced recurrent nightmares in a 10-year-old boy, leading to a complete elimination of nightmares and nighttime disturbances.

This treatment method is based on established theories of dream construction and offers a promising new direction for addressing nightmares, highlighting the potential for cognitive-behavioral strategies in improving sleep-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of recurrent nightmares by the dream reorganization approach. Palace, EM., Johnston, C.[2019]

Nightmares affect 4%-10% of the population weekly and are linked to factors like gender, age, stress, and mental health issues, but their exact causes remain unclear.

The authors propose a new framework suggesting that variations in nightmares are influenced by daily emotional pressures and individual emotional reactivity, integrating insights from cognitive neuroscience and emotional memory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disturbed dreaming, posttraumatic stress disorder, and affect distress: a review and neurocognitive model. Levin, R., Nielsen, TA.[2022]

Chronic nightmares affect a significant number of trauma survivors and about 5% to 8% of the general population, indicating that they may be a primary sleep disorder rather than just a symptom of other psychiatric issues.

Imagery Rehearsal Therapy (IRT) is the most supported treatment for nightmares, involving four 2-hour sessions that focus on cognitive-imagery techniques, with suggestions for dismantling protocols to tailor the therapy to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical management of chronic nightmares: imagery rehearsal therapy. Krakow, B., Zadra, A.[2019]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36305584/

A randomized sham-controlled clinical trial of a novel ...

Conclusions: Overall, these results provide preliminary evidence that a wearable device may improve self-reported sleep quality for veterans ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9892731/

A randomized sham-controlled clinical trial of a novel ...

Overall, these results provide preliminary evidence that a wearable device may improve self-reported sleep quality for veterans reporting frequent trauma- ...

3.

nightware.com

nightware.com/professionals/

Professionals

... trauma-related nightmares are effectively targeted by the NightWare device. ... nightmares impact recovery and treatment outcomes and worsens PTSD symptoms.

4.

trialx.com

trialx.com/clinical-trials/listings/293346/pilot-trial-comparing-nightmare-deconstruction-and-reprocessing-vs-nightware-wristband/

Pilot Trial Comparing Nightmare Deconstruction and ...

We anticipate results that participants in both treatment groups will have a clinically significant decrease in nightmares and nightmare- ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04040387

Traumatic Nightmares Treated by NightWare (To Arouse ...

This study will provide preliminary estimates of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary ...

6.

nightware.com

nightware.com/wp-content/uploads/2021/08/NIGHTWARE-CLINICAL-DATA-OVERVIEW.pdf

NIGHTWARE CLINICAL INFORMATION

Safety data from this trial shows that NightWare is safe to use. Thus far ... trauma-related nightmares are effectively targeted by the NightWare device.

7.

nightware.com

nightware.com/important-safety-information/

Important Safety Information

CONTRAINDICATIONS. If you have acted out your nightmares (i.e. sleepwalking, violence) do not use NightWare and contact your Healthcare Provider. WARNINGS.

8.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/reviews/DEN200033.pdf

DEN200033 Decision Summary - accessdata.fda.gov

The NightWare device is not intended to be used as a standalone therapy for PTSD and should be used in conjunction with a patient's prescribed medications and ...