NightWare for PTSD

Overseen By Claire Cox, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Insulin, Sulfonylureas

Disqualifiers: Unstable medical condition, Pregnancy, Substance abuse, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a wrist-wearable device called NightWare to determine if it can help veterans with PTSD sleep better and improve heart health. The study compares two groups: one using the active NightWare device and another using a non-active version. Veterans diagnosed with PTSD, who experience frequent nightmares that disrupt sleep and have poor overall sleep quality, may be suitable candidates.

As an unphased trial, this study provides veterans the opportunity to explore a novel approach to enhancing sleep quality and heart health.

Do I need to stop my current medications for the NightWare for PTSD trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using insulin or sulfonylureas, you cannot participate in the trial.

What prior data suggests that the NightWare device is safe for improving sleep in Veterans with PTSD?

Research has shown that NightWare, a digital therapy system, is generally safe for users. One study found no major differences in safety measures, such as daytime sleepiness, between those using NightWare and those who were not, suggesting that NightWare does not affect daytime alertness.

Other studies have also examined NightWare's safety and found it carries low risks. With no FDA-approved treatments specifically for nightmare disorders, NightWare's safety appears promising for individuals considering it for PTSD-related nightmares. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about NightWare for PTSD because it offers a novel, tech-driven approach to managing nightmares, a common symptom of PTSD. Unlike traditional treatments like therapy or medication, NightWare uses a therapeutic system centered around a smartwatch and app that detects and intervenes during nightmares without waking the user. This non-invasive, personalized intervention could provide relief more quickly and with fewer side effects than medications, offering a fresh alternative for those who struggle with PTSD-related sleep disturbances.

What evidence suggests that the NightWare device is effective for improving sleep in Veterans with PTSD?

Research shows that NightWare, a prescription device worn during sleep, might help veterans with PTSD-related nightmares. In this trial, participants will join either the NightWare active arm, using the NightWare Therapeutic System, or the NightWare sham arm, where the device will not deliver an intervention. A study found that veterans using NightWare reported better sleep than those using a sham device. This suggests NightWare might reduce the frequency and intensity of nightmares, leading to improved sleep overall. By enhancing sleep quality, NightWare could also positively impact mental and physical health. These early results offer hope for those facing sleep problems due to PTSD. ^{6 7 8 9 10}

Who Is on the Research Team?

Kerrie L Moreau, PhD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Are You a Good Fit for This Trial?

This trial is for veterans with PTSD who frequently experience nightmares. Participants should be interested in testing a wrist-wearable device called NightWare, aimed at improving sleep and potentially cardiovascular health.

Inclusion Criteria

I often have nightmares that disturb my sleep.

Resting blood pressure (BP) below 160/100 mmHg

Fasted glucose below 126 mg/dL

Exclusion Criteria

I do not have any uncontrolled health conditions like high blood pressure or active heart disease.

Shift workers

I have a seizure disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the NightWare device to improve sleep quality over 8 weeks

8 weeks

Measured before and after 8 weeks

Follow-up

Participants are monitored for changes in sleep quality and cardiovascular health after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NightWare

Trial Overview The study tests the effectiveness of NightWare, a prescription device worn on the wrist during sleep. It's designed to help veterans with PTSD by reducing nightmares and possibly enhancing cardiovascular health.

How Is the Trial Designed?

Group I: NightWare active Experimental Treatment 1 Intervention

Intervention with NightWare Therapeutic System

Group II: NightWare Sham Placebo Group 1 Intervention

NightWare app disabled; device will not deliver an intervention

NightWare is already approved in United States for the following indications:

Approved in United States as NightWare for:

• Post-traumatic stress disorder (PTSD) related nightmares

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A comprehensive analysis of 7,766,737 adverse event records from the FDA's MAUDE database revealed that 96.6% of reports came from manufacturers, highlighting a significant reliance on manufacturers for safety data.

Patient and nurse reports to the FDA were much more common than physician reports, with only 0.49% of physician reports submitted directly, indicating a need for improved physician engagement in reporting adverse events to enhance post-market surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporter's occupation and source of adverse device event reports contained in the FDA's MAUDE database. Kavanagh, KT., Brown, RE., Kraman, SS., et al.[2022]

In the UK, over 9000 adverse event reports related to medical devices highlight significant concerns about the effectiveness of current regulatory processes in ensuring patient safety.

Implementing 'safety cases'—a practice used in other safety-critical industries—could enhance transparency in the safety certification of medical devices and improve communication among manufacturers, service providers, regulators, and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety cases for medical devices and health information technology: involving health-care organisations in the assurance of safety. Sujan, MA., Koornneef, F., Chozos, N., et al.[2013]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

Patients with PTSD experience severe sleep disorders, with 87% reporting difficulty falling asleep and 88% suffering from nightmares, which significantly affect their daily lives.

There is a strong demand for targeted support for sleep disorders among PTSD patients, with 91% expressing interest in a therapeutic patient education program focused on improving sleep hygiene and managing nocturnal awakenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of sleep and therapeutic education needs of military with PTSD. Remadi, M., Dinis, S., Bernard, L., et al.[2023]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

The FDA's MedWatch program allows consumers and healthcare professionals to voluntarily report adverse events related to medical devices, which is crucial for identifying issues in home and nonclinical settings.

As the use of medical devices increases outside of clinical environments, active participation in reporting by users and caregivers is essential for the FDA to effectively address and manage device-related problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical devices, the FDA, and the home healthcare clinician. Simone, LK., Brumbaugh, J., Ricketts, C.[2014]

In a study of 97 individuals evacuated from the Fort McMurray fires, increased usage of the online treatment platform RESILIENT was strongly associated with significant reductions in PTSD, depression, and insomnia symptoms, highlighting the platform's efficacy.

The study found that both the number of modules accessed and the effort reported by participants midway through treatment were key predictors of symptom improvement, emphasizing the importance of user engagement in online therapeutic interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Usage Data of an Online Multidimensional Treatment to Promote Resilience After a Disaster]. Lebel, J., Flores-Tremblay, T., Binet, É., et al.[2021]

Citations

1. 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- ...

2. nightware.com nightware.com/clinical-trial/

Clinical Trial The investigators hypothesize that the NightWare Digital Therapeutic System will significantly improve sleep quality in participants. What is nightmare disorder ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03934658

Remote Study of NightWare for PTSD With Nightmares The investigators hypothesize that the NightWare digital therapeutic system will significantly improve sleep quality in participants with PTSD-Related ...

4. nightware.com nightware.com/wp-content/uploads/2024/03/Robertson-2023-J-Psych-and-Psych-Disord.pdf

Retrospective Assessment of Smart Watch Haptic ... By treating nightmares, this device can improve sleep quality and quantity,[17] which are both critical to good mental and physical health.

5. 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 ...

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

NIGHTWARE CLINICAL INFORMATION Given the lack of FDA-cleared therapies for nightmare disorder or PTSD-related nightmares, the low safety risks for the use of NightWare, and emerging evidence ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03934658

Remote Study of NightWare for PTSD With Nightmares This study will provide measures of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application)

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

DEN200033 Decision Summary - accessdata.fda.gov A 30-day, double-blind sham-controlled randomized clinical trial of the NightWare Digital Therapeutic was performed study the safety and effectiveness of the ...

9. 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 ...

10. nightware.com nightware.com/professionals/

Professionals The NightWare and control arms of the study did not significantly differ at baseline on the primary measures used to evaluate safety: Epworth Sleepiness Scale ( ...