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

Trial Summary

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 data supports the effectiveness of the NightWare treatment for PTSD?

While there is no direct data on NightWare, research shows that sleep therapies like cognitive behavioral therapy for insomnia can help improve sleep issues in PTSD patients, which are a major symptom of the disorder. Additionally, wrist-worn devices have been used to measure changes in circadian rhythms, which can predict PTSD outcomes, suggesting potential benefits of wearable technology in managing PTSD symptoms. ^{1 2 3 4 5}

Is NightWare safe for use in humans?

There is no specific safety data available for NightWare or its related devices in the provided research articles. ^{6 7 8 9 10}

How does the NightWare treatment for PTSD differ from other treatments?

NightWare is unique because it uses a wristband to monitor and disrupt nightmares in real-time, focusing specifically on improving sleep quality for PTSD patients, unlike traditional therapies that may not directly target sleep disturbances. ^{2 3 11 12 13}

What is the purpose of this trial?

The purpose of this study is to learn more about the effectiveness of a prescription wrist-wearable device called NightWare (NW) on improving sleep in Veterans with nightmares related to posttraumatic stress disorder (PTSD). The investigators also want to learn whether it improves cardiovascular health among this population.

Research Team

Kerrie L Moreau, PhD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Eligibility Criteria

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

Willingness not to use any other application which collects heart rate data on the phone and watch used for NightWare

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

An open-label, 12-week clinical and sleep EEG study of nefazodone in chronic combat-related posttraumatic stress disorder. [2019]

2. France pubmed.ncbi.nlm.nih.gov

Evaluation of sleep and therapeutic education needs of military with PTSD. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Classification and Prediction of Post-Trauma Outcomes Related to PTSD Using Circadian Rhythm Changes Measured via Wrist-Worn Research Watch in a Large Longitudinal Cohort. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

[Usage Data of an Online Multidimensional Treatment to Promote Resilience After a Disaster]. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Sleep disturbances as predictors of prolonged exposure therapy effectiveness among veterans with PTSD. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. New Zealand pubmed.ncbi.nlm.nih.gov

Reporter's occupation and source of adverse device event reports contained in the FDA's MAUDE database. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Medical devices, the FDA, and the home healthcare clinician. [2014]

10. England pubmed.ncbi.nlm.nih.gov

Safety cases for medical devices and health information technology: involving health-care organisations in the assurance of safety. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Sleep variability in military-related PTSD: a comparison to primary insomnia and healthy controls. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Blunted Nocturnal Salivary Melatonin Secretion Profiles in Military-Related Posttraumatic Stress Disorder. [2020]

13. England pubmed.ncbi.nlm.nih.gov

Potential pleiotropic beneficial effects of adjuvant melatonergic treatment in posttraumatic stress disorder. [2017]