VA Pilot Program , By Invitation Only

You've been selected for the NightWare pilot program.

Your care team has identified you as a candidate for NightWare , an FDA-cleared prescription digital therapeutic that helps reduce sleep disturbance related to nightmares in adults with PTSD.[1] This pilot brings a proven treatment to the VA at no cost to you.

FDA-Cleared Class II De Novo , Nov. 2020 [1]
2,000+ Patients served since 2021 [8]
78% Reported improved sleep [8]
Person sleeping peacefully while wearing a smartwatch

Understand the science. Hear the stories.

Watch How NightWare Works and hear directly from patients whose sleep has been transformed.

01 — The Science
How NightWare Works
See how NightWare monitors your sleep in real time and delivers gentle haptic cues to interrupt nightmares — without waking you up.
Watch the explainer
02 — The Impact
Real Patients. Real Results.
Veterans share what happened when they finally got a full night’s sleep — and what it meant for their lives. Individual results may vary.[8]
Hear their stories

Nightmares aren't just bad dreams.

For many veterans with PTSD, nighttime is the hardest part. You're not alone. This is a treatable medical condition, not something you have to live with.

Sleep disruption is real

Nightmare disorder affects a significant proportion of adults with PTSD and is associated with reduced quality of life, increased hyperarousal, and higher rates of suicidality.[3] It disrupts sleep architecture and makes everything harder during the day.

Current options fall short

Existing first-line treatments, including prazosin and Image Rehearsal Therapy (IRT), leave a substantial portion of patients with inadequate symptom relief.[4][5] If you've tried treatments that didn't fully work, you're not the exception.

This isn't about willpower

You can't will yourself to stop a nightmare. NightWare addresses a gap in the treatment landscape by providing a passive, device-based intervention that does not require active patient engagement during sleep.[2]

A common, undertreated condition

Nightmare disorder is a distinct, treatable diagnosis[7] and one of the most common and most undertreated symptoms of PTSD.[3] The 2023 VA/DoD Clinical Practice Guideline acknowledges that data are inconclusive regarding the best intervention for nightmares , a treatment gap NightWare was built to address.[5]

"I'd tried prazosin. I'd tried therapy. Nothing touched the nightmares. This was the first thing that actually let me sleep through the night."
NightWare Patient [8] , Individual results may vary

NightWare is FDA-cleared and clinically validated.

This is not a clinical trial. NightWare has been used by thousands of patients. This pilot brings a proven therapy into the VA system.

RCT
Randomized, sham-controlled trial in military veterans demonstrated statistically significant improvement in sleep quality[2]
2,000+
Patients served since 2021 across military and civilian populations[8]
78%
Of patients in the management program reported clearly improved sleep[8]

Clinical Validation

Statistically significant improvement in sleep quality when patients enroll in patient management program and use NightWare at least 50% of the time.

PSQI
Sleep Quality Index
0.72
Large Effect Size
P-value: 0.016*
NWL
Likert Scale
0.94
Large Effect Size
P-value: 0.002***
p = .016
Active vs. Sham PSQI improvement
−4.1
Active arm
vs. sham −1.9[2]

Nicholas D. Davenport, PhD; J. Kent Werner, MD, PhD 2023
DOI: https://doi.org/10.5664/jcsm.10338

Observational Study Results

636 Military Personnel Study

Real-world outcomes from active-duty and veteran populations using NightWare in a clinical setting.

78%
Reported clearly improved sleep and decreased nightmares
21%
Reported significant life-changing improvements
+1 Hour
Average increase in sleep duration[2]
View Study ↗

Robertson BD, et al., J Psychiatry Psychiatric Disord 2023
DOI:10.26502/jppd.2572-519X0199

Important distinction: This is a pilot program, not a clinical trial. NightWare is already FDA-cleared and in clinical use.[1] The VA pilot is about expanding access to a proven therapy within the VA system. Your experience helps make the case to bring it to every veteran who needs it. As with any treatment, not all patients will respond.[2]

Why Traditional Approaches Fall Short

Treatment Limitation NightWare Advantage
Prazosin (medication) Failed to outperform placebo in large VA trial (n=304)[4] Non-pharmacologic; no drug interactions or side effects
Image Rehearsal Therapy Requires specialized sessions; high dropout rates; limited scalability[5] Passive, automatic; no active effort required during sleep
Sleep Trackers Monitor only, no intervention capability Real-time detection and haptic intervention in the moment
CPAP Devices Addresses breathing disorders, not trauma-driven nightmare response Specifically designed for nightmare disorder in PTSD[1]

The Complete Therapeutic Platform

NightWare is an FDA-cleared Class II medical device that monitors sleep patterns to identify and interrupt a patient's nightmares in real-time — without drugs or invasive therapy.

Only FDA-Indicated Nightmare Therapy
Patented algorithm identifies and interrupts a nightmare in real time for better sleep quality. First-mover advantage with 2,000+ patients served since 2021.
Passive & Non-Invasive by Design
No pills, no therapy sessions, no active effort required during sleep. NightWare works automatically — patients simply wear the watch to bed.
AI Learns From Every Night
As NightWare scales, its AI enables continuous personalized therapy, seamless expansion into adjacent sleep disorders, and high-value clinical data generation.
NightWare iPhone app
Apple Watch running NightWare

Works while you sleep. No drugs. No effort.

NightWare uses an Apple Watch to detect physiologic signs of nightmares and deliver gentle haptic interventions, without waking you.[1]

Step 01

Wear an Apple Watch to bed

NightWare runs on a standard Apple Watch. Put it on before sleep. That's all you need to do.[1]

Familiar technology, nothing invasive
1
2
Step 02

NightWare learns your sleep patterns

The device continuously monitors your heart rate and movement during sleep, building a personalized baseline of your normal sleep patterns.[1][2]

Some patients notice changes within the first few nights; for others, it may take one to two weeks for the algorithm to fully calibrate.[2]

Step 03

Detects signs of a nightmare

When NightWare detects physiologic disturbances consistent with a nightmare (elevated heart rate, restless movement) it intervenes in real time.[1]

Real-time biometric monitoring
3
4
Step 04

Delivers a gentle vibration

A mild haptic pulse on your wrist is designed to redirect your sleep away from the nightmare without fully waking you.[1][2]

No pills, no side effects
"My wife noticed before I did. She said I stopped thrashing in my sleep. I stopped waking up drenched in sweat. That's when I knew it was working." NightWare Patient [8]
Step 05

Adapts to you over time

NightWare's algorithm personalizes to your sleep profile. The more you use it, the more precisely it can detect and respond to your nightmares.[1]

In the clinical trial, outcomes were strongest among patients who used the device consistently (at least 50% of nights).[2]

Higher adherence = better outcomes
5

Real experiences from real patients.

Individual results may vary. These statements reflect individual patient experiences and are not guarantees of outcomes.[6]

Ingrid
Veteran — NightWare Patient
Joana
Veteran — NightWare Patient
Kris
Veteran — NightWare Patient
Wendell
Veteran — NightWare Patient
Ronnie
Veteran — NightWare Patient
Michael
Veteran — NightWare Patient

Patient testimonials are provided to illustrate individual experiences. These are not representative of all patient outcomes. NightWare is a prescription device; individual results may vary. Testimonials were collected as part of NightWare's patient management program.[6]

What to expect, step by step.

Your VA care team will guide you through each phase. Here's what the process looks like.

Today

Enrollment & Setup

Your clinician confirms your eligibility and walks you through the program. You'll receive an Apple Watch with NightWare pre-configured and ready to use.

Week 1–2

Calibration Period

NightWare begins learning your sleep patterns. Some patients notice changes within the first few nights; for others it may take one to two weeks for the algorithm to fully calibrate.[2]

"Within three nights, I woke up and realized something was off. I don't remember having any dreams, but I feel extremely rested for once." NightWare Patient [8]
Week 3–4

First Check-In

A brief check-in with your care team to discuss your experience. A short survey helps the VA track progress across the pilot program.

Ongoing

Continued Use & Periodic Feedback

Keep wearing NightWare nightly. You'll have periodic check-ins and brief surveys. NightWare continues to adapt and improve for you. Higher adherence is associated with better outcomes.[2]

End of Pilot

Outcome & Continuation

If NightWare is working for you, you keep the device and continue using it as part of your ongoing care. Your participation helps build the case for VA-wide adoption.

"Your feedback doesn't just help you. It helps bring this to every veteran dealing with PTSD-related nightmare disorder." NightWare VA Pilot Program

What we ask, and what you get.

Your commitment

  • Wear the Apple Watch each night while sleeping
  • Complete brief periodic surveys about your experience
  • Attend scheduled check-ins with your VA care team
  • Continue your existing PTSD treatment plan[6]

What you receive

  • Access to NightWare at no cost for the duration of the pilot
  • If it works for you, you keep the device
  • Ongoing support from your VA care team
  • The knowledge that your feedback helps bring this to fellow veterans
Your feedback doesn't just help you. It helps build the case to make NightWare available to every veteran dealing with PTSD-related nightmare disorder. You're part of something bigger.

Nothing to worry about.

NightWare was designed with your comfort and safety in mind.[1]

"I was skeptical. How is a watch going to help with nightmares? But after a week, I was sleeping longer, feeling better during the day. My therapist noticed I was more engaged in sessions."
NightWare Patient [8]

Non-invasive

Just an Apple Watch on your wrist. Nothing surgical, nothing implanted.[1]

No drugs

No medications, no pharmacologic side effects, no drug interactions.[1]

Data is private

Your sleep data is secure and used only for your care.

You're in control

You can stop using NightWare at any time, no questions asked.

Common Questions

No. NightWare is designed to be used as part of a comprehensive treatment plan for PTSD[6], including therapy, medication, whatever your care team has in place. Its mechanism of action (real-time physiologic monitoring with haptic feedback) is clinically distinct from pharmacologic and behavioral approaches.[2]
No. NightWare received FDA De Novo clearance on November 6, 2020 (DEN200033) and has been in clinical use since 2021.[1] This pilot is about bringing a proven, cleared therapy into the VA system, not testing something new. Your experience helps the VA evaluate how best to offer NightWare widely.
Individual results vary, as with any treatment.[6] In the clinical trial, outcomes were strongest among patients who used the device consistently (at least 50% of nights).[2] If NightWare isn't the right fit for you, there is no penalty. You return the device and continue with your current care plan.
NightWare is designed to redirect your sleep away from the nightmare without waking you.[1] In the clinical trial, participants in the active arm reported better sleep quality, suggesting the device does not disrupt overall sleep architecture.[2]
No. As part of the VA pilot program, NightWare is provided to you at no cost. There are no hidden fees or charges.
Many patients adjust within a night or two. The Apple Watch is lightweight, and you can adjust the band for comfort. In the clinical trial, average device usage was over 60% of nights, suggesting most participants found the device acceptable for regular nighttime use.[2]

Ready to get started?

Your care team is here to walk you through enrollment and answer any remaining questions.

For Patients

Begin Your Enrollment

Talk to your VA care team today. Confirm your eligibility, receive your configured Apple Watch, and start sleeping with NightWare tonight.

1
Confirm enrollment with your clinician
2
Receive your configured Apple Watch
3
Start sleeping with NightWare tonight
For Clinicians

Enroll Your Patient

Walk through enrollment paperwork and device setup with your patient. Confirm eligibility criteria, discuss expectations, and schedule the first follow-up check-in.

NightWare is intended for use under clinician supervision as part of a comprehensive PTSD treatment plan.[6]

References

All claims on this page are sourced from FDA regulatory documents, peer-reviewed clinical literature, VA/DoD clinical practice guidelines, and NightWare data on file. Superscript numbers throughout the page correspond to the references below.

  1. U.S. Food and Drug Administration. De Novo Classification Request: NightWare Kit. DEN200033. Cleared November 6, 2020. Product Code: QMT. Classification: Class II (Special Controls). Indication: "The NightWare digital therapeutic is indicated to provide vibrotactile feedback on an Apple Watch based on an analysis of heart rate and motion during sleep for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD)." FDA De Novo Database FDA Regulatory
  2. Davenport ND, Werner JK. A randomized sham-controlled clinical trial of a novel wearable intervention for trauma-related nightmares in military veterans. Journal of Clinical Sleep Medicine. 2023;19(2):361–369. doi:10.5664/jcsm.10338. Key findings: In the high-adherence subgroup (device use ≥50% of nights; n=48), active-arm participants showed significantly greater improvement in PSQI scores (active −4.1 vs. sham −1.9; p=.016; effect size 0.72) and NightWare Likert Scale scores (active +6.1 vs. sham +2.7; p=.002). Active-arm participants gained approximately 1 additional hour of sleep on average. 72 veterans enrolled; 65 completed the trial. Peer-Reviewed RCT
  3. Levin R, Fireman G. Nightmare prevalence, nightmare distress, and self-reported psychological disturbance. Sleep. 2002;25(2):205–212. See also: Nadorff MR, Nazem S, Fiske A. Insomnia symptoms, nightmares, and suicidal ideation in a college student sample. Sleep. 2011;34(1):93–98. Nightmare disorder in PTSD populations is associated with reduced quality of life, increased hyperarousal, and higher rates of suicidality independent of PTSD severity. Peer-Reviewed Literature
  4. Raskind MA, Peskind ER, Chow B, et al. Trial of prazosin for post-traumatic stress disorder in military veterans. New England Journal of Medicine. 2018;378(6):507–517. doi:10.1056/NEJMoa1507598. In this large multicenter VA trial (n=304), prazosin did not demonstrate statistically significant improvement over placebo for PTSD-related nightmares or sleep quality in military veterans with chronic PTSD. Peer-Reviewed RCT
  5. Department of Veterans Affairs & Department of Defense. VA/DoD Clinical Practice Guideline for the Management of Posttraumatic Stress Disorder and Acute Stress Disorder. Version 4.0. 2023. The guideline found insufficient evidence to recommend for or against the use of prazosin for nightmares or sleep disturbance associated with PTSD, acknowledging the treatment gap in nightmare management. VA/DoD CPG Clinical Guideline
  6. NightWare, Inc. FDA-cleared labeling and Instructions for Use. NightWare is a prescription-only, FDA-cleared digital therapeutic indicated for the treatment of nightmare disorder in adults with PTSD. NightWare is not a standalone therapy for PTSD and should be used in conjunction with clinician-directed care. Individual results may vary. The device does not diagnose, cure, or prevent any disease. Product Labeling
  7. American Academy of Sleep Medicine. Position Paper for the Treatment of Nightmare Disorder in Adults. Journal of Clinical Sleep Medicine. 2018;14(6):1041–1055. doi:10.5664/jcsm.7178. Acknowledges nightmare disorder as a distinct, treatable condition and reviews available treatment options. Clinical Guideline
  8. NightWare, Inc. Data on file. Patient management program data, 2021–2025. Includes reported outcomes (78% of patients reporting clearly improved sleep; 80%+ patient satisfaction), total patients served (2,000+), and patient testimonial content collected within the NightWare management program. Individual results may vary; these figures reflect aggregate program data, not controlled trial outcomes. Data on File
Important Safety & Product Information: NightWare is a prescription-only, FDA-cleared (Class II, De Novo DEN200033) digital therapeutic indicated for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). NightWare is not a standalone therapy for PTSD and should be used in conjunction with clinician-directed care as part of a comprehensive PTSD treatment plan. NightWare uses Apple Watch sensors to detect physiologic disturbances consistent with nightmares and delivers haptic (vibrotactile) feedback. The device does not diagnose, cure, or prevent any disease. Individual results may vary; as with any treatment, not all patients will respond. In a randomized controlled trial, NightWare demonstrated statistically significant improvement in patient-reported sleep quality compared to sham device in adherent users. NightWare is intended for use under clinician supervision. For full prescribing information, refer to NightWare Instructions for Use or contact NightWare, Inc.