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Wrist device aims to zap PTSD nightmares and save hearts

NCT ID NCT06419959

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a prescription wrist device called NightWare that detects when a veteran with PTSD is having a nightmare and gently disrupts it without waking them. Researchers want to see if better sleep from fewer nightmares can also improve blood vessel and heart health. 125 veterans with PTSD and poor sleep will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NightWare (a wrist-wearable device that uses a proprietary algorithm to detect and disrupt nightmares without waking the user)
What this could lead to
If it works, this could offer a new, non-drug way to ease PTSD nightmares and potentially lower heart disease risk in veterans.
What could go wrong
This is a relatively small, early-stage study (125 people) testing a device, not a drug. The sham comparator group uses a disabled app, so placebo effects are possible. Success is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 88 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5). 2. Self-report having repetitive nightmares contributing to disrupted sleep; 3. Age 22 years (rationale is because the device has only been used in adults in 22 years and older); 4. Resting blood pressure (BP, \<160/100 mmHg); 5. Fasted glucose \<126 mg/dL; 6. Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher; 7. Epworth Sleepiness Scale (ESS): Question #8 score above "0" will prompt an additional question: Do you drive ("get behind the wheel") when you are drowsy? The answer must be "No" to be enrolled in the study due to safety concerns; 8. Wireless Internet and two power outlets in sleeping location; 9. Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare; Exclusion Criteria: 1. Unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer); 2. Active infection (note, anyone with an active infection would become eligible once the infection has ended); 3. Thyroid dysfunction, defined as an ultrasensitive TSH \<0.5 or \>5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement; or other problems that would interfere with participation in the study; 4. Use of insulin or sulfonylureas 5. Pregnancy or currently breast feeding; 6. Current history (past 3 months) of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate; 7. Participants will be excluded if they report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the Columbia-Suicide Severity Rating Scale \[C-SSRS\]). 8. Shift workers (due to circadian rhythm disruption); 9. Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy; 10. Nocturia that causes awakening from sleep; 11. Known sleep walking or acting out dreams (contraindication to NW use); 12. Diagnosis or suspicion of dementia; 13. Seizure disorder 14. Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    RECRUITING

    Aurora, Colorado, 80045-7211, United States

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