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Vibrating watch may disrupt PTSD nightmares, study finds

NCT ID NCT04040387

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a wearable device called NightWare that uses an Apple Watch to detect when a person is having a nightmare and gently vibrates to wake them just enough to stop the nightmare without fully waking them. The trial included 270 veterans and active-duty service members with PTSD and nightmare disorder. The goal was to see if the device improves sleep quality over 30 to 90 days compared to a sham device that does not vibrate.

What this could mean

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

Active substance
NightWare Therapeutic System (Apple Watch with vibration algorithm)
What this could lead to
If it works, this could offer a drug-free way to reduce PTSD nightmares and improve sleep quality for veterans.
What could go wrong
This is a small, early-stage trial with a sham control. The device may not work for everyone, and benefits might be modest or temporary.

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

270 people

The number who actually took part.

Started

Jul 2019

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Veterans and Active-Duty Service Member Enrolled in the Minneapolis/St. Cloud VAHCS, Louis Stokes VAHCS in Cleveland, Walter Reed National Military Medical Center, or Fort Belvoir Community Hospital * 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). * Equal to or older than 22 years of age. * Proficient in both reading and writing in the English language. * Pittsburgh Sleep Quality Index (PSQI) score 10 or higher. * Epworth Sleepiness Scale (ESS): On question #8 any 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. * Have repetitive nightmares contributing to disrupted sleep as reported by the patient * Wireless Internet and two power outlets where they sleep * Prazosin use; if yes, the patient may be included if tapered by prescribing provider. Taper must be completed and subject must be off prazosin for 2 days prior to enrollment. Exclusion Criteria: * Patient Health Questionnaire-9 (PHQ-9) score greater than or equal to 20. A score of 1 or more on the suicide ideation item of the PHQ-9 will trigger a risk assessment. * Uncontrolled atrial fibrillation * Current use of varenicline * Current use of beta-blockers (unless ophthalmic solutions) * Current use of non-dihydropyridines * Current use of Prazosin for the treatment of nightmares (can include patients 2 days following taper and discontinuation) This would be coordinated with the prescribing provider * Circadian rhythm disruption on a regular basis (shift-work) * Untreated Obstructive Sleep Apnea * Diagnosis of an active disorder of arousal from non-rapid eye movement sleep * Diagnosis of rapid eye movement sleep behavior disorder * Diagnosis of narcolepsy * Alcohol Use Disorders Inventory Test (AUDIT) (score of 8 or higher) * Drug Abuse Screening Test-10 (DAST-10) (score greater than 2) * Suspicion of nightmares being secondary to substance abuse or withdrawal * Diagnosis or suspicion of dementia * Previous or foreseeable legal proceedings involving nightmares or trauma * Nocturia that causes awakening from sleep * Known sleepwalking * Acting out of dreams prior to PTSD trauma

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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.

Contacts and locations

Locations

  • Louis Stokes Cleveland VA Medical Center

    Cleveland, Ohio, 44106, United States

  • Minneapolis VA Healthcare System

    Minneapolis, Minnesota, 55417, United States

  • Ralph H Johnson Veterans Affairs Medical Center

    Charleston, South Carolina, 29401, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20814, United States

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Other studies related to the condition(s) this trial covers.