Please sign in to follow a disease.
Vibrating watch may disrupt PTSD nightmares, study finds
NCT ID NCT04040387
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Combat disorders are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a personalized mix of nerve stimulation and therapy rewire the brain for better mental health?
- Can a therapist on a screen ease both trauma and pain?
- Can cramming PTSD therapy into a few weeks help veterans cut substance use?
- Can targeting guilt ease PTSD in veterans?
- Zapping the Brain's fear hub: a new hope for PTSD?
- Can a drug combo or therapy dogs ease PTSD?