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Smartwatch vibration therapy tested for warfighter nightmares and insomnia

NCT ID NCT07288593

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether a special smartwatch can improve sleep in warfighters who have trouble sleeping due to PTSD, traumatic brain injury, or stress. The watch detects signs of stress during sleep, like a fast heart rate, and gives gentle vibrations to calm the body without waking the person. Researchers will track sleep quality, mood, and thinking over 30 days to see if the device helps.

What this could mean

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

Active substance
NightWare smartwatch (device that detects stress signals during sleep and delivers gentle vibrations)
What this could lead to
If it works, this could offer a drug-free way to improve sleep quality and daytime function in military personnel with PTSD or TBI.
What could go wrong
This is an early-stage study with only 180 participants. The device may not work for everyone, and results may not apply to civilians.

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 180 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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

18 to 62 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: * Defense Enrollment Eligibility Reporting System (DEERS) Eligible * Current or former military service member * Able to read and understand English language without the use of an interpreter * Habitual bedtime between 9:00 PM and 1:00 AM * Aged 18-62 (inclusive) * Able to commit to study procedures Exclusion Criteria: * Use of alpha or beta-receptor active medications or prescribed sleep aids in the last 3 months * Started use of SNRIs or SSRIs in the last 3 months * Pregnant * Receiving ongoing and extensive treatment for a new or acute psychiatric disorder within 90 days, other than routine follow-up and care * Starting concurrent evidence based psychiatric treatment within the past three months * Diagnosis of a serious medical condition (i.e., late-stage cancer or heart disease) * Routine night shift work in the past 3 months * Unstable neurological disease/autonomic disorders/ heart conditions/psych/ sleep or other unstable disorder as determined by the Principal Investigator/Associate * Investigators determined by clinical interview by Mini international neuropsychiatric interview and medical health questionnaire * Excessive alcohol use as determined by the AUDIT-C (AUDIT-C \> 3) * Started using any other medication (prescribed or over-the-counter) for the purpose of improving sleep in the last 90 days (e.g., barbiturates, benzodiazepines, melatonin, natural supplements and herbs, antidepressants, antihistamines, etc.) * Receiving treatment for substance use disorder within 90 days from the start of the study * Evidence of moderate or severe Obstructive Sleep Apnea (OSA): Determined by the STOP-BANG questionnaire: STOP-BANG greater than 5 Determined by EMR PSG records: moderate or severe OSA \[apnea-hypopnea index (AHI)≥15\] * Clinically significant suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) * Currently participating in other research studies for improving sleep * Currently participating in other research studies for improving PTSD * Currently in therapy for the primary purpose of improving sleep (e.g., CBT-I) * Currently undergoing other treatment to improve sleep (e.g., acupuncture) * History or diagnosis of any of the following sleep disorders: narcolepsy, shift-work disorder or circadian rhythm disorders * Prone to problems with venipuncture including fainting, hematoma, and infection * Moderate and high nicotine dependence based on the Fagerstrom Test for Nicotine Dependence (\> 4 on the Fagerstrom Test for Nicotine Dependence) High caffeine dependence based on the Caffeine Dependence Questionnaire (\> 30 on the Caffeine Dependence Questionnaire) * Currently experiencing a neurological disorder (e.g., stroke, Parkinson's, MS, etc.) * Exclusion for optional MRI visit: Metal in body that is ferromagnetic / incompatible with MRI or other safety issues and indicated by screen Previous adverse reactions to sleep deprivation Illicit drug use as determined by participant self-report Alcohol in system at time of MRI overnight as determined participant self report Nicotine use in the last 3 months For poor sleep group: TBI History of epilepsy or suspected seizure disorder.

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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

    2 sites. 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

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • Walter Reed National Military Medical Center/Uniformed Services University

    Bethesda, Maryland, 20814, United States

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