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Military mental health: new diagnostic tool and Light-Sound device under study

NCT ID NCT06885554

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 3 times

Summary

This study aims to validate a new questionnaire (ADNM-20-Mil) designed to better diagnose adjustment disorders in active-duty US military personnel. It also pilots a device called SANA, which uses light and sound pulses to promote relaxation. Sixty participants with a recent adjustment disorder diagnosis will be followed over time to see how their symptoms change and whether 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
SANA (audio-visual stimulation device)
What this could lead to
If successful, this could provide a reliable diagnostic tool for adjustment disorders in the military and suggest that a simple relaxation device may help reduce symptoms.
What could go wrong
This is a small, early pilot study with only 60 participants, so results may not apply broadly. The device's effectiveness for adjustment disorders is untested, and the main goal is validating a questionnaire, not proving treatment works.

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 60 people

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

Started

Oct 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 64 years

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: * Age 18-64 * Serving as active duty in the US Military * Diagnosed with adjustment disorder (with or without depression and/or anxiety) within the last 3 months * No other mental health diagnosis (e.g., schizophrenia spectrum and other psychotic disorders, substance use disorder, bipolar and related disorders, TBI) * No current thoughts of or serious risk of suicide * Willing and available (e.g., no upcoming deployments or station changes within the next 6 months) to be participate in all study activities if eligible and enrolled * Any psychotropic drug therapy regimen must be stable (unchanging) for at least 4 weeks prior to enrollment and remain steady throughout the study * Must have and be willing to use an internet-enabled smartphone or tablet for the study * Provision of appropriate storage and charging for study equipment in a generally safe and dry condition * In treatment through the Military Health System for adjustment disorder Exclusion Criteria: * Significant medical conditions or other circumstances which would preclude compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may prevent the patient from safely participating in study. * Does not meet the eligibility criteria * Unable to read, speak, or comprehend English * Unable or unwilling to give informed consent * No current pregnancy or intention/planned pregnancy during study duration, or lactation * Study participants of childbearing potential who are unwilling to use an effective method of contraception during the use of SANA device * History or presence of photo-sensitive epilepsy or other photo-sensitive condition * History or presence of condition(s) that may affect balance, such as seizure disorders or vertigo * History or presence of severe and continuous tinnitus * History or presence of migraine headaches * Surgery or trauma requiring rehabilitation within the last 12 weeks * Presence of cancer pain, acute pain following injury or other severe pain that would be anticipated to change during the course of the study * Vision impairments that affect perception of light, color, or brightness in one or both eyes, and differences in visual perception between eyes * Deafness in one or both ears, perceived differences in hearing between ears * Current ear or eye infection, untreated allergies, or acute illness that may affect eyes or hearing (e.g., due to congestion) * Presence of inflammation or broken skin around the eyes in the area of the mask * Presence of narcolepsy or untreated sleep apnea. Note: presence of sleep apnea is permitted, so long as patients feel comfortable to use both apnea mask and Sana device in conjunction. * Participation in any other clinical study in which medication(s) are being delivered or have used an investigational drug or device within the last 30 days. * Current thoughts of suicide

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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

    3 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

  • Brooke Army Medical Center

    RECRUITING

    Fort Sam Houston, Texas, 78234, United States

  • Navy Medicine Readiness and Training Command San Diego

    RECRUITING

    San Diego, California, 92134, United States

  • Wright Patterson Air Force Base

    RECRUITING

    Wright-Patterson Air Force Base, Ohio, 45433, United States

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