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SANA Device for Adjustment Disorders in US Military

This study is testing a device called SANA for active duty US military members who have been diagnosed with an adjustment disorder (a mental health condition that can happen after a stressful event). SANA is an eye mask that uses light and sound to help you relax. The study wants to see if SANA, when used along with standard care, can help reduce symptoms of adjustment disorders. Researchers will also be using a new questionnaire, the ADNM-20-Mil, to better understand how adjustment disorders change over time. You may be able to join if you are 18-64, active duty military, and were diagnosed with an adjustment disorder within the last 3 months, without other serious mental health conditions or thoughts of suicide. The study aims to enroll 60 participants, but its current recruitment status is unclear.

Study design
This study is an interventional trial with 60 planned participants. You would be randomly assigned to either receive standard care or standard care plus the SANA device.
What's involved
If you use the SANA device, you would use it twice daily for 22 minutes per session for 28 days. Both groups will wear an Emaptica device 22 hours per day for 28 days. You will complete assessments at the start, after 28 days, after 3 months, and after 6 months.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 6 months after starting the study, with the last assessment taking place 5 months after device use (if applicable).

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NCT06885554

Adjustment Disorders in the US Military: Disease Trajectories and ADNM-20-Mil Validation

Recruiting
NAAges 18–64InterventionalTreatment
Henry M. Jackson Foundation for the Advancement of Military Medicine
~60 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:SANA

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adjustment Disorder-New Module 20 for Military (ADNM-20-Mil)
Measured over Baseline/T1, 28days/T1a, 3months/T2, 6months/T3
+3 more outcomes measured

Conditions

Adjustment Disorders

Explore related trials

Adjustment Disorder

Where it's being run

3 sites across 3 states
California1
Ohio1
Texas1

Who to contact

Jouhayna Bajjani-Gebara, PhD
[email protected]
301-295-1116
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Adjustment Disorder-New Module 20 for Military (ADNM-20-Mil)Baseline/T1, 28days/T1a, 3months/T2, 6months/T3

    The ADNM-20-Mil assesses symptoms of AjDs. It consists of two parts: The first part lists a number of stressful life events from which the participant identifies the most distressing event, and the second part lists 20 symptoms that are grouped into six subscales. Each item is rated on a 4-point Likert type scale that rates symptom frequency ranging from 1 (never) to 4 (often) with higher scores indicating worst severity of symptoms. The ADNM-20-mil will be collected via self-report.

  • Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)Baseline/T1, 3months/T2, 6months/T3

    The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a structured interview that assesses the severity of PTSD symptoms. The CAPS-5 will be administered to participants via a member of the CAPS-5 study team. This is not a scaled measure as it is a clinical interview.

  • PTSD Checklist for DSM-5 (PCL-5)Baseline/T1, 28days/T1a, 3months/T2, 6months/T3

    The PCL-5 is a standard 20-item assessment that will be used to assess the presence and severity of PTSD symptoms. Items on the PCL-5 correspond with the DSM-5 criteria for PTSD. Items are rated on a 5-point scale and responses range from 0 (not at all) to 4 (extremely). A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. DSM-5 symptom cluster severity scores can be obtained by summing the scores for the items within a given cluster. The PCL-5 will be collected via self-report.

  • Adjustment Disorder DiagnosisBaseline/T1, 28days/T1a, 3months/T2, 6months/T3

    License healthcare provider diagnosis of adjustment disorder from medical record assessed as the presence or absence of the affiliated ICD-10 or DSM-5 diagnostic code in the medical record. This will be collected retrospectively.