Recruiting

ADNM-20-Mil & SANA

Sponsor:

Henry M. Jackson Foundation for the Advancement of Military Medicine

Code:

NCT06885554

Conditions

Adjustment Disorders

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

SANA

Study Details

Brief summary:

Adjustment disorders (AjDs) - a group of mental health diagnosis given following exposure to a stressor that results in preoccupation, failure to adapt, and/or functional impairments - have consistently remained the most common mental health diagnoses in the US military across branches for more than a decade. AjDs can be dangerous and negatively affect military readiness by reducing availability of members and through use of resources to allow evacuations from combat. Diagnosing AjDs can be challenging as it is closely related to other well-defined mental health disorders and assessment and research on AjDs have historically been difficult due to the lack of clarity in the disorder's diagnostic criteria. However, the Adjustment Disorder New Module (ADNM-20) is a recently developed instrument that has shown promise.

In previous work, our team adapted the ADNM-20 to the US military population after finding that there was a need for an AjD-specific diagnostic instrument in this population; this instrument is referred to as the ADNM-20-Mil. The principal focus of this study is the longitudinal psychometric validation of the ADNM-20-mil. However, another goal of the proposed study is to pilot test the audio-visual stimulation device SANA for AjD as pilot testing such a device for AjD is a needed next step. Furthermore, the proposed, longitudinal study provides an ideal platform to test the ADNM-20-Mil's sensitivity to change in the context of this pilot trial to address this critical area of need.

Conditions

Adjustment Disorders

Study ID

NCT06885554

Start date

Oct 6, 2025

Status verified date

Jul, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SANA + Standard of Care (SOC)

Participants will be asked to use the SANA device and the Empatica monitoring bracelet for 28 days

no intervention: Standard of Care (SOC)

Participants will be asked to use the Empatica monitoring bracelet for 28 days

Interventions

SANA

SANA is an audio-visual stimulation device found to reduce symptoms commonly found in AjDs. SANA is an eye mask that delivers coordinated pulses of light and sound that facilitate relaxation in the wearer. The device's mechanism of action is neuromodulation through audiovisual stimulation (AVS). When the brain receives a stimulus through the eyes or ears, it emits a responsive electrical charge, called a Cortical Evoked Response (CER). The brain responds by synchronizing to it, a process known as Frequency Following Response (FFR). FFR can be used to trigger each electrical pattern to facilitate a state of relaxation. The Sana device utilizes AVS to induce FFR.

Primary outcome measure

  • Adjustment Disorder-New Module 20 for Military (ADNM-20-Mil) [ Time Frame: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3 ]
  • Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Baseline/T1, 3months/T2, 6months/T3 ]
  • PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3 ]
  • Adjustment Disorder Diagnosis [ Time Frame: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3 ]

Central Contacts and Locations

Central contacts

Jouhayna Bajjani-Gebara, PhD

301-295-1116jouhayna.bajjani-gebara@usuhs.edu

Locations

Navy Medicine Readiness and Training Command San Diego

Recruiting

San Diego, California, United States, 92134

Contacts

LTC Nathan Hydes, PhD

619-532-8551nathaniel.r.hydes.mil@health.mil

Wright Patterson Air Force Base

Recruiting

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

Contacts

MAJ Melissa Anderson, DNP, PMHNP-BC, PMH-C

937-257-6877melissa.g.anderson10.mil@health.mil

Brooke Army Medical Center

Recruiting

Fort Sam Houston, Texas, United States, 78234

Contacts

MAJ Elizabeth Johnson, PsyD

210-510-9357elizabeth.h.johnson30.mil@health.mil

More Information

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • Adjustment Disorders
  • Military

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry M. Jackson Foundation for the Advancement of Military Medicine on 2026-07-30.