Effectiveness of Sana Treatment in Post-Traumatic Stress Disorder (PTSD)

Study Overview
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Brief Summary
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The purpose of this study is to assess the effectiveness of the Sana Device when added to Treatment as Usual in participants with a diagnosis of post-traumatic stress disorder (PTSD)

Detailed Description
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This is a study designed to assess the effectiveness of the Sana Device when added to Treatment as Usual in participants with a diagnosis of post-traumatic stress disorder (PTSD) on severity of symptoms as measured by CAPS-5. We will use a 2-arm repeated measures randomized controlled design in which participants will be randomly assigned to either Sana plus Treatment as Usual (Sana+TAU) or Treatment as Usual (TAU).

Official Title
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A Pilot Investigation of the Effectiveness of the Sana Device in Management of PTSD: A Blinded Randomized Controlled Trial

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Device: Sana Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having served, or are currently serving, in the US military with a VA CPRS record. Willing to and capable of providing written electronic informed consent prior to the conduct of any study-related procedures. Adults, of any sex or gender, 18 to 65 years of age. Diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) clinical interview or CAPS-5 severity ≥ 25. Must be in good physical health based on self-report. Any psychotropic drug therapy regimen must be stable (unchanging) for at least 4 weeks prior to enrollment and remain steady throughout the study. Willing and able to comply with the study requirements, complete study assessments, and participate at scheduled times for the duration of the study. Able to understand, speak, and read English sufficient for the completion of study assessments. Provision of appropriate storage and charging for study equipment in a generally safe and dry condition. Exclusion Criteria: Pregnant, intending to become pregnant, or lactating females as self-reported. History or presence of photo-sensitive epilepsy or other photo-sensitive conditions as self-reported. History or presence of condition(s) that may affect balance, such as seizure disorders or vertigo as self-reported. History or presence of severe and continuous tinnitus, at investigator discretion Surgery or trauma requiring rehabilitation within the last 12 weeks as self-reported. Presence of cancer pain, acute pain following injury or other severe pain that would be anticipated to change during the course of the study, at discretion of the investigator. Vision impairments that affect perception of light, color, or brightness in one or both eyes, and differences in visual perception between eyes, per patient self-report. Deafness in one or both ears, perceived differences in hearing between ears, per patient self-report. Current ear or eye infection, untreated allergies, or acute illness that may affect eyes or hearing (e.g., due to congestion), per patient self-report. Presence of inflammation or broken skin around the eyes in the area of the mask, per patient self-report. Presence of narcolepsy or untreated sleep apnea, per patient self-report. 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. Any pending legal action that could prohibit participation or compliance in the study, per patient self-report. Recent history of or current evidence of suicidal intent or active suicidal behavior based on patient self-report at investigator discretion. Significant medical conditions or other circumstances which, in the opinion of the investigator, 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. Employment by the investigator or the study site, with direct involvement in the proposed study or other studies under the direction of the investigator or study site, or a family member of an employee or of the investigator. Use of drugs that can produce hallucinogenic effects (i.e., Ketamine or psilocybin mushrooms) within the past 4 weeks.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel 2-arm study in which participants will be randomly assigned to either Sana plus Treatment as Usual (Sana+TAU) or Treatment as Usual (TAU)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sana plus Treatment as Usual<br>Subjects will be loaned a Sana Device to use for 28 days and will also receive mental health care through the Ralph H. Johnson VA Medical Center. | Device: Sana Device<br>* Externally worn mask that physically contacts the skin of the face. The Sana Device delivers Audio Visual Stimulation (AVS) in the form of coordinated pulses of light (through closed eyelids) and sound at various frequencies.<br>|
| No Intervention: Treatment as Usual<br>Subjects will receive mental health care at the Ralph H. Johnson VA Medical Center or community-based outpatient clinic (CBOC). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the difference between Sana plus Treatment as Usual (Sana+TAU) and Treatment as Usual (TAU) on changes in PTSD symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) after 28 days. | A 30-item structured interview that can be used to diagnosis and assess PTSD symptoms and severity. | Baseline and Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the difference between Sana+TAU and TAU on changes in PTSD symptoms as measured by the PTSD Checklist - 20-item scale for DSM-5 (PCL-5) after 28 days. | A 20-item self-reported measure that assesses the 20 DSM-5 symptoms of PTSD. | Baseline, Days 14 and 28 | 
| To examine the difference between Sana+TAU and TAU on anxiety symptoms as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7) after 28 days. | The GAD-7 is a self-reported questionnaire for screening and measuring severity of generalized anxiety disorder. | Baseline, Days 14 and 28 | 
| To examine the difference between Sana+TAU and TAU on depression symptoms as measured by the Patient Health Questionnaire 9 (PHQ-9) after 28 days. | A self-reported questionnaire for screening and measuring severity of generalized anxiety disorder. | Baseline, Days 14 and 28 | 
| To examine the difference between Sana+TAU compared to TAU on perceived change in quality of life over TAU as measured by the Patient Global Impression of Change scale (PGIC) after 28 days. | A validated tool for screening, diagnosing, monitoring and measuring depression severity and scores each of the 9 Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV) related criteria. | Baseline, Days 14 and 28 |