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Sana Treatment for PTSD
N/A
Waitlist Available
Led By Ronald Acierno, PhD
Research Sponsored by Sana Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, days 14 and 28
Awards & highlights
Summary
This trial tests if the Sana Device can help people with PTSD feel better when added to their usual treatment.
Who is the study for?
This trial is for US military members or veterans aged 18-65 with PTSD, who are in good health and have stable psychotropic drug therapy. They must understand English, provide consent, and commit to the study's schedule. Excluded are those with legal issues, significant medical conditions, pregnancy, visual/hearing impairments affecting the treatment, recent investigational drug/device use, severe tinnitus or photosensitivity disorders.
What is being tested?
The Sana Device is being tested for its effectiveness in treating PTSD when used alongside usual treatments. Participants will be assessed on how well they respond to this device as part of their therapeutic regimen.
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort from wearing the device or reactions related to light and sound exposure due to the nature of the Sana Device.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, days 14 and 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, days 14 and 28
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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.
Secondary study objectives
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.
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.
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.
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Treatment as UsualActive Control1 Intervention
Subjects will receive mental health care at the Ralph H. Johnson VA Medical Center or community-based outpatient clinic (CBOC).
Group II: Sana plus Treatment as UsualActive Control1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Neurostimulation and neuromodulation treatments, such as transcranial magnetic stimulation (TMS) and vagal nerve stimulation (VNS), work by modulating neural activity in specific brain regions associated with PTSD symptoms. These treatments aim to restore balance in neural circuits that are dysregulated due to trauma, potentially reducing symptoms like hyperarousal and re-experiencing.
This is crucial for PTSD patients as it offers a non-pharmacological option that can be used alongside or instead of traditional treatments. Pharmacological treatments, such as SSRIs and SNRIs, work by altering neurotransmitter levels to improve mood and reduce anxiety, while psychotherapies like cognitive-behavioral therapy (CBT) focus on changing maladaptive thought patterns.
Together, these treatments provide a multi-faceted approach to managing PTSD, addressing both biological and psychological aspects of the disorder.
A reciprocal inhibition model of alternations between under-/overemotional modulatory states in patients with PTSD.PTSD: from neurobiology to pharmacological treatments.
A reciprocal inhibition model of alternations between under-/overemotional modulatory states in patients with PTSD.PTSD: from neurobiology to pharmacological treatments.
Find a Location
Who is running the clinical trial?
Sana HealthLead Sponsor
2 Previous Clinical Trials
332 Total Patients Enrolled
Ralph H. Johnson VA Medical CenterFED
19 Previous Clinical Trials
5,414 Total Patients Enrolled
Ronald Acierno, PhDPrincipal InvestigatorRalph H. Johnson VA Medical Center
2 Previous Clinical Trials
280 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken drugs that can make you see or hear things that are not really there (like ketamine or psilocybin mushrooms) in the last month.You have a history or currently have a condition that affects your balance, such as seizures or vertigo.You have hearing problems, such as deafness or differences in hearing between your ears, that you have noticed and reported yourself.You have problems with your vision such as difficulty seeing light, colors, or brightness in one or both eyes, and your eyes see differently.You have an ongoing ear or eye infection, untreated allergies, or a current illness that may affect your hearing or vision.You are currently taking part in another study that involves medication or have taken an experimental drug or device within the past month.If you are taking medication for a mental health condition, you must have been taking the same medication for at least 4 weeks before enrolling in the study and continue taking it throughout the study.You have experienced ongoing and intense ringing in your ears, as determined by the investigator.You have had or are currently experiencing seizures triggered by exposure to light.You have recently had thoughts of hurting yourself or have a history of trying to harm yourself.You had surgery or a serious injury that required rehabilitation in the past 3 months. You currently have severe pain or are expected to experience changes in pain during the study.You have inflammation or broken skin around your eyes where the mask will be placed, according to what you have told us.You cannot participate if you have narcolepsy or untreated sleep apnea, based on what you tell us. However, if you have sleep apnea and are comfortable using both an apnea mask and the Sana device together, you may still be able to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment as Usual
- Group 2: Sana plus Treatment as Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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