Post Traumatic Stress DisorderNCT05319405
Effectiveness of Sana Treatment in Post-Traumatic Stress Disorder (PTSD)
A study testing Sana Device in people with Post Traumatic Stress Disorder, run by Sana Health at 1 site in United States.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Sana Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson Veteran Affairs Medical Center/Lowcountry Center for Veterans Research
Charleston, South Carolina, 29401
About this study
Official title: A Pilot Investigation of the Effectiveness of the Sana Device in Management of PTSD: A Blinded Randomized Controlled Trial
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)
Read the detailed description
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).
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Sana Device
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sana DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sana plus Treatment as Usual | Active comparator | 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. Receives: Device: Sana Device |
| Treatment as Usual | No intervention | Subjects will receive mental health care at the Ralph H. Johnson VA Medical Center or community-based outpatient clinic (CBOC). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 28
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Days 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start19 Apr 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ralph H. Johnson VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Ronald Acierno, PhD, Principal investigator, Ralph H. Johnson VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319405
- Sponsor's protocol ID
- Pro00119759
- Other IDs
- CLN-013-A
- Status last verified
- Nov 2023
- First submitted
- 1 Apr 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Investigation of the Effectiveness of the Sana Device in Management of PTSD: A Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05319405
- Acronym / sponsor ID
- Pro00119759
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Sana HealthIndustry (pharma, biotech, devices)
- Collaborators
- Ralph H. Johnson VA Medical Center
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Sana plus Treatment as Usual | Active comparator | Device: Sana DeviceSubjects 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. |
| Treatment as Usual | No intervention | –Subjects will receive mental health care at the Ralph H. Johnson VA Medical Center or community-based outpatient clinic (CBOC). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sana DeviceExternally 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. | Device | Sana plus Treatment as Usual |
Primary outcome
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.
Time frame: Baseline and Day 28
A 30-item structured interview that can be used to diagnosis and assess PTSD symptoms and severity.
4 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Days 14 and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Post Traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Acierno, PhD principal investigator
Ralph H. Johnson VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sana Device in people with Post Traumatic Stress Disorder, run by Sana Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.