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

NCT ID: NCT05319405

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-19
• Study Completion Date: 2023-12-01

Brief 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)

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sana plus Treatment as Usual

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.

Group Type: ACTIVE_COMPARATOR

Sana Device

Intervention Type: DEVICE

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.

Treatment as Usual

Subjects will receive mental health care at the Ralph H. Johnson VA Medical Center or community-based outpatient clinic (CBOC).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sana Device

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ralph H. Johnson VA Medical Center

FED

Sponsor Role: collaborator

Sana Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Acierno, PhD

Role: PRINCIPAL_INVESTIGATOR

Ralph H. Johnson VA Medical Center

Locations

Ralph H. Johnson Veteran Affairs Medical Center/Lowcountry Center for Veterans Research

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

CLN-013-A

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00119759

Identifier Type: -

Identifier Source: org_study_id