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

NCT05319405 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-02-06

No results posted yet for this study

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)

Conditions

  • Post Traumatic Stress Disorder

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Ralph H. Johnson VA Medical Center

    collaborator FED

  • Sana Health

    lead INDUSTRY

Principal Investigators

  • Ronald Acierno, PhD · Ralph H. Johnson VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2023-12-01
Completion
2023-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05319405 on ClinicalTrials.gov