NCT05319405

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Sana Health · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-19
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-04-08
• Last updated: 2024-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study