Welcome to the Clinical area of Sana Health

Before continuing, please read.

You are entering the Clinical area of the Sana Health Website. The data in this area of the website is intended for use by:

  • Healthcare professionals

  • Investigators currently participating in Sana Health Clinical Trials or those who are actively requesting additional information about clinical trials

The data in the Clinical area of the website contains future-looking statements and information regarding the use of the device for which no FDA clearance has been gained. The content of these pages does not constitute a recommendation for use of the Sana device for these purposes, as this clinical data requires the FDA review process to be completed prior to such use. The Sana device is currently indicated for use by healthy individuals for the purposes of enhanced rest and relaxation only.

If you are a clinical study participant, looking for the instructions for use for your clinical study device, please contact our Customer Service Team via text or phone call at 720-310-3370.

If you are interested in volunteering for future clinical trials, please email clinicalinquiry@sana.io.

BY CONTINUING INTO THESE PAGES YOU ACKNOWLEDGE THE ABOVE.

Clinical Trial Pipeline

PAST, CURRENT, UPCOMING STUDIES

Clinical evidence is a key pillar of Sana Health’s strategy for the Sana Device.

Sana Health has partnered with several highly regarded institutions to conduct studies focused on pain, mental health, and recovery. Below is an outline of the planned areas of focus and key partners. 

POC = Proof of Concept. 
BDD = Breakthrough Device Designation with FDA. This designation is given to select number of devices that the FDA considers will provide more effective treatment options for life-threatening or irreversible diseases. This designation provides SANA HEALTH with greater access to FDA experts in order to more efficiently address pre-market issues that may arise. Most importantly it guarantees reimbursement once device is cleared by FDA.

Interested in joining a future clinical trial with Sana Health?

Clinical Publications

A Pilot Investigation of the Effectiveness of the Sana Device in Management of PTSD: A Blinded Randomized Controlled Trial has been published by the Journal of Traumatic Stress Disorders & Treatment.

The publication explores the effectiveness of the Sana device, a non-invasive wearable device, in managing symptoms of PTSD*. This pilot randomized controlled trial used blinded methods to assess its impact compared to a control group. Preliminary results indicate that the device may help reduce PTSD symptoms, improve sleep quality, and lower anxiety levels. The findings support further research into the device as a potential therapeutic tool for PTSD management. Read the full publication here.

*The Sana Device is not cleared for the management of PTSD in any geography at this time, clinical investigations are ongoing.

Quality of life was significantly enhanced for subjects in DOD-funded PTSD study*

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*Full results are on file at Sana Health.

Results from RCT Neuropathic Pain Study show life-changing improvement in pain symptoms*

Sana Health’s pivotal Neuropathic Pain data is being submitted to the FDA for a De Novo

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*Full results are on file at Sana Health.

FAQs

  • The Sana is in clinical trials for a number of clinical applications but is not yet FDA-cleared for any specific indication. The FDA considers the Sana to be of non-significant risk, and no known serious adverse events or contraindications against use in combination with other drugs or therapies are known. However, the following patients should not use the Sana:

    • Persons under the age of 18

    • Pregnant women

    • History or presence of photo-sensitive epilepsy or other photo-sensitive conditions

    • Visually or hearing impaired, including those with a significant difference in hearing between ears or sight between eyes

    • Presence of inflammation or broken skin around the eyes

  • PTSD affects 20 million Americans and Neuropathic Pain impacts another 20 million Americans - both are in urgent need of non-drug solutions. The current drug treatments for PTSD show limited efficacy and may have harsh side effects. There are no medication options for Neuropathic Burning Pain.  The Sana device is an on-demand option that can fill the treatment gap and improve overall care.

  • View our additional FAQs.