US-based device company Sana Health is seeking breakthrough device designation from the US Food and Drug Administration (FDA) following the completion of a decentralised trial (DCT) from virtual contract research organisation (VCRO) Curavit Clinical Research, for its Sana virtual reality (VR) device.
The Sana device is a wearable, VR mask that reduces the symptoms of post-traumatic stress disorder (PTSD) using audiovisual stimulation (AVS). The device delivers AVS in the form of coordinated pulses of light through closed eyelids, and sound at various frequencies.
The trial (NCT05319405), funded by the US Department of Defense’s (DoD) Military Operational Medicine Research Program (MOMRP), recruited more than 45 patients from a Veteran’s hospital over 28 days. The study had a 76% participant retention rate and successfully remotely monitored patients using electronic patient-recorded outcomes assessments.
PTSD, commonly observed among military personnel, is a mental health condition stemming from exposure to traumatic events during service. Symptoms include flashbacks, severe anxiety, and nightmares, significantly impacting daily life. According to the National Center for PTSD, of the six million veterans that served in 2021, 10% of men and 19% of women were diagnosed with PTSD.
The use of VR in mental health is gaining traction, with common uses including exposure therapy to treat individuals with severe phobias or obsessive-compulsive disorder (OCD).
According to a report on GlobalData’s Pharma Intelligence Center, the global VR market will reach $51bn by 2030, growing at a compound annual growth rate (CAGR) of 27% from $5bn in 2020. VR has been noted as being a promising alternative to pharmacological intervention in the therapy space, as it is cost-effective and less time-consuming for patients, healthcare professionals, and primary carers.
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In the announcement accompanying the data, Sana Health CEO Richard Hanbury said: “Curavit provided us with a streamlined path to capture real-world data with the utmost professionalism, allowing us to conduct a high-quality and successful trial. Thanks to Curavit, we are moving onto a larger pivotal study, funded by MOMRP (DoD).”
Launched in 2020, Curavit designs and provides DCT execution – DCTs are trials where participants take part in the study remotely, minimising the necessity for frequent visits to a research site, and removing geographic and physical barriers to participation and execution of trials.