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Article History

Received: 21 November 2025

Accepted: 27 February 2026

First Online: 17 March 2026

Declarations

:

: Study procedures were approved by the Program for the Protection of Human Subjects (PHHS) at the Icahn School of Medicine at Mount Sinai (ISMMS) (Protocol #18-2282) and registered on a national clinical trials registry (ClinicalTrials.gov Identifier: NCT04280562 Remote Participation (Within USA) Trial of the AVS Device (named the “Sana Device” developed by Sana Health, Inc, CO, USA). All procedures performed in the study followed the ethical principles of the Declaration of Helsinki. All participants signed an IRB-approved informed consent document prior to enrolment into the study. The study reporting adheres to CONSORT 2010 guidelines.

: Not applicable.

: At the time of submission, Richard Hanbury holds the title of CEO of Sana Health, Inc, Jeffrey Bower holds the title of VP of Analytics at Sana Health, Inc, Mark Robberson holds the title of Clinical Operations at Sana Health, Inc, and Natasha Bond holds the position of Head of Regulatory Affairs of Sana Health, Inc. The other authors have no conflicts of interest to declare.