Study Design
This randomized pragmatic trial recruited patients from the database of a large health insurer (Aetna/CVS Health). All enrolled patients were initially prescribed a TAPS device and then randomized to treatment (TX) or standard of care (SOC) for one month of home use. Patients in the TX arm added TAPS to their physician-recommended care plan while patients in the SOC arm continued with their physician-recommended care plan. After completing one month of SOC, patients in the SOC arm crossed over into TX, and all patients continued with treatment for an additional 11 months of an ongoing open-label 12-month study phase (Figure S1).The study was approved by the Sterling institutional review board (Atlanta, GA, USA) prior to implementation of study procedures, and registered with 