Longitudinal voice monitoring in a decentralized Bring Your Own Device trial for respiratory illness detection.

The Acute Respiratory Illness Surveillance (AcRIS) Study was a low-interventional trial that examined voice changes with respiratory illnesses. This longitudinal trial was the first of its kind, conducted in a fully decentralized manner via a Bring Your Own Device mobile application. The app enabled social-media-based recruitment, remote consent, at-home sample collection, and daily remote voice and symptom capture in real-world settings. From April 2021 to April 2022, the trial enrolled 9151 participants, followed for up to eight weeks. Despite mild symptoms experienced by reverse transcription polymerase chain reaction (RT-PCR) positive participants, two machine learning algorithms developed to screen respiratory illnesses reached the pre-specified success criteria. Algorithm testing on independent cohorts demonstrated that the algorithm's sensitivity increased as symptoms increased, while specificity remained consistent. Study findings suggest voice features can identify individuals with viral respiratory illnesses and provide valuable insights into fully decentralized clinical trials design, operation, and adoption (study registered at ClinicalTrials.gov (NCT04748445) on 5 February 2021).