Study Evaluating the Kintsugi Voice Device for Detecting Moderate to Severe Depression in Adults 22 Years and Older in the United States

What this Trial Is About

Researchers are evaluating the Kintsugi Voice Device, a tool designed to assist in screening for moderate to severe depression by analyzing voice signals. This prospective, single-arm, non-randomized pivotal clinical validation study compares the devices output with diagnoses made by clinicians using the Structured Clinical Interview for DSM-5 SCID-5-RV. The study aims to enroll up to 1000 English-speaking adults aged 22 and older living in the United States to better understand the devices diagnostic capabilities. The study involves using the Kintsugi Voice Device, which includes software and a machine learning model that processes recorded voice samples to detect signs consistent with current moderate to severe depressive episodes. The device is intended for use by licensed care providers in clinical settings where depression screening occurs and is not meant to replace comprehensive clinical evaluations. Participants will be assessed for up to two weeks, during which their voice data will be recorded and analyzed. Participants will undergo evaluations comparing the devices results to clinician diagnoses using the SCID-5-RV. The study will measure outcomes such as sensitivity and specificity of the device relative to the clinical interview, positive and negative predictive values, and subgroup analyses. Participants must be available and willing to comply with all study procedures, including being video and audio recorded. The total participation time is up to two weeks, with assessments and monitoring occurring during this period.

Kintsugi Voice Device Pivotal Study