A prospective, single arm, non-randomized, pivotal clinical validation study to evaluate the ability of the Kintsugi Voice Device (the Device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the Structured Clinical Interview for DSM-5 (SCID-5-RV) for up to 1000 English speaking adult patients ages 22 and older living in the United States. Recruitment will occur for 1 year and participation will be for up to 2 weeks
Study Type
OBSERVATIONAL
Enrollment
1,000
The Kintsugi Voice Device is intended to be used to screen for the presence of voice signals consistent with a current moderate to severe depressive episode in patients aged 22 and older. The device is intended to be used by care providers licensed to screen for depression and in settings where the screening for depression occurs. The device is neither to be used in lieu of a complete patient evaluation nor to supplant any of the clinician's standard assessments for the screening or diagnosis of depression. The Kintsugi Voice Device is comprised of a software API and machine learning model that utilizes recorded voice samples as inputs and outputs the detection of signals consistent with current moderate to severe depressive episode as outputs.
Kintsugi (Decentralized, Virtual Study)
Berkeley, California, United States
RECRUITING1. Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5
Achieve a composite lower bound of sensitivity greater than or equal to 70% and specificity greater than or equal to 70% for the KV Device relative to the high diagnostic confidence clinical reference standard as defined in Section 7.4.1 for which the device provides a result
Time frame: Day 1
Adjudicated Samples Sensitivity and Specificity
Evaluate sensitivity and specificity for all adjudicated samples for which the device provides a result
Time frame: Day 1
PPV and NPV Evaluation
Evaluate the Positive Predictive Value (PPV) and Negative Predictive Value (NPV)
Time frame: Day 1
Subgroup Analysis (Sensitivity and Specificity)
Perform subgroup analyses including but not limited to age, race, and ethnicity
Time frame: Day 1
Indeterminate Result Analysis
Measurement of the proportion of all participants for whom the device provides no result
Time frame: Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.