NCT05554042

Kintsugi Voice Device Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 132 (actual)
• Sponsor: Kintsugi Mindful Wellness, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

The Kintsugi Voice Device Pilot Study is a two arm pilot diagnostic accuracy study. Eligible enrolled participants will complete the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) instruments, as well as complete a remote video-recorded Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-5 (SCID) with a trained psychiatrist. This study seeks to evaluate the ability of the Device to aid clinical assessment for depression and anxiety by comparing its output with the established diagnostic standard consisting of a diagnosis made by a specialist clinician based on DSM-5 criteria. The order of the assessments will be randomized. Audio captured during the SCID interview will be inputted into a machine learning model to determine the diagnostic accuracy of the Kintsugi Voice Device.

Detailed description

This is a prospective study of up to 100 subjects, ages \>22 years of age. The study is striving for a 50%/50% split of subjects who have depression and/or anxiety and subjects who do not have depression and/or anxiety.

Conditions

• Depression, Anxiety

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Kintsugi Voice Device	The Kintsugi Voice Device is an API with an underlying machine learning algorithm that drives the Device outputs. Depression and Anxiety are separate algorithms. The Device is designed to be adjunct to clinical assessment and estimate the presence of vocal characteristics consistent with a significant depressive episode and/or a clinically significant anxiety state, which are a necessary condition for the diagnosis of lifetime mood disorders, such as major depressive disorder and/or generalized anxiety disorder. Kintsugi Voice Device is not to be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.

Timeline

• Start date: 2022-09-23
• Primary completion: 2023-07-05
• Completion: 2023-07-05
• First posted: 2022-09-26
• Last updated: 2024-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study