Kintsugi Voice Device Pivotal Study

Kintsugi Voice Device SCID-5 Pivotal Study

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 Overview

• Status: Recruiting
• Conditions: Depression; Depression Moderate; Depression Severe; Depression Mild
• Intervention / Treatment: Device: Kintsugi Voice Device

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Dr. Kolby Walker D.O.; Phone Number: (209) 662-5369; Email: Kolby.Walker@vituity.com

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94707
      • Recruiting
      • Kintsugi (Decentralized, Virtual Study)
      • Contact: Dr. Kolby Walker; Phone Number: (209) 662-5369; Email: Kolby.Walker@vituity.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study will enroll up to 1000 English speaking subjects >22 years old. Only subjects who meet all eligibility criteria and sign the informed consent will be enrolled. Participants who do not meet the criteria required for participation will not be presented with the opportunity to participate. Screen failures will not be considered a part of this research study.

Description

Inclusion Criteria:

Age >22 at the time of informed consent Self-reported disruption to activities of daily living (e.g. missed scheduled healthcare appointments, unable to concentrate on tasks like reading, working, or completing daily activities, or difficult completing activities such as exercise, diet, or recreation) Access to a laptop, smartphone, tablet, or other device with a functioning microphone and access to the Internet Stated willingness to be video and audio recorded as part of the study Stated willingness to comply with all study procedures and availability for the duration of the study Functional English capacity in the home environment Availability for the duration of the study Resides in the United States at the time of consent and during completion of study

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Exclusion Criteria:

• Participants with at least one of the following conditions will be excluded:

Any impairment that impacts their ability to speak and/or use a computer to complete online surveys and/or a virtual clinician assessment (E.g., visual impairment, motor impairment, and/or hearing impairment) Any lifetime history of neurological disease that impacts their ability to speak and/or use a computer to complete online surveys and/or a virtual clinician assessment (E.g., Central Nervous System disorders, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, and/or Parkinson's Disease) Any lifetime history of Stroke, cognitive defect (E.g., dementia or Alzheimer's disease), and/or Traumatic Brain Injury Presence of voice disorders that impacts their ability to speak (E.g., acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia) Past or active heavy smokers (an average of >20 cigarettes per day) Subjects who have previously participated in any Kintsugi-sponsored study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. 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	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjudicated Samples Sensitivity and Specificity	Evaluate sensitivity and specificity for all adjudicated samples for which the device provides a result	Day 1
PPV and NPV Evaluation	Evaluate the Positive Predictive Value (PPV) and Negative Predictive Value (NPV)	Day 1
Subgroup Analysis (Sensitivity and Specificity)	Perform subgroup analyses including but not limited to age, race, and ethnicity	Day 1
Indeterminate Result Analysis	Measurement of the proportion of all participants for whom the device provides no result	Day 1

Collaborators and Investigators

• Sponsor: Kintsugi Mindful Wellness, Inc.
• Collaborators: Sonar Strategies; Kolby Walker, DO; Brittany Kimble

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 20245287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No