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RECRUITING

Kintsugi Voice Device Pivotal Study

Kintsugi Voice Device SCID-5 Pivotal Study

NCT06809907•Kintsugi Mindful Wellness, Inc.

Summary

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

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
•\-

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

Locations (1)

Kintsugi (Decentralized, Virtual Study)

Berkeley, California, United States

Key Dates

Start Date

March 27, 2025

Primary Completion Date

October 1, 2025

Completion Date

November 1, 2025

Last Updated

April 30, 2025

Enrollment

1,000

ESTIMATED participants

Conditions

DepressionDepression ModerateDepression SevereDepression Mild

Interventions

Kintsugi Voice Device

DEVICE

Contacts

Dr. Kolby Walker D.O.

CONTACT

(209) 662-5369 Kolby.Walker@vituity.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Kintsugi Voice Device Pivotal Study

Inclusion Criteria

Exclusion Criteria

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