Kintsugi Voice Device Pivotal Study

Recruiting

• Conditions: Depression; Depression Moderate; Depression Severe; Depression Mild

• Registration Number: NCT06809907
• Lead Sponsor: Kintsugi Mindful Wellness, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-01-30
• Study First Posted: 2025-02-05
• Study Start: 2025-03-27
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-10
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5	Day 1	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kintsugi (Decentralized, Virtual Study); 🇺🇸 Berkeley, California, United States