Kintsugi Voice Device Pilot Study

NCT06374056 | Active Not Recruiting FDA Device

• 1 other identifier: 0458
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, single arm, non-randomized, pilot 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-CT) for up to 500 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.

Conditions

Depression; Depression Moderate; Depression Severe; Depression Mild

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5

  Determine the performance of the KV Device in discriminating the presence of a current significant depressive episode using the SCID-5-CT diagnosis of current MDD and/or MDE using sensitivity and specificity.

  Day 1

Secondary Outcomes (3)

• PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the SCID-5

  Day 1

• Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the Severity of the SCID-5-CT

  Day 1

• Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the PHQ-9

  Day 1

Study Arms (1)

Depressed

All study participants will undergo the same study procedures. All individuals will complete brief online assessments about their emotional and physical wellbeing, provide audio recorded voice responses to prompts, and complete the SCID-5-CT with a clinician licensed in their state of residence while being audio and video recorded for quality assurance purposes.

Device: Kintsugi Voice Device

Interventions

Kintsugi Voice Device DEVICE

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.

Depressed

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll up to 500 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.

You may qualify if:

• Age \>22 at the time of informed consent
• 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
• Fluency in English
• Availability for the duration of the study
• Resides in the United States at the time of consent and during completion of study
• Contributes to the approximately 50/50 depressed/healthy study population distribution

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kintsugi Mindful Wellness, Inc.: lead
• Sonar Strategies: collaborator
• Vituity Psychiatry: collaborator

Study Sites (1)

Kintsugi Mindful Wellness Inc.

Berkeley, California, 94707, United States

Location

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Biospecimen

Retention: NONE RETAINED

A

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 18, 2024
• Study Start: March 22, 2024
• Primary Completion: March 22, 2025
• Study Completion: July 22, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)