Kintsugi Voice Device Study

NCT05554042 | Completed FDA Device

• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression, Anxiety

Keywords

mental health; depression; anxiety; remote research; artificial intelligence; diagnostic

Outcome Measures

Primary Outcomes (2)

• Sensitivity and Specificity of the Kintsugi Voice Device for a Significant Depressive Episode

  Discriminates the presence of a significant depressive episode using the Structure Clinical Interview for the Diagnostic Statistical Manual for Mental Disorders-5 as the ground truth, diagnostic standard

  Through study completion, on average 2 weeks

• Sensitivity and Specificity of the Kintsugi Voice Device for a Significant Anxiety State

  Discriminates the presence of a significant anxiety state using the Structure Clinical Interview for the Diagnostic Statistical Manual for Mental Disorders-5 as the ground truth, diagnostic standard

  Through study completion, on average 2 weeks

Secondary Outcomes (3)

• Proportion of Indeterminate Outputs

  Through study completion, on average 2 weeks.

• Sensitivity and Specificity of the Kintsugi Voice Device with Patient Health Questionnaire-9 Ground Truth

  Through study completion, on average 2 weeks

• Sensitivity and Specificity of the Kintsugi Voice Device with Generalized Anxiety Disorder-7 Ground Truth

  Through study completion, on average 2 weeks

Study Arms (2)

Instruments Followed By SCID

Participants will complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 instruments virtually. Participants will then complete a video recorded virtual Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-5.

Diagnostic Test: Kintsugi Voice Device

SCID Followed By Instruments

Participants will complete a video recorded virtual Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-5. Participants will then complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 instruments virtually.

Diagnostic Test: Kintsugi Voice Device

Interventions

Kintsugi Voice Device DIAGNOSTIC_TEST

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.

Instruments Followed By SCID; SCID Followed By Instruments

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

Adults aged 22 years of age and older at the time of consent who meet all study inclusion and exclusion criteria.

You may qualify if:

• Subjects greater than or equal to 22 years of age at the time of informed consent
• Participants must be able to read, understand, and sign the Informed Consent Form
• Access to a laptop, smartphone, tablet, or other Device with a functioning microphone
• Participants must be willing to be videotaped 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
• The participant must reside within the state of California

You may not qualify if:

• Any impairment that would prevent participants from completing an online survey and/or engage in clinician assessment interviews (e.g., visual impairment, motor impairment, hearing impairment, acute intoxication)
• Any known history of neurodegenerative or Central Nervous System disorders
• Any known history of schizophrenia, psychosis, or severe cognitive deficits
• Any known presence of disorders that may lead to false signal of depression or anxiety including Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Parkinson's Disease, Stroke, Traumatic Brain Injury
• Presence of voice disorders that may impact vocal cords such as acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia
• Any known history of vocal cord injury or cerebrovascular accident or head trauma with residual dysarthria in the past year
• Past or active heavy smokers if there is impact on the vocal cords
• Any known history of congenital deafness
• Subjects who do not speak English
• Subjects who do not live in the United States
• Subjects who have previously participated in any Kintsugi-sponsored study

Sponsors & Collaborators

• Kintsugi Mindful Wellness, Inc.: lead
• Vituity: collaborator

Study Sites (1)

Kintsugi Mindful Wellness, Inc.

Berkeley, California, 94705, United States

Location

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MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being; Disease

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Grace Chang, MBA

  Kintsugi Mindful Wellness, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 26, 2022
• Study Start: September 23, 2022
• Primary Completion: July 5, 2023
• Study Completion: July 5, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)