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Completed

NCT Number: NCT05554042

Kintsugi Voice Device Study

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.

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Disease Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kintsugi Mindful Wellness, Inc.

Berkeley, California, 94705, United States

About this study

This is a prospective study of up to 100 subjects, ages >22 years of age.

The study is striving for a 50%/50% split of subjects who have depression and/or anxiety and subjects who do not have depression and/or anxiety.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Through study completion, on average 2 weeks

    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

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

    Time frame: Through study completion, on average 2 weeks

    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

Secondary outcomes

  1. Proportion of Indeterminate Outputs

    Time frame: Through study completion, on average 2 weeks.

    Measure the proportion of participants who complete the study and the device output is Indeterminate.

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

    Time frame: Through study completion, on average 2 weeks

    Discriminating the presence of a significant depressive episode against the Patient Health Questionnaire-9 as the ground truth.

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

    Time frame: Through study completion, on average 2 weeks

    Discriminating the presence of a significant anxiety state against the Generalized Anxiety Disorder-7 as the ground truth.

Sponsors and collaborators

Lead sponsor

Kintsugi Mindful Wellness, Inc.

Industry

Collaborators

  • Vituity

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 26, 2022
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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