Clinical trial NCT05554042: Kintsugi Voice Device Study
Official title: Kintsugi Voice Device Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression, Anxiety
Keywords: mental health
depression
anxiety
remote research
artificial intelligence
diagnostic
Lead sponsor: Kintsugi Mindful Wellness, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Vituity
First posted: 2022-09-26
Enrollment: 132
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and Specificity of the Kintsugi Voice Device for a Significant Depressive Episode
timeFrame: Through study completion, on average 2 weeks
measure: Sensitivity and Specificity of the Kintsugi Voice Device for a Significant Anxiety State
timeFrame: Through study completion, on average 2 weeks
Secondary outcomes:
measure: Proportion of Indeterminate Outputs
timeFrame: Through study completion, on average 2 weeks.
measure: Sensitivity and Specificity of the Kintsugi Voice Device with Patient Health Questionnaire-9 Ground Truth
timeFrame: Through study completion, on average 2 weeks
measure: Sensitivity and Specificity of the Kintsugi Voice Device with Generalized Anxiety Disorder-7 Ground Truth
timeFrame: Through study completion, on average 2 weeks
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Kintsugi Mindful Wellness, Inc.
state: California
Study officials:
affiliation: Kintsugi Mindful Wellness, Inc.
name: Grace Chang, MBA
role: PRINCIPAL_INVESTIGATOR
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