Kintsugi Voice Device Study

Kintsugi Mindful Wellness

Status: Completed

Conditions: Depression, Anxiety

Treatments: Diagnostic Test: Kintsugi Voice Device

Study type: Observational

Funder types: Industry; Other

Identifier

NCT05554042

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

132 participants in 2 patient groups

Instruments Followed By SCID

Description:

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.

Treatment:

Diagnostic Test: Kintsugi Voice Device

SCID Followed By Instruments

Description:

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.

Treatment:

Diagnostic Test: Kintsugi Voice Device