Clinical trial NCT06809907: Kintsugi Voice Device Pivotal Study
Official title: Kintsugi Voice Device SCID-5 Pivotal Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depression
Depression Moderate
Depression Severe
Depression Mild
Lead sponsor: Kintsugi Mindful Wellness, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kolby Walker, DO
name: Sonar Strategies
name: Brittany Kimble
First posted: 2025-02-05
Enrollment: 1000
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: This study will enroll up to 1000 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.

Brief summary: A prospective, single arm, non-randomized, pivotal 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-RV) for up to 1000 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


Eligibility criteria: Inclusion Criteria:

Age \>22 at the time of informed consent Self-reported disruption to activities of daily living (e.g. missed scheduled healthcare appointments, unable to concentrate on tasks like reading, working, or completing daily activities, or difficult completing activities such as exercise, diet, or recreation) 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 Functional English capacity in the home environment Availability for the duration of the study Resides in the United States at the time of consent and during completion of study

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Exclusion Criteria:

* Participants with at least one of the following conditions will be excluded:

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

Primary outcomes:
measure: 1. Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5
timeFrame: Day 1
Secondary outcomes:
measure: Adjudicated Samples Sensitivity and Specificity
timeFrame: Day 1
measure: PPV and NPV Evaluation
timeFrame: Day 1
measure: Subgroup Analysis (Sensitivity and Specificity)
timeFrame: Day 1
measure: Indeterminate Result Analysis
timeFrame: Day 1
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Kintsugi (Decentralized, Virtual Study)
state: California
Study officials:
References: