Actively Recruiting
Kintsugi Voice Device Pivotal Study
Led by Kintsugi Mindful Wellness, Inc. · Updated on 2025-04-30
1000
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
Sponsors
K
Kintsugi Mindful Wellness, Inc.
Lead Sponsor
K
Kolby Walker, DO
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Kintsugi Voice Device Pivotal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 22 at the time of informed consent
- Self-reported disruption to daily activities (such as missed healthcare appointments or difficulty concentrating on tasks)
- Access to a laptop, smartphone, tablet, or other device with a working microphone and internet access
- Willingness to be video and audio recorded as part of the study
- Willingness to comply with all study procedures and be available for the study duration
- Functional English ability in the home environment
- Resides in the United States at consent and during study completion
You will not qualify if you...
- Any impairment that affects ability to speak or use a computer for surveys or virtual assessments (e.g., visual, motor, or hearing impairments)
- Any history of neurological diseases affecting speech or computer use (e.g., CNS disorders, Multiple Sclerosis, ALS, Parkinson's Disease)
- Any history of stroke, cognitive defects (e.g., dementia, Alzheimer's), or traumatic brain injury
- Presence of voice disorders affecting speech (e.g., laryngitis, vocal cord paralysis, spasmodic dysphonia)
- Past or current heavy smoking (more than 20 cigarettes per day on average)
- Previous participation in any Kintsugi-sponsored study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kintsugi (Decentralized, Virtual Study)
Berkeley, California, United States, 94707
Actively Recruiting
Research Team
D
Dr. Kolby Walker D.O.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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