Kintsugi Voice Device Pilot Study

Status unconfirmed

Conditions studied: Depression, Depression Moderate, Depression Severe, Depression Mild

In brief

A prospective, single arm, non-randomized, pilot 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-CT) for up to 500 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.

Key facts

Study ID

NCT06374056

Run by

Kintsugi Mindful Wellness, Inc.

People needed

500

Starts

2024-03-22

Expected to finish

2025-07-22

Last updated by the study team

2024-10-08

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age >22 at the time of informed consent
• 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
• Fluency in English
• Availability for the duration of the study
• Resides in the United States at the time of consent and during completion of study
• Contributes to the approximately 50/50 depressed/healthy study population distribution

You may not qualify if…

• 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.

Where it is running

• Kintsugi Mindful Wellness Inc. — Berkeley, California, United States

Full record on ClinicalTrials.gov

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