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Recruiting NCT06809907

Kintsugi Voice Device Pivotal Study

— Observational Depression Depression Moderate Depression Severe Depression Mild

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Kintsugi Voice Device.
Who it may be relevant to
Registry conditions: Depression, Depression Moderate, Depression Severe, Depression Mild. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Kintsugi Voice Device SCID-5 Pivotal Study

Overview

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

Interventions

  • Device Kintsugi Voice Device
    The Kintsugi Voice Device is intended to be used to screen for the presence of voice signals consistent with a current moderate to severe depressive episode in patients aged 22 and older. The device is intended to be used by care providers licensed to screen for depression and in settings where the screening for depression occurs. The device is neither to be used in lieu of a complete patient evaluation nor to supplant any of the clinician's standard assessments for the screening or diagnosis of

Primary outcome measures

  • 1. Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5 [Time frame: Day 1]
Secondary outcome measures (4)
  • Adjudicated Samples Sensitivity and Specificity [Time frame: Day 1]
  • PPV and NPV Evaluation [Time frame: Day 1]
  • Subgroup Analysis (Sensitivity and Specificity) [Time frame: Day 1]
  • Indeterminate Result Analysis [Time frame: Day 1]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Kintsugi (Decentralized, Virtual Study) — Berkeley

Identifiers

NCT: NCT06809907 · 20245287

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗