Kintsugi Voice Device Pivotal Study

Официальное название

Kintsugi Voice Device SCID-5 Pivotal Study

Обзор

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

Вмешательства

• Устройство 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

Первичные конечные точки

• 1. Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5 [Срок оценки: Day 1]

Вторичные конечные точки (4)

• Adjudicated Samples Sensitivity and Specificity [Срок оценки: Day 1]
• PPV and NPV Evaluation [Срок оценки: Day 1]
• Subgroup Analysis (Sensitivity and Specificity) [Срок оценки: Day 1]
• Indeterminate Result Analysis [Срок оценки: Day 1]

Критерии участия

Критерии включения

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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Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Kintsugi (Decentralized, Virtual Study) — Berkeley

Идентификаторы

NCT: NCT06809907 · 20245287

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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