Kintsugi Voice Device Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity of the Kintsugi Voice Device for a Significant Anxiety State
研究概览
简要总结
The Kintsugi Voice Device Pilot Study is a two arm pilot diagnostic accuracy study. Eligible enrolled participants will complete the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) instruments, as well as complete a remote video-recorded Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-5 (SCID) with a trained psychiatrist.
This study seeks to evaluate the ability of the Device to aid clinical assessment for depression and anxiety by comparing its output with the established diagnostic standard consisting of a diagnosis made by a specialist clinician based on DSM-5 criteria.
The order of the assessments will be randomized. Audio captured during the SCID interview will be inputted into a machine learning model to determine the diagnostic accuracy of the Kintsugi Voice Device.
详细描述
This is a prospective study of up to 100 subjects, ages >22 years of age.
The study is striving for a 50%/50% split of subjects who have depression and/or anxiety and subjects who do not have depression and/or anxiety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects greater than or equal to 22 years of age at the time of informed consent
- •Participants must be able to read, understand, and sign the Informed Consent Form
- •Access to a laptop, smartphone, tablet, or other Device with a functioning microphone
- •Participants must be willing to be videotaped 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
- •The participant must reside within the state of California
排除标准
- •Any impairment that would prevent participants from completing an online survey and/or engage in clinician assessment interviews (e.g., visual impairment, motor impairment, hearing impairment, acute intoxication)
- •Any known history of neurodegenerative or Central Nervous System disorders
- •Any known history of schizophrenia, psychosis, or severe cognitive deficits
- •Any known presence of disorders that may lead to false signal of depression or anxiety including Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Parkinson's Disease, Stroke, Traumatic Brain Injury
- •Presence of voice disorders that may impact vocal cords such as acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia
- •Any known history of vocal cord injury or cerebrovascular accident or head trauma with residual dysarthria in the past year
- •Past or active heavy smokers if there is impact on the vocal cords
- •Any known history of congenital deafness
- •Subjects who do not speak English
- •Subjects who do not live in the United States
- •Subjects who have previously participated in any Kintsugi-sponsored study
结局指标
主要结局
Sensitivity and Specificity of the Kintsugi Voice Device for a Significant Anxiety State
时间窗: Through study completion, on average 2 weeks
Discriminates the presence of a significant anxiety state using the Structure Clinical Interview for the Diagnostic Statistical Manual for Mental Disorders-5 as the ground truth, diagnostic standard
Sensitivity and Specificity of the Kintsugi Voice Device for a Significant Depressive Episode
时间窗: Through study completion, on average 2 weeks
Discriminates the presence of a significant depressive episode using the Structure Clinical Interview for the Diagnostic Statistical Manual for Mental Disorders-5 as the ground truth, diagnostic standard
次要结局
- Sensitivity and Specificity of the Kintsugi Voice Device with Generalized Anxiety Disorder-7 Ground Truth(Through study completion, on average 2 weeks)
- Proportion of Indeterminate Outputs(Through study completion, on average 2 weeks.)
- Sensitivity and Specificity of the Kintsugi Voice Device with Patient Health Questionnaire-9 Ground Truth(Through study completion, on average 2 weeks)