Cognoa ASD Diagnostic Device - Data Collection Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Cognoa, Inc.
- 试验地点
- 1
- 主要终点
- Positive and negative predictive value of ASD Dx in relation to clinician diagnostic evaluation
研究概览
简要总结
The primary objective of this study is to collect data to ascertain the PPV and NPV of the current version of the Cognoa diagnostic device. A secondary objective is to collect data, in the form of additional questions, in order to train new algorithms related to children's developmental and behavioral conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Participants, care providers, and diagnostic clinicians are blinded to the diagnostic output of the ASD diagnostic device
入排标准
- 年龄范围
- 18 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 months of age and < 72 months of age
- •Functional English capability in the home environment
- •Documented parental and/or clinician concern for developmental delay
- •Participants must have a smartphone capable of downloading the Cognoa App (Cognoa supports iOS 10.0 and up, Android 6.0 and up)
排除标准
- •Children with suspected auditory or visual hallucinations or with prior diagnosis of childhood onset schizophrenia.
- •Children with known sensory impairment such as deafness or blindness
- •Children with known physical impairment affecting their ability to use their hands
- •Children with major dysmorphic features or prenatal exposure to teratogens (such as fetal alcohol syndrome)
- •Children with history or diagnosis of genetic conditions (such as Rett's syndrome or fragile X)
- •Children with microcephaly
- •Children with history or prior diagnosis of epilepsy or seizures
- •Children with history of or suspected neglect
- •Children with history of brain defect, injury or insult requiring interventions such as surgery or chronic medication
- •Children whose age on the date of enrollment is outside the target age range
- •Children who have been previously enrolled in any Cognoa clinical study or survey
- •Children whose medical records had been included in any internal Cognoa training or validation sets
研究组 & 干预措施
ASD Diagnostic Device
The ASD Diagnostic Device is a machine learning algorithm-based software as a medical device that is incorporated into a parent/caregiver-facing mobile application, the "Cognoa App", used outside of a clinical setting
干预措施: ASD Diagnostic Device (Diagnostic Test)
结局指标
主要结局
Positive and negative predictive value of ASD Dx in relation to clinician diagnostic evaluation
时间窗: approximately one month
次要结局
未报告次要终点