Improving Real-time COVID-19 Monitoring Through Smartphone Voice Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Vocal biomarker performance in COVID-19 positive vs. healthy controls
研究概览
简要总结
This is a confirmatory study that seeks to examine whether respiratory-responsive vocal biomarkers have potential to respond to COVID-19 infection status and respiratory symptom severity. Patients with suspected COVID-19 and healthy controls will submit daily voice samples and symptom inventories on their personal smartphone devices for 14 days.
详细描述
This is an observational study examining the potential to use voice analysis to aid in the identification of COVID-19 and as an aid to monitoring of respiratory symptoms of COVID-19. Patients with suspected COVID-19 and healthy controls will be enrolled and use their own smartphone device to provide daily voice samples and symptom inventories. This study seeks to confirm and extend findings from preliminary data from patients with asthma, COPD and cough that has indicated the potential of respiratory responsive vocal biomarkers (RRVB) to respond to respiratory diagnoses and symptom severity. The same RRVB will be examined to confirm whether this potential generalizes to respiratory symptoms associated with COVID-19
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Own an eligible smartphone (iOS or Android) that is able to download and run the Sonde Health app (access to smartphone provided by parent or legal guardian of participants under the age 18 is allowed)
- •Willing to sign up for a Sonde app account
- •Agreement with the subject consent information presented on the Sonde app. In case of adolescent subjects, agreement with subject consent information provided by a parent or legal guardian
- •Stated willingness and ability to comply with all study procedures for the duration of the study
- •Male or female, aged 12 or above (including adults)
- •Able to read and speak English or Spanish (required to follow app instructions and provide correct voice elicitations)
- •Pregnant women are allowed to participate
- •For suspected COVID-19 patients:
- •Confirmed or suspected COVID-19 infection with mild or severe illness severity at screening on Day 1
- •Suspected COVID-19 includes patients having at least one of the following symptoms that are present at most 10 days prior to enrollment:
- •Fever (>37.5 C/ 99.5 F)
- •Shortness of breath
- •Sore throat
- •Loss of taste/ ageusia
- •COVID-19 viral test ordered at the study site within at most 5 days prior to or on Day 1
- •For healthy volunteers:
- •Hospital staff or co-living family members, or co-living family member of a COVID-19 positive patient that is enrolled in this study
- •Age 12 and above
排除标准
- •Difficulties with speech production
- •Difficulties reading or responding to instructions and questions on a smartphone screen
- •Critical COVID-19 illness severity at screening on Day 1
- •Other critical health condition where study participation would place unreasonable burden or risk on the patient as determined by the study site principal investigator
- •For healthy volunteers:
- •History of positive COVID-19 viral or serologic test result any time prior to enrollment
- •Any hospital staff that is a member of the study team, and staff in the pulmonary and infectious disease departments of the participating institution, or any of their co-living family members
结局指标
主要结局
Vocal biomarker performance in COVID-19 positive vs. healthy controls
时间窗: Day 1 of study enrollment
Sensitivity, Specificity and Diagnostic Odds Ratio of RRVB, either alone or in combination with a symptom inventory, to identify COVID-19 positive patients vs. asymptomatic healthy controls
次要结局
- Vocal biomarker vs. symptom burden correlation in COVID-19 positive(Pooled across study Days 1-14)
- Vocal biomarker performance in COVID-19 positive vs. COVID-19 negative symptomatic(Day 1 of enrollment)