Improving Real-time COVID-19 Monitoring Through Smartphone Voice Analysis
Completed
Conditions studied: Covid19
In brief
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.
Key facts
- Study ID
- NCT04582331
- Run by
- Sonde Health
- People needed
- 500
- Starts
- 2020-09-10
- Expected to finish
- 2021-05-12
- Last updated by the study team
- 2021-05-14
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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:
- Cough
- Fever (>37.5 C/ 99.5 F)
- Shortness of breath
- Sore throat
- Diarrhea
- Anosmia
- 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
You may not qualify if…
- 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
Where it is running
- UC San Diego Medical Center — San Diego, California, United States
- Brigham & Woman's Hospital — Boston, Massachusetts, United States
- Montefiore Medical Center — New York, New York, United States
- Deenanath Mangeshkar Hospital & Research Centre — Pune, India
Full record on ClinicalTrials.gov
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