Summary

Eligibility
for people ages 12 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California and other locations
Dates
study started
estimated completion
Principal Investigator
by James Killeen, MD
Photo of James Killeen
James Killeen

Description

Summary

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.

Details

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

Keywords

Covid19 Respiratory disease Respiratory infection Vocal biomarkers Digital health Symptom monitoring Smartphone-based voice and self-reported symptom collection COVID-19 positive COVID-19 negative, symptomatic

Eligibility

You can join if…

Open to people ages 12 years and up

  1. 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)
  2. Willing to sign up for a Sonde app account
  3. 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
  4. Stated willingness and ability to comply with all study procedures for the duration of the study
  5. Male or female, aged 12 or above (including adults)
  6. Able to read and speak English or Spanish (required to follow app instructions and provide correct voice elicitations)
  7. Pregnant women are allowed to participate

For suspected COVID-19 patients:

  1. Confirmed or suspected COVID-19 infection with mild or severe illness severity at screening on Day 1
  2. Suspected COVID-19 includes patients having at least one of the following symptoms that are present at most 10 days prior to enrollment:
  3. Cough
  4. Fever (>37.5 C/ 99.5 F)
  5. Shortness of breath
  6. Sore throat
  7. Diarrhea
  8. Anosmia
  9. Loss of taste/ ageusia
  10. . COVID-19 viral test ordered at the study site within at most 5 days prior to or on Day 1

For healthy volunteers:

  1. . Hospital staff or co-living family members, or co-living family member of a COVID-19 positive patient that is enrolled in this study
  2. . Age 12 and above

You CAN'T join if...

  1. Difficulties with speech production
  2. Difficulties reading or responding to instructions and questions on a smartphone screen
  3. Critical COVID-19 illness severity at screening on Day 1
  4. 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:

  1. History of positive COVID-19 viral or serologic test result any time prior to enrollment
  2. 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

Locations

  • UC San Diego Medical Center not yet accepting patients
    San Diego California 92103 United States
  • Montefiore Medical Center accepting new patients
    New York New York 10467 United States

Lead Scientist at UCSD

  • James Killeen, MD
    Dr. James Killeen is a UCSD Clinical Professor for both the Emergency Department and Hyperbaric Medicine Department. He is Director of Information Technology Services for the UCSD Emergency Department. Chief Medical Officer for the San Diego Health Connect. He completed his medical school education at USC and training in Louisiana at Charity Hospital in 1999.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sonde Health
ID
NCT04582331
Study Type
Observational
Last Updated