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Improving Real-time COVID-19 Monitoring Through Smartphone Voice Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04582331
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
Sonde Health

Brief 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.

Condition or disease Intervention/treatment
Covid19 Other: Smartphone-based voice and self-reported symptom collection

Detailed Description:
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

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Real-time COVID-19 Monitoring Through Smartphone Voice Analysis
Actual Study Start Date : September 10, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Group/Cohort Intervention/treatment
COVID-19 positive
Patients with suspected COVID-19 based on presence of at least one newly emerged relevant symptom that has emerged at most 10 days prior to enrollment. COVID-19 positive status is confirmed by diagnostic testing and clinical diagnosis.
Other: Smartphone-based voice and self-reported symptom collection
Voice samples and COVID-19 symptom inventories will be collected on participant smartphone devices. No outcomes or feedback is provided on acquired data during trial conduct but will be used for confirmatory data analysis post study

COVID-19 negative, symptomatic
Patients with suspected COVID-19 based on presence of at least one newly emerged relevant symptom that has emerged at most 10 days prior to enrollment. COVID-19 negative status is confirmed by diagnostic testing and clinical diagnosis.
Other: Smartphone-based voice and self-reported symptom collection
Voice samples and COVID-19 symptom inventories will be collected on participant smartphone devices. No outcomes or feedback is provided on acquired data during trial conduct but will be used for confirmatory data analysis post study

Normal Healthy Volunteers
Asymptomatic healthy participants recruited from hospital staff or co-living family members, or co-living family member of a COVID-19 positive study participant.
Other: Smartphone-based voice and self-reported symptom collection
Voice samples and COVID-19 symptom inventories will be collected on participant smartphone devices. No outcomes or feedback is provided on acquired data during trial conduct but will be used for confirmatory data analysis post study




Primary Outcome Measures :
  1. Vocal biomarker performance in COVID-19 positive vs. healthy controls [ Time Frame: 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


Secondary Outcome Measures :
  1. Vocal biomarker vs. symptom burden correlation in COVID-19 positive [ Time Frame: Pooled across study Days 1-14 ]
    Mean and 90% confidence interval of the correlation coefficient distribution between RRVB-based scores and self-reported respiratory symptom burden pooled across study days within individual COVID-19 patients

  2. Vocal biomarker performance in COVID-19 positive vs. COVID-19 negative symptomatic [ Time Frame: Day 1 of enrollment ]
    Sensitivity, Specificity and Diagnostic Odds Ratio of RRVB, either alone or in combination with a symptom inventory, to discriminate COVID-19 positive vs. symptomatic COVID-19 negative patients on Day 1



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting with suspected COVID-19 with mild or severe disease severity.
Criteria

Inclusion Criteria:

  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:

  8. Confirmed or suspected COVID-19 infection with mild or severe illness severity at screening on Day 1
  9. 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
  10. COVID-19 viral test ordered at the study site within at most 5 days prior to or on Day 1

    For healthy volunteers:

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

Exclusion Criteria:

  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:

  5. History of positive COVID-19 viral or serologic test result any time prior to enrollment
  6. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582331


Contacts
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Contact: Erik Larsen, PhD +1 (857) 869-9683 elarsen@sondehealth.com
Contact: Rebecca Shorin, BA +1 (267) 471-6216 rshorin@sondehealth.com

Locations
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United States, California
UC San Diego Medical Center Not yet recruiting
San Diego, California, United States, 92103
Contact: Edward Castillo, PhD       emcastillo@health.ucsd.edu   
Principal Investigator: James Killeen, MD         
United States, Massachusetts
Brigham & Woman's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Robert Fowler       Robert.Fowler@childrens.harvard.edu   
Principal Investigator: Ahmet Uluer, DO         
United States, New York
Montefiore Medical Center Recruiting
New York, New York, United States, 10467
Contact: Savneet Kaur    718-920-4321    savneet.kaur@einsteinmed.org   
Principal Investigator: Sunit Jariwala, MD         
India
Deenanath Mangeshkar Hospital & Research Centre Recruiting
Pune, India
Contact: Hrishikesh Rangnekar       dr.rangnekar@gmail.com   
Principal Investigator: Bharat Purandare, MD         
Sponsors and Collaborators
Sonde Health
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Responsible Party: Sonde Health
ClinicalTrials.gov Identifier: NCT04582331    
Other Study ID Numbers: SH2020.COV01
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sonde Health:
Respiratory disease
Respiratory infection
Vocal biomarkers
Digital health
Symptom monitoring