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NCT04418544 Clinical Trial

Vocal Feature Analysis Algorithm for COVID-19 Detection

COVID-19 Clinical Trial

Official title:
Testing of Soniphi Vocal Feature Analysis Algorithm for COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04418544
Other study ID # 002 Soniphi
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date December 2020

Study information
Verified date October 2020
Source Soniphi LLC
Contact Stephen Steady, MD
Phone (415) 309-3242
Email slsteady@vivacitashealthcare.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational, prospective, non-randomized, non-significant risk study collecting voice recordings from subjects who are being tested for COVID-19 by laboratory analysis of specimens obtained by nasal or naso-pharyngeal (NP) swab. Patients record their voices through an app on their mobile phone. Patients and health care providers will be blinded to the swab test results during Phase 2 of the study.

Description:

The primary objective of this observational study is to determine if the Vocal Feature Analysis (VFA) Algorithm developed by Soniphi can screen for the COVID-19 condition from voice recordings. Patients eligible for the study are those being tested for COVID-19 based on molecular diagnostic testing of specimens obtained by nasal or nasopharyngeal swab. No clinical decisions will be based on the recordings. The results of the algorithm analysis will not be made available to the subjects or their healthcare providers during or after the study.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Male or female, aged > 18 years 2. Provide a valid electronic informed consent form 3. Eligible patients are those meeting SOC guidelines for swab tests for COVID-19 and those providing an evaluable sample. 4. Stated willingness to provide evidence of their lab test results 5. Pregnant or lactating women may participate Exclusion Criteria: 1. Presence of tracheostomy or past tracheostomy with permanent change to the voice due complications that involved the vocal cords. 2. Prior surgery which may influence the vocal cords, e.g., laryngeal, tracheal or esophageal surgery 3. Prior head, neck or throat cancer treated with radical neck dissection and/or radiation therapy that may influence the vocal cords 4. Treatment with another investigational drug or device within 30 days prior to signing Consent Form

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Device used to record voice for screening
voice recording

Locations
Country Name City State
United States Soniphi Sebastopol California

Sponsors (2)
Lead Sponsor Collaborator
Soniphi LLC UserWise

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and Specificity compare Sensitivity and Specificity to standard swab test 6 months
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