Vocal Feature Analysis Algorithm for COVID-19 Detection

Testing of Soniphi Vocal Feature Analysis Algorithm for COVID-19

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04418544

Enrollment

400

Registered

2020-06-05

Start date

2020-06-01

Completion date

2020-12-31

Last updated

2020-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Brief 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.

Detailed 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.

Interventions

DEVICEDevice used to record voice for screening

voice recording

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and Specificity	6 months	compare Sensitivity and Specificity to standard swab test

Countries

United States

Contacts

Primary ContactStephen Steady, MD

slsteady@vivacitashealthcare.com(415) 309-3242

Backup ContactAri Levitt, MD

aril@sonaphi.com(206) 731-9172

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026