Vocal Feature Analysis Algorithm for COVID-19 Detection

NCT04418544 | Unknown FDA Device

• 1 other identifier: 002 Soniphi
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity

  compare Sensitivity and Specificity to standard swab test

  6 months

Study Arms (2)

Control

Do not test positive for COVID

Device: Device used to record voice for screening

COVID-19 Positive

Test positive for Covid using swab test.

Device: Device used to record voice for screening

Interventions

Device used to record voice for screening DEVICE

voice recording

COVID-19 Positive; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients being tested for COVID-19.

You may qualify if:

• Male or female, aged \> 18 years
• Provide a valid electronic informed consent form
• Eligible patients are those meeting SOC guidelines for swab tests for COVID-19 and those providing an evaluable sample.
• Stated willingness to provide evidence of their lab test results
• Pregnant or lactating women may participate

You may not qualify if:

• Presence of tracheostomy or past tracheostomy with permanent change to the voice due complications that involved the vocal cords.
• Prior surgery which may influence the vocal cords, e.g., laryngeal, tracheal or esophageal surgery
• Prior head, neck or throat cancer treated with radical neck dissection and/or radiation therapy that may influence the vocal cords
• Treatment with another investigational drug or device within 30 days prior to signing Consent Form

Sponsors & Collaborators

• Soniphi LLC: lead
• UserWise, LLC: collaborator

Study Sites (1)

Soniphi

Sebastopol, California, 95472, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Stephen Steady, MD

  Soniphi LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Steady, MD

CONTACT

(415) 309-3242; slsteady@vivacitashealthcare.com

Ari Levitt, MD

CONTACT

(206) 731-9172; aril@sonaphi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 5, 2020
• Study Start: June 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 30, 2020

Record last verified: 2020-10

Locations

US (1)