Recruiting

Vocal Feature Analysis

Sponsor:

Soniphi LLC

Code:

NCT04418544

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Device used to record voice for screening

Study Details

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

Study ID

NCT04418544

Start date

Jun 1, 2020

Status verified date

Oct, 2020

Completion date

Dec, 2020

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Control

Do not test positive for COVID

COVID-19 Positive

Test positive for Covid using swab test.

Interventions

Device used to record voice for screening

voice recording

Primary outcome measure

  • Sensitivity and Specificity [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Stephen Steady, MD

(415) 309-3242slsteady@vivacitashealthcare.com

Ari Levitt, MD

(206) 731-9172aril@sonaphi.com

Locations

Soniphi

Recruiting

Sebastopol, California, United States, 95472

Contacts

M Sanderson, BS

research@soniphi.com

More Information

Sponsor

Soniphi LLC

Last update posted

Oct 30, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Soniphi LLC on 2020-10-30.