Vocal Feature Analysis Algorithm

  • STATUS
    Recruiting
  • participants needed
    400
  • sponsor
    Soniphi LLC
Send
Updated on 16 February 2024
See if I qualify
covid-19

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.

Details
Condition Covid 19
Age 18years - 100years
Treatment Device used to record voice for screening
Clinical Study IdentifierNCT04418544
SponsorSoniphi LLC
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

covid-19

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.