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Vocal Feature Analysis Algorithm for COVID-19 Detection

NCT ID: NCT04418544

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control

Do not test positive for COVID

Device used to record voice for screening

Intervention Type DEVICE

voice recording

COVID-19 Positive

Test positive for Covid using swab test.

Device used to record voice for screening

Intervention Type DEVICE

voice recording

Interventions

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Device used to record voice for screening

voice recording

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UserWise, LLC

INDUSTRY

Sponsor Role collaborator

Soniphi LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Steady, MD

Role: PRINCIPAL_INVESTIGATOR

Soniphi LLC

Locations

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Soniphi

Sebastopol, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stephen Steady, MD

Role: CONTACT

[email protected]
(415) 309-3242

Ari Levitt, MD

Role: CONTACT

[email protected]
(206) 731-9172

Facility Contacts

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M Sanderson, BS

Role: primary

[email protected]

Other Identifiers

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002 Soniphi

Identifier Type: -

Identifier Source: org_study_id