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Clinical Trials/NCT04851912
NCT04851912
Active, not recruiting
Not Applicable

Preclinical Development of a Speech-based Digital Biomarker for Psychiatric Disease

Winterlight Labs1 site in 1 country200 target enrollmentApril 27, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Speech
Sponsor
Winterlight Labs
Enrollment
200
Locations
1
Primary Endpoint
Speech recordings
Status
Active, not recruiting
Last Updated
3 years ago

Overview

Brief Summary

The general objectives of this study are to build a proof-of-concept, speech-based, digital biomarker for identifying the presence and tracking the severity of psychiatric disease.

Detailed Description

The purpose of this study is to gather longitudinal data to examine how speech features and symptoms change over different intervals of time and the reliability of repeated, high frequency test administration. Participants will complete a variety of speech and language tasks using the Winterlight Assessment (iOS app) everyday for 30 days. The following is the list of assessments that participants will complete; 1) Daily assessment of mood, 2) Winterlight assessment which contains a series of verbal response tasks where participants are recorded through a tablet app, and 3) Clinical assessments.

Registry
clinicaltrials.gov
Start Date
April 27, 2021
End Date
December 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Winterlight Labs
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male and Female adults aged 18 to
  • English as a first language, or English as a second language with conversational proficiency.
  • Own an iOS device (iPhone or iPad) and willing to install the study app.
  • A reliable (cellular or WiFi) home internet connection and accessible email address

Exclusion Criteria

  • Residence outside of Canada or the United States.
  • Clinically significant vision impairment (corrected vision is acceptable).
  • Clinically significant hearing impairment (use of hearing aids is acceptable)

Outcomes

Primary Outcomes

Speech recordings

Time Frame: Everyday for 30 business days until study completion, about 2 years

500+ features to be extracted from each recording

Secondary Outcomes

  • Depression scores(Everyday for 30 business days until study completion, about 2 years)

Study Sites (1)

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