Speech-based Digital Biomarker for Psychiatric Disease

Active, not recruiting

• Conditions: Language; Psychiatric Disorder; Speech
• Interventions: Other: Winterlight Apps

• Registration Number: NCT04851912
• Lead Sponsor: Winterlight Labs

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.

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-21
• Study Start: 2021-04-27
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-24
• Last Update Posted: 2022-09-27
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Male and Female adults aged 18 to 95.
• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General	Winterlight Apps	Participants with or without psychiatric disorders

Primary Outcome Measures

Name	Time	Method
Speech recordings	Everyday for 30 business days until study completion, about 2 years	500+ features to be extracted from each recording

Secondary Outcome Measures

Name	Time	Method
Depression scores	Everyday for 30 business days until study completion, about 2 years	Depression and depression like scores to be collected through surveys

Trial Locations

Locations (1)

Winterlight Labs; 🇨🇦 Toronto, Ontario, Canada