Speech-based Digital Biomarker for Psychiatric Disease

Psychiatric Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04851912
• Other study ID #: WLL-PRO-005
• Status: Active, not recruiting
• Start date: April 27, 2021
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: Winterlight Labs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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)

Related Conditions & MeSH terms

• Language
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder
• Speech

Intervention

Other:
• Winterlight Apps
Longitudinal speech recordings

Locations

Country	Name	City	State
Canada	Winterlight Labs	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Winterlight Labs

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech recordings	500+ features to be extracted from each recording	Everyday for 30 business days until study completion, about 2 years
Secondary	Depression scores	Depression and depression like scores to be collected through surveys	Everyday for 30 business days until study completion, about 2 years