Speech-based Digital Biomarker for Psychiatric Disease

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Psychiatric Disorder; Language; Speech
• Intervention / Treatment: Other: Winterlight Apps

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4Y 1V8
      • Winterlight Labs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Anyone who does not have hearing or vision impairment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General; Participants with or without psychiatric disorders	Other: Winterlight Apps; Longitudinal speech recordings

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression scores	Depression and depression like scores to be collected through surveys	Everyday for 30 business days until study completion, about 2 years

Collaborators and Investigators

• Sponsor: Winterlight Labs
• Investigators: Principal Investigator: Jessica Robin, PhD, Clinical Research Director, Winterlight Labs

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 24, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Mental Disorders
• Other Study ID Numbers: WLL-PRO-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No