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Speech-based Digital Biomarker for Psychiatric Disease

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ClinicalTrials.gov Identifier: NCT04851912
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Speech Psychiatric Disorder Language 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preclinical Development of a Speech-based Digital Biomarker for Psychiatric Disease
Actual Study Start Date : April 27, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

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




Primary Outcome Measures :
  1. Speech recordings [ Time Frame: Everyday for 30 weeks until study completion, about 2 years ]
    500+ features to be extracted from each recording


Secondary Outcome Measures :
  1. Depression scores [ Time Frame: Everyday for 30 weeks until study completion, about 2 years ]
    Depression and depression like scores to be collected through surveys



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Anyone who does not have hearing or vision impairment.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851912


Contacts
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Contact: Jessica Robin, PhD 4169490187 jessica@winterlightlabs.com
Contact: Melisa Gumus, MSc 6472674460 melisa@winterlightlabs.com

Locations
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Canada, Ontario
Winterlight Labs Recruiting
Toronto, Ontario, Canada, M4Y 1V8
Contact: Melisa Gumus, MSc         
Sponsors and Collaborators
Winterlight Labs
Investigators
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Principal Investigator: Jessica Robin, PhD Clinical Research Director, Winterlight Labs
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Responsible Party: Winterlight Labs
ClinicalTrials.gov Identifier: NCT04851912    
Other Study ID Numbers: WLL-PRO-005
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mental Disorders
Problem Behavior
Behavioral Symptoms