NCT04851912

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

April 27, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

2.6 years

First QC Date

April 12, 2021

Last Update Submit

September 24, 2022

Conditions

SpeechPsychiatric DisorderLanguage

Outcome Measures

Primary Outcomes (1)

  • Speech recordings

    500+ features to be extracted from each recording

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

Secondary Outcomes (1)

  • Depression scores

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

Study Arms (1)

General

Participants with or without psychiatric disorders

Other: Winterlight Apps

Interventions

Winterlight AppsOTHER

Longitudinal speech recordings

General

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Anyone who does not have hearing or vision impairment.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winterlight Labs

Toronto, Ontario, M4Y 1V8, Canada

Location

MeSH Terms

Conditions

SpeechMental DisordersLanguage

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Study Officials

  • Jessica Robin, PhD

    Clinical Research Director, Winterlight Labs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 21, 2021

Study Start

April 27, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

September 27, 2022

Record last verified: 2022-09

Locations

CA(1)