SpeechNCT04851912
Speech-based Digital Biomarker for Psychiatric Disease
An observational study of Speech and Psychiatric Disorder, run by Winterlight Labs at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Speech, Psychiatric Disorder, Language
- What is being tested?
- Winterlight Apps
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 27 Apr 2021to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Anyone who does not have hearing or vision impairment.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Speech, Psychiatric Disorder, Language
- Being tested
- Winterlight Apps
- Medical subject headings
- Speech, Mental Disorders, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Winterlight AppsOther
Longitudinal speech recordings
| Study group | Role | What they receive |
|---|---|---|
| General | Participants with or without psychiatric disorders Receives: Other: Winterlight Apps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech recordings
500+ features to be extracted from each recording
Measured: Everyday for 30 business days until study completion, about 2 years
Secondary outcomes (1)
Depression scores
Depression and depression like scores to be collected through surveys
Measured: Everyday for 30 business days until study completion, about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start27 Apr 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpeechStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Winterlight Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessica Robin, PhD, Principal investigator, Clinical Research Director, Winterlight Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851912
- Sponsor's protocol ID
- WLL-PRO-005
- Status last verified
- Sep 2022
- First submitted
- 12 Apr 2021
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preclinical Development of a Speech-based Digital Biomarker for Psychiatric Disease
- ClinicalTrials.gov ID
- NCT04851912
- Acronym / sponsor ID
- WLL-PRO-005
- Conditions
- Speech, Psychiatric Disorder, Language
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Winterlight LabsIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General | – | Other: Winterlight AppsParticipants with or without psychiatric disorders |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Anyone who does not have hearing or vision impairment.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Winterlight AppsLongitudinal speech recordings | Other | General |
Primary outcome
Speech recordings
Time frame: Everyday for 30 business days until study completion, about 2 years
500+ features to be extracted from each recording
1 secondary outcome
Depression scores
Time frame: Everyday for 30 business days until study completion, about 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Robin, PhD principal investigator
Clinical Research Director, Winterlight Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Speech and Psychiatric Disorder, run by Winterlight Labs at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech recordings (time frame: Everyday for 30 business days until study completion, about 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.