Wearable Suicidal Early Warning System for Adolescents | NCT03030924

Studies
Wearable Suicidal Early Warning System for Adolescents

NCT03030924

Sponsor

Oregon Health and Science University

Status

Active, not recruiting

Last Update Posted

Aug 20, 2025Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Suicide
Adolescent Behavior

Interventions

Solace

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5K12HL133115	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 18, 2017Actual

Primary Completion Date

Jun 30, 2025Actual

Completion Date

Jun 1, 2026Estimated

First Submitted Date

Jan 21, 2017

First Submission Date that Met QC Criteria

Jan 21, 2017

First Posted Date

Jan 25, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2025

Last Update Posted Date

Aug 20, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. David Sheridan, Assistant Professor of Emergency Medicine/Pediatrics, Oregon Health and Science UniversityPrincipal Investigator

Lead Sponsor

Oregon Health and Science UniversityOTHER

Collaborators

Name	Class
National Institute of Mental Health (NIMH)	NIH
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is prospectively enrolling a cohort of adolescent patients who present to the Emergency Department and an inpatient psychiatric adolescent unit with acute suicidality.

Detailed Description

This study is prospectively enrolling a cohort of adolescent patients who present to the Emergency Department with acute suicidality or are admitted to an inpatient psychiatric adolescent unit. The plan is to monitor basic physiologic parameters to assess for trends associated with suicidality noninvasively in an objective manner beyond subjective questionnaires currently available. Upon discharge they will be sent home with a noninvasive monitor to track physiologic parameters.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Name	Type	Description	Arm Group Labels	Other Names
Solace	Device	Noninvasive physiologic monitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart Rate Variability		1 week

Secondary Outcomes

Measure	Description	Time Frame
Gender		At enrollment
Age	in Years	at enrollment
Columbia Suicide Severity Score

Other Outcomes

Measure	Description	Time Frame
past Medical History		At enrollment
Medications	Daily medications	At enrollment and daily for one week after discharge

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute suicidality
consenting individual present in the emergency department

Exclusion Criteria:

medical admission for an ingestion or other reason

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Adolescents presenting with acute suicidal thoughts or attempts in the pediatric emergency department (13-19 years of age).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Sheridan, MD	Oregon Health and Science University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OHSU		Portland	Oregon	97239	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35100750	Derived	Sheridan DC, Lin A. Emergency Department Adolescent Suicidality: A Pilot Study to Determine How Common Actual Attempts Are. Pediatr Emerg Care. 2022 Feb 1;38(2):e458-e461. doi: 10.1097/PEC.0000000000002629.
33017533	Derived	Sheridan DC, Dehart R, Lin A, Sabbaj M, Baker SD. Heart Rate Variability Analysis: How Much Artifact Can We Remove? Psychiatry Investig. 2020 Sep;17(9):960-965. doi: 10.30773/pi.2020.0168. Epub 2020 Sep 18.

ID	Term
D016728	Self-Injurious Behavior
D001526	Behavioral Symptoms
D001519	Behavior