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Wearable Suicidal Early Warning System for Adolescents

Physiologic Parameters for Monitoring Adolescent Suicidality

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03030924
Enrollment
250
Registered
2017-01-25
Start date
2017-09-18
Completion date
2026-06-01
Last updated
2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, Suicide

Keywords

suicide

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.

Interventions

DEVICESolace

Noninvasive physiologic monitor

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Oregon Health and Science University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
13 Years to 19 Years

Inclusion criteria

* acute suicidality * consenting individual present in the emergency department

Exclusion criteria

* medical admission for an ingestion or other reason

Design outcomes

Primary

MeasureTime frame
Heart Rate Variability1 week

Secondary

MeasureTime frameDescription
GenderAt enrollment
Ageat enrollmentin Years
Columbia Suicide Severity Score1 weekNumerical based on severity
PHQ-9 Depression Scale1 weekNumerical based on severity
Motion1 weekAs detected by an accelerometer in Hz

Other

MeasureTime frameDescription
past Medical HistoryAt enrollment
MedicationsAt enrollment and daily for one week after dischargeDaily medications

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026