Wearable Suicidal Early Warning System for Adolescents

Suicide Clinical Trial

Official title:

Physiologic Parameters for Monitoring Adolescent Suicidality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03030924
• Other study ID #: STUDY00016409
• Secondary ID: 5K12HL133115
• Status: Recruiting
• Start date: September 18, 2017
• Est. completion date: October 1, 2023

Study information

• Verified date: September 2022
• Source: Oregon Health and Science University
• Contact: David Sheridan, MD
• Phone: 5034941691
• Email: sheridda[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 1, 2023
• Est. primary completion date: July 1, 2023
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

Inclusion Criteria:

• acute suicidality

• consenting individual present in the emergency department

Exclusion Criteria:

• medical admission for an ingestion or other reason

Related Conditions & MeSH terms

• Adolescent Behavior
• Suicide

Intervention

Device:
• Solace
Noninvasive physiologic monitor

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	past Medical History		At enrollment
Other	Medications	Daily medications	At enrollment and daily for one week after discharge
Primary	Heart Rate Variability		1 week
Secondary	Gender		At enrollment
Secondary	Age	in Years	at enrollment
Secondary	Columbia Suicide Severity Score	Numerical based on severity	1 week
Secondary	PHQ-9 Depression Scale	Numerical based on severity	1 week
Secondary	Motion	As detected by an accelerometer in Hz	1 week