Recruiting

Observational Study

Sponsor:

Oregon Health and Science University

Code:

NCT06400810

Conditions

Suicide

Mental Health Issue

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

Analog Devices Inc.

Study Details

Brief summary:

The central hypothesis is that biometric data can continuously monitor and allow for early identification/intervention of escalating suicidal symptoms. The rationale is that improved outpatient monitoring through wearable technology can create a more objective platform to provide the ability to identify a worsening condition and utilize patient-specific just-in-time therapeutics developed with mental health providers for suicidal adolescents.

Conditions

Suicide

Mental Health Issue

Study ID

NCT06400810

Start date

Jun 15, 2023

Status verified date

Aug, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jun 30, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • subjects aged 13-17 years
  • presenting to the ED or inpatient psychiatric unit with a chief complaint of acute suicidality or attempt.

Exclusion Criteria:

  • acutely agitated patients per the treating physician
  • adolescents who are not medically cleared from a suicide attempt
  • no legally authorized representative available to provide consent
  • parental report of significant developmental delay or autism diagnosis
  • prisoners
  • non-English speaking.

Study Design

Enrollment

144 participants

Anticipated

Interventions and Outcome Measures

Arms

Suicidal Adolescent

he study will enroll subjects aged 13-17 years admitted with a chief complaint of acute suicidality or attempt. Patients will undergo physiologic and biometric monitoring in the hospital with a wrist-wearable device and chest wall ECG leads. They will undergo serial assessment four times daily to gather data regarding their activities, affect, and suicidality.

Interventions

Analog Devices Inc.

Wearable wrist device that collects Photoplethysmography, accelerometer data among other parameters.

Primary outcome measure

  • Heart rate variability and Suicidality [ Time Frame: Four times daily up to one week ]
  • Heart rate variability and Suicidality [ Time Frame: Four times daily up to one week ]

Central Contacts and Locations

Central contacts

David Sheridan, MD

503-494-1691sheridda@ohsu.edu

Locations

OHSU

Recruiting

Portland, Oregon, United States, 97239

Contacts

David C Sheridan, MD

5034941691sheridda@Ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Aug 14, 2025

Last verified

Aug, 2025

Keywords

  • adolescent
  • emergency

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-08-14.