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Recruiting

NCT Number: NCT06400810

Proximal Risk for Suicide in Adolescents

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.

Recruiting

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

OHSU

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

David C Sheridan, MD

CONTACT

[email protected]

5034941691

About this study

Suicide rates have exponentially increased, and it is now the 2nd leading cause of death in adolescence, accounting for over 1.2 million annual emergency department (ED) visits. After an ED visit or attempt, up to 20% of adolescents will have a second attempt within 12 months, and almost half will have a repeat ED visit. This proposal's overall objectives are to investigate physiologic parameters and biometric data from wearable technology that is temporally related to suicidal behavior and develop a personalized, predictive tool that can improve outpatient identification of adolescent patients with suicidality before a crisis develops requiring an ED visit. 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. To attain the overall objectives, I will pursue the following specific aims: (i) To evaluate whether HRV, combined with patient-specific risk factors, can be used to detect dynamic changes in suicide severity among a prospective cohort of acutely suicidal adolescents, (ii) To utilize machine learning to determine whether there is a temporal relationship/signature in the raw PPG signal before or immediately after changes in suicide severity reporting combined with patient-specific risk factors to develop a prediction tool for suicidality risk. These aims will be accomplished in three years through a prospective observational study enrolling acutely suicidal adolescents in the ED and an inpatient psychiatric unit. Ultimately, such knowledge can offer unique opportunities for early detection, just-in-time interventions, and support over 1.2 million suicidal adolescents presenting to EDs nationally.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Analog Devices Inc.

Device

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

Other names: Analog

Primary outcomes

  1. Heart rate variability and Suicidality

    Time frame: Four times daily up to one week

    Prediction of Suicidality outcome measured by the Columbia Suicide Severity scale (higher score means more suicidal)

  2. Heart rate variability and Suicidality

    Time frame: Four times daily up to one week

    Prediction of Suicidality outcome measured by the High Frequency Heart Rate Variability Metric (lower score means less parasympathetic response)

Study contacts

Contact information is provided by the study sponsor or research team.

David Sheridan, MD

CONTACT

[email protected]

503-494-1691

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Analog Device, Inc.

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 6, 2024
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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