SuicideNCT03030924
Wearable Suicidal Early Warning System for Adolescents
An observational study of Suicide and Adolescent Behavior, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Suicide, Adolescent Behavior
- What is being tested?
- Solace
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2017to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Child, Adult
Study population: Adolescents presenting with acute suicidal thoughts or attempts in the pediatric emergency department (13-19 years of age).
Who may be able to join
- acute suicidality
- consenting individual present in the emergency department
Who cannot join
- medical admission for an ingestion or other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiologic Parameters for Monitoring Adolescent Suicidality
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.
Read the 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.
- Conditions
- Suicide, Adolescent Behavior
- Being tested
- Solace
- Keywords
- suicide
- Medical subject headings
- Suicide, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolaceDevice
Noninvasive physiologic monitor
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
Measured: 1 week
Secondary outcomes (5)
Gender
Measured: At enrollment
Age
in Years
Measured: at enrollment
Columbia Suicide Severity Score
Numerical based on severity
Measured: 1 week
PHQ-9 Depression Scale
Numerical based on severity
Measured: 1 week
Motion
As detected by an accelerometer in Hz
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start18 Sep 2017
- Primary completion30 Jun 2025
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Dr. David Sheridan, Oregon Health and Science University
- Investigators
- David Sheridan, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030924
- Sponsor's protocol ID
- STUDY00016409
- Other IDs
- 5K12HL133115
- Status last verified
- Oct 2026
- First submitted
- 21 Jan 2017
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35100750Sheridan 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.
PubMed 33017533
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Parameters for Monitoring Adolescent Suicidality
- ClinicalTrials.gov ID
- NCT03030924
- Acronym / sponsor ID
- STUDY00016409
- Conditions
- Suicide, Adolescent Behavior
- Keywords
- suicide
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Adolescents presenting with acute suicidal thoughts or attempts in the pediatric emergency department (13-19 years of age).
Key inclusion criteria (2 listed)
- acute suicidality
- consenting individual present in the emergency department
Key exclusion criteria (1 listed)
- medical admission for an ingestion or other reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SolaceNoninvasive physiologic monitor | Device | – |
Primary outcome
Heart Rate Variability
Time frame: 1 week
5 secondary outcomes
Gender
Time frame: At enrollment
Age
Time frame: at enrollment
Columbia Suicide Severity Score
Time frame: 1 week
PHQ-9 Depression Scale
Time frame: 1 week
Motion
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 35100750Sheridan 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.
- Derived from this study: PubMed 33017533Sheridan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Sheridan, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide and Adolescent Behavior, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03030924, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.