Suicidal IdeationNCT04744740
In-Home Sleep Monitoring to Detect Suicide Risk in Veterans
An observational study of Suicidal Ideation and Sleep Disturbance, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
This research will assess the ability of nightly objective sleep scheduling and sleep heart rate data to predict variation in suicidal ideation in U.S. military veterans identified as high-risk according to actuarial and/or clinical indicators. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Suicidal Ideation, Sleep Disturbance
- What is being tested?
- in-home sleep recording
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans with PTSD with or without elevated actuarial risk for suicide
Who may be able to join
- PTSD or partial PTSD
- Status on clinical high-risk list and subject to enhanced surveillance by the suicide prevention activity and staff at VAPAHCS (or not)
- Adequate cell phone service and/or wireless wife connectivity in sleeping quarters.
Who cannot join
- Schizophrenia or psychotic disorder, autism-spectrum diagnoses medically unstable
- unable to speak and read English or otherwise incapable of providing informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA Palo Alto Health Care System
Palo Alto, California, 94304
Esther Eng, BA, 650-239-2818, eng@pavir.org
Elaine Staats, BA, 650-239-2803, estaats@pavir.org
About this study
This research will assess the ability of nightly objective sleep scheduling and sleep heart rate data to predict variation in suicidal ideation in U.S. military veterans identified as high-risk according to actuarial and/or clinical indicators. These data will be recorded using one of two low-cost, commercial, zero-burden, mattress actigraphic systems that enable remote, centralized, data access. Participants will be veterans accrued both from the REACH VET and local high-risk lists, a process involving collaboration with the Suicide Prevention Coordinator at the VA Palo Alto HCS. In order to minimize burden, participants will be screened by telephone, consented by mail and telephone, administered a brief admission psychometric interview by telephone, and mailed a sleep sensor system and instructions for its installation in their home. Once sleep data collection has commenced, a trained interviewer will contact the participant by telephone weekly and administer the Columbia-Suicide Severity Rating Scale. Data collection will continue for three months. The study targets a sample of 40 veterans. Longitudinal mixed effects modeling will be employed to determine whether changes in sleep scheduling and sleep heart rate predict changes in suicidal ideation.
Read the detailed description
Suicide is a devastating event that occurs at a very low base rate, rendering detection of acute suicide risk one of the signal challenges in behavioral science. Advancement in the detection of imminent risk requires new modalities of intensive, longitudinal data collection that are both acceptable and scalable. Recent developments in commercial, actigraphic sleep recording systems have opened a new avenue of approach to this challenge, enabling the automated collection and daily review of sleep scheduling and sleep heart rate (HR), both of which have demonstrated associations with suicidality in prior studies. Our team, comprising Drs. Steven Woodward (Director of the Sleep and Psychophysiology Laboratory of the National Center for PTSD), Rebecca Bernert (Director of the Suicide Prevention Center, Stanford University School of Medicine), Christina Khan (Director of the Thrive Clinic, Stanford University School of Medicine), and Wilfred Pigeon (Director of the Center of Excellence in Suicide Prevention, Department of Veterans Affairs) will pursue the following Aims.
AIM 1: To assess, in U.S. military veterans diagnosed with posttraumatic stress disorder (PTSD), whether sleep schedule variability and sleep heart rate, recorded in the home for one month using a low-cost, zero-burden, actigraphic sleep measurement system, can distinguish those who are at elevated actuarial risk for suicide from those who are not.
AIM 2: To assess, in U.S. military veterans diagnosed with PTSD, whether elevated sleep schedule variability and elevated sleep heart rates can predict increased suicidal ideation over a clinically-relevant surveillance period of two months.
The proposal is founded on observational and epidemiological studies supporting associations between sleep disturbance, basal heart rate and suicidality, including important contributions from Co-Is Bernert and Pigeon (1-12). Also supportive of the proposal are new observations from a sample of 71 U.S. Military veterans with deployment-related PTSD studied by the PI during inpatient PTSD treatment. In this sample, after adjusting for depressed mood and body mass index (BMI), sleep heart rate was 3.8 BPM higher in those endorsing current ideation and a history of attempts than in those denying both. The investigators also describe in detail below a supportive case observed in Dr. Woodward's laboratory which, to our knowledge, represents the first extended acquisition of sleep behavior prior to a serious suicide attempt.
The proposal leverages the PI's expertise in zero-burden, mattress-actigraphic sleep recording originally motivated by the observation that PTSD patients rarely manifest sleep disturbances in the laboratory. The aforementioned data were obtained employing a high-accuracy, non-commercial, mattress actigraphic system developed by the PI (13-15), which was found acceptable to > 95% of the 900+ veteran PTSD inpatients with whom it has been used at the Trauma Recovery Program (TRP) at the VA Palo Alto Health Care System (~40,000 nights of recording). The proposed study will employ a low-cost, commercially-available alternative, the Sleepace RestOn, that can be mailed and user-installed. This system is also zero-burden as there is nothing to put on, take off, charge, or upload. In our pilot work, it has proven acceptable to veteran outpatients at high risk for suicide. Moreover, though its connection to a tablet computer, this system provides daily, web-based access to the raw actigraphic data enabling the direct verification of data quality and the application of custom algorithms to extract movement, heart rate, and respiratory amplitude.
Aim 1 will attempt to replicate and extend the aforementioned observations made in PTSD inpatients with and without suicidal ideation and histories of attempts in PTSD outpatients studied in the home. Aim 2 will attempt to replicate and extend Co-I Bernert's study demonstrating, in high-risk young adults, that weekly changes in sleep schedule variability predict weekly changes in suicidal ideation (1). Bernert's study period will be extended from three weeks to two months, and sleep heart rate will be included as a predictor. Suicide symptoms will be assessed weekly by telephone using the Depression Symptom Index - Suicide Severity (DSI-SS; 16), a brief, psychometrically-sound measure of suicide ideation intensity yielding a score from 0 to 12 (17). Mixed effects modeling (18) will be employed, and with respect to Aim 2, the temporal precedence of changes in sleep to changes in suicidal ideation intensity will be tested in order confirm that sleep changes meet criteria for true risk-factors (19). An established partnership with VA Suicide Prevention Coordinators (SPCs) will facilitate recruitment from the actuarial REACH VET list (20) and local hospital high-risk list while maximizing participant safety. An exploratory aim will estimate the contribution of certain participant factors likely to impact sleep scheduling or its measurement, in-bed media consumption, hypnotic medication, CPAP use, and alcohol/substance use. In the case of a positive study outcome, a multi-site R01 will be proposed including centralized data collection and review at the VA Center of Excellence for Suicide Prevention in Canandaigua, NY, under the direction of Co-I Pigeon, implementation science and health economic aims developed in collaboration with Co-I Marshall, and exploratory integration into the REACH VET algorithm.
- Conditions
- Suicidal Ideation, Sleep Disturbance
- Being tested
- in-home sleep recording
- Medical subject headings
- Suicidal Ideation, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-home sleep recordingDevice
in-home, nightly, zero-burden objective quantification of sleep scheduling and sleep heart rate via a mattress-top sensor (Sleepace RestOn) + ad lib quantification of blood SaO2 via a ring-based sensor (Bodimetrics Circul) + ad lib quantification of sleep and waking activity and heart rate via a wrist-worn sensor (Garmin Vivosmart 4)
| Study group | Role | What they receive |
|---|---|---|
| PTSD+Suicidal Ideation | US Military Veterans diagnosed with PTSD and identified via the REACH VET or local high-risk list as requiring intensified surveillance by their VA's Suicide Prevention Coordinators in collaboration with their Primary Care Providers Receives: Device: in-home sleep recording | |
| PTSD-Suicidal Ideation | US Military Veterans diagnosed with PTSD not identified as requiring intensified surveillance by their VA's Suicide Prevention Coordinators in collaboration with their Primary Care Providers Receives: Device: in-home sleep recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group differences in sleep scheduling variability
Between-group differences in sleep scheduling variability
Measured: 30 days
Between-group differences in sleep heart rate
Between-group differences in sleep heart rate
Measured: 30 days
Within-group (PTSD+Suicidal Ideation) covariance between objective sleep measures and suicidal ideation
Within-group (PTSD+Suicidal Ideation) covariance between objective sleep measures and suicidal ideation
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Oct 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744740
- Sponsor's protocol ID
- WOS0023AGG
- Status last verified
- Oct 2020
- First submitted
- 14 Oct 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per NIH-compliant data sharing initiative, all deidentified sleep and psychometric data would be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Home Sleep Monitoring to Detect Suicide Risk in Veterans
- ClinicalTrials.gov ID
- NCT04744740
- Acronym / sponsor ID
- WOS0023AGG
- Conditions
- Suicidal Ideation, Sleep Disturbance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 9 Feb 2021 (actual)
- 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 research will assess the ability of nightly objective sleep scheduling and sleep heart rate data to predict variation in suicidal ideation in U.S. military veterans identified as high-risk according to actuarial and/or clinical indicators. These data will be recorded using one of two low-cost, commercial, zero-burden, mattress actigraphic systems that enable remote, centralized, data access. Participants will be veterans accrued both from the REACH VET and local high-risk lists, a process involving collaboration with the Suicide Prevention Coordinator at the VA Palo Alto HCS. In order to minimize burden, participants will be screened by telephone, consented by mail and telephone, administered a brief admission psychometric interview by telephone, and mailed a sleep sensor system and instructions for its installation in their home. Once sleep data collection has commenced, a trained interviewer will contact the participant by telephone weekly and administer the Columbia-Suicide Severity Rating Scale. Data collection will continue for three months. The study targets a sample of 40 veterans. Longitudinal mixed effects modeling will be employed to determine whether changes in sleep scheduling and sleep heart rate predict changes in suicidal ideation.
Detailed description
Suicide is a devastating event that occurs at a very low base rate, rendering detection of acute suicide risk one of the signal challenges in behavioral science. Advancement in the detection of imminent risk requires new modalities of intensive, longitudinal data collection that are both acceptable and scalable. Recent developments in commercial, actigraphic sleep recording systems have opened a new avenue of approach to this challenge, enabling the automated collection and daily review of sleep scheduling and sleep heart rate (HR), both of which have demonstrated associations with suicidality in prior studies. Our team, comprising Drs. Steven Woodward (Director of the Sleep and Psychophysiology Laboratory of the National Center for PTSD), Rebecca Bernert (Director of the Suicide Prevention Center, Stanford University School of Medicine), Christina Khan (Director of the Thrive Clinic, Stanford University School of Medicine), and Wilfred Pigeon (Director of the Center of Excellence in Suicide Prevention, Department of Veterans Affairs) will pursue the following Aims.
AIM 1: To assess, in U.S. military veterans diagnosed with posttraumatic stress disorder (PTSD), whether sleep schedule variability and sleep heart rate, recorded in the home for one month using a low-cost, zero-burden, actigraphic sleep measurement system, can distinguish those who are at elevated actuarial risk for suicide from those who are not.
AIM 2: To assess, in U.S. military veterans diagnosed with PTSD, whether elevated sleep schedule variability and elevated sleep heart rates can predict increased suicidal ideation over a clinically-relevant surveillance period of two months.
The proposal is founded on observational and epidemiological studies supporting associations between sleep disturbance, basal heart rate and suicidality, including important contributions from Co-Is Bernert and Pigeon (1-12). Also supportive of the proposal are new observations from a sample of 71 U.S. Military veterans with deployment-related PTSD studied by the PI during inpatient PTSD treatment. In this sample, after adjusting for depressed mood and body mass index (BMI), sleep heart rate was 3.8 BPM higher in those endorsing current ideation and a history of attempts than in those denying both. The investigators also describe in detail below a supportive case observed in Dr. Woodward's laboratory which, to our knowledge, represents the first extended acquisition of sleep behavior prior to a serious suicide attempt.
The proposal leverages the PI's expertise in zero-burden, mattress-actigraphic sleep recording originally motivated by the observation that PTSD patients rarely manifest sleep disturbances in the laboratory. The aforementioned data were obtained employing a high-accuracy, non-commercial, mattress actigraphic system developed by the PI (13-15), which was found acceptable to > 95% of the 900+ veteran PTSD inpatients with whom it has been used at the Trauma Recovery Program (TRP) at the VA Palo Alto Health Care System (~40,000 nights of recording). The proposed study will employ a low-cost, commercially-available alternative, the Sleepace RestOn, that can be mailed and user-installed. This system is also zero-burden as there is nothing to put on, take off, charge, or upload. In our pilot work, it has proven acceptable to veteran outpatients at high risk for suicide. Moreover, though its connection to a tablet computer, this system provides daily, web-based access to the raw actigraphic data enabling the direct verification of data quality and the application of custom algorithms to extract movement, heart rate, and respiratory amplitude.
Aim 1 will attempt to replicate and extend the aforementioned observations made in PTSD inpatients with and without suicidal ideation and histories of attempts in PTSD outpatients studied in the home. Aim 2 will attempt to replicate and extend Co-I Bernert's study demonstrating, in high-risk young adults, that weekly changes in sleep schedule variability predict weekly changes in suicidal ideation (1). Bernert's study period will be extended from three weeks to two months, and sleep heart rate will be included as a predictor. Suicide symptoms will be assessed weekly by telephone using the Depression Symptom Index - Suicide Severity (DSI-SS; 16), a brief, psychometrically-sound measure of suicide ideation intensity yielding a score from 0 to 12 (17). Mixed effects modeling (18) will be employed, and with respect to Aim 2, the temporal precedence of changes in sleep to changes in suicidal ideation intensity will be tested in order confirm that sleep changes meet criteria for true risk-factors (19). An established partnership with VA Suicide Prevention Coordinators (SPCs) will facilitate recruitment from the actuarial REACH VET list (20) and local hospital high-risk list while maximizing participant safety. An exploratory aim will estimate the contribution of certain participant factors likely to impact sleep scheduling or its measurement, in-bed media consumption, hypnotic medication, CPAP use, and alcohol/substance use. In the case of a positive study outcome, a multi-site R01 will be proposed including centralized data collection and review at the VA Center of Excellence for Suicide Prevention in Canandaigua, NY, under the direction of Co-I Pigeon, implementation science and health economic aims developed in collaboration with Co-I Marshall, and exploratory integration into the REACH VET algorithm.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSD+Suicidal Ideation | – | Device: in-home sleep recordingUS Military Veterans diagnosed with PTSD and identified via the REACH VET or local high-risk list as requiring intensified surveillance by their VA's Suicide Prevention Coordinators in collaboration with their Primary Care Providers |
| PTSD-Suicidal Ideation | – | Device: in-home sleep recordingUS Military Veterans diagnosed with PTSD not identified as requiring intensified surveillance by their VA's Suicide Prevention Coordinators in collaboration with their Primary Care Providers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans with PTSD with or without elevated actuarial risk for suicide
Key inclusion criteria (3 listed)
- PTSD or partial PTSD
- Status on clinical high-risk list and subject to enhanced surveillance by the suicide prevention activity and staff at VAPAHCS (or not)
- Adequate cell phone service and/or wireless wife connectivity in sleeping quarters.
Key exclusion criteria (2 listed)
- Schizophrenia or psychotic disorder, autism-spectrum diagnoses medically unstable
- unable to speak and read English or otherwise incapable of providing informed consent
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 |
|---|---|---|
| in-home sleep recordingin-home, nightly, zero-burden objective quantification of sleep scheduling and sleep heart rate via a mattress-top sensor (Sleepace RestOn) + ad lib quantification of blood SaO2 via a ring-based sensor (Bodimetrics Circul) + ad lib quantification of sleep and waking activity and heart rate via a wrist-worn sensor (Garmin Vivosmart 4) | Device | PTSD+Suicidal Ideation, PTSD-Suicidal Ideation |
Primary outcome
Between-group differences in sleep scheduling variability
Time frame: 30 days
Between-group differences in sleep scheduling variability
Between-group differences in sleep heart rate
Time frame: 30 days
Between-group differences in sleep heart rate
Within-group (PTSD+Suicidal Ideation) covariance between objective sleep measures and suicidal ideation
Time frame: 60 days
Within-group (PTSD+Suicidal Ideation) covariance between objective sleep measures and suicidal ideation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: Yes. Per NIH-compliant data sharing initiative, all deidentified sleep and psychometric data would be shared
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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.
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 Suicidal Ideation and Sleep Disturbance, run by Palo Alto Veterans Institute for Research 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven H Woodwawrd, PhD (6502450450, steve.woodward@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group differences in sleep scheduling variability (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2021.