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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Steven H Woodwawrd, PhD contact

6502450450

steve.woodward@va.gov

Diana Villasenor, BA contact

650-3915983

diana.villasenor@va.gov

United States1 site, 1 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

    Recruiting

Other trials in United States

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.

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 groups in NCT04744740
Study groupRoleWhat they receive
PTSD+Suicidal IdeationUS 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 IdeationUS 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.

  1. Between-group differences in sleep scheduling variability

    Between-group differences in sleep scheduling variability

    Measured: 30 days

  2. Between-group differences in sleep heart rate

    Between-group differences in sleep heart rate

    Measured: 30 days

  3. 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.

  1. First posted9 Feb 2021
  2. Study start1 Oct 2020
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion30 Jun 2022 (estimated)

Resources

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)
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

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.

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