Recruiting

Observational Study

Sponsor:

Palo Alto Veterans Institute for Research

Code:

NCT04744740

Conditions

Suicidal Ideation

Sleep Disturbance

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

in-home sleep recording

Study Details

Brief 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. 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.

Conditions

Suicidal Ideation

Sleep Disturbance

Study ID

NCT04744740

Start date

Oct 1, 2020

Status verified date

Oct, 2020

Completion date

Jun 30, 2022

Anticipated

Primary completion date

Jun 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. PTSD or partial PTSD
2. Status on clinical high-risk list and subject to enhanced surveillance by the suicide prevention activity and staff at VAPAHCS (or not)
3. Adequate cell phone service and/or wireless wife connectivity in sleeping quarters.

Exclusion Criteria:

1. Schizophrenia or psychotic disorder, autism-spectrum diagnoses medically unstable
2. unable to speak and read English or otherwise incapable of providing informed consent

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

Interventions

in-home sleep recording

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)

Primary outcome measure

  • Between-group differences in sleep scheduling variability [ Time Frame: 30 days ]
  • Between-group differences in sleep heart rate [ Time Frame: 30 days ]
  • Within-group (PTSD+Suicidal Ideation) covariance between objective sleep measures and suicidal ideation [ Time Frame: 60 days ]

Central Contacts and Locations

Central contacts

Locations

VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304

Contacts

More Information

Sponsor

Palo Alto Veterans Institute for Research

Last update posted

Feb 9, 2021

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Palo Alto Veterans Institute for Research on 2021-02-09.