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In-Home Sleep Monitoring to Detect Suicide Risk in Veterans

NCT04744740 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-02-09

No results posted yet for this study

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

Interventions

DEVICE

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)

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04744740 on ClinicalTrials.gov