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Improving Sleep in Veterans With the Polytrauma Clinical Triad

NCT06477796 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-06-27

No results posted yet for this study

Summary

The "polytrauma clinical triad" (PCT), a highly disabling constellation of factors, is defined by the coexistence of traumatic brain injury, post-traumatic stress disorder, and chronic pain. Veterans with the PCT are medically complex, often refractory to conventional therapies, and suffer from additional related chronic sequela. Notably, sleep disturbances and cognitive impairment, which the investigators hypothesize are significant contributing factors to these functional impairments and an impediment toward rehabilitation. Thus, the investigators' research aims to intervene "at the level of sleep", and by improving sleep, improve these interconnected, disabling, and difficult to treat enduring complexities associated with the PCT - ultimately to improve Veteran quality of life, functional independence, and restorative function. The investigators predict that the proposed intervention, morning bright light therapy, which is cost-effective, rapidly deployable and home-based, will be effective in improving sleep and overall PCT symptom management, thereby, resulting in a measurable and impactful improvement in quality of life.

Conditions

Interventions

DEVICE

Morning Bright Light Therapy

Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 120 minutes of waking up.

DEVICE

Negative Ion Generator

Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 120 minutes of waking up.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Jonathan E Elliott, PhD · VA Portland Health Care System, Portland, OR

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2027-12-01
Completion
2028-09-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06477796 on ClinicalTrials.gov