RECRUITING

Improving Sleep in Veterans With the Polytrauma Clinical Triad

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Sleep Intervention to Improve Quality of Life and Symptom Management in Veterans With the Polytrauma Clinical Triad

Quick Facts

Study Start:2025-05-01
Study Completion:2028-09-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06477796

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veteran
  2. * English speaking with phone and internet access
  3. * Current self-reported sleep disturbances
  4. * Clinical stable for current pharmacologic or behavioral health treatments for depression, anxiety, sleep and pain
  5. * Documented history of TBI
  1. * Decisional impairment and/or dementia
  2. * Current usage of a lightbox or negative ion generator
  3. * Shift work
  4. * History of macular degeneration and/or bipolar disorder
  5. * Evidence for suicidal ideation
  6. * Cancer diagnosis within the past 6 months
  7. * Surgery within the past 6 months
  8. * Substance abuse within the past 6-12 months
  9. * Significant impairing post-stroke residual hemiparesis

Contacts and Locations

Study Contact

Jonathan E Elliott, PhD
CONTACT
(503) 220-8262
jonathan.elliott@va.gov
Joshua P Kreider
CONTACT
(503) 220-8262
Joshua.Kreider@va.gov

Principal Investigator

Jonathan E Elliott, PhD
PRINCIPAL_INVESTIGATOR
VA Portland Health Care System, Portland, OR

Study Locations (Sites)

VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01
Study Completion Date2028-09-29

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2028-09-29

Terms related to this study

Keywords Provided by Researchers

  • polytrauma clinical triad
  • TBI
  • PTSD

Additional Relevant MeSH Terms

  • Traumatic Brain Injury
  • Post-traumatic Stress Disorder
  • Chronic Pain