Improving Sleep in Veterans With the Polytrauma Clinical Triad

NCT06477796 | Recruiting

• 2 other identifiers: D4822-RI01RX004822
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

polytrauma clinical triad; TBI; PTSD

Outcome Measures

Primary Outcomes (1)

• Sleep Efficiency via wrist based actigraphy

  Sleep efficiency is defined by the total time asleep divided by total time spent in bed

  Pre- and post-4 weeks of MBLT or sham treatment

Secondary Outcomes (1)

• Self-reported sleep quality via the Pittsburgh Sleep Quality Index

  Pre- and post-4 weeks of MBLT or sham treatment

Study Arms (2)

Morning Bright Light Therapy

EXPERIMENTAL

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

Device: Morning Bright Light Therapy

Negative Ion Generator

SHAM COMPARATOR

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

Device: Negative Ion Generator

Interventions

Morning Bright Light Therapy DEVICE

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

Also known as: Lightbox, light therapy

Morning Bright Light Therapy

Negative Ion Generator DEVICE

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

Negative Ion Generator

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran
• English speaking with phone and internet access
• Current self-reported sleep disturbances
• Clinical stable for current pharmacologic or behavioral health treatments for depression, anxiety, sleep and pain
• Documented history of TBI

You may not qualify if:

• Decisional impairment and/or dementia
• Current usage of a lightbox or negative ion generator
• Shift work
• History of macular degeneration and/or bipolar disorder
• Evidence for suicidal ideation
• Cancer diagnosis within the past 6 months
• Surgery within the past 6 months
• Substance abuse within the past 6-12 months
• Significant impairing post-stroke residual hemiparesis

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic; Chronic Pain

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jonathan E Elliott, PhD

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan E Elliott, PhD

CONTACT

(503) 220-8262; jonathan.elliott@va.gov

Joshua P Kreider

CONTACT

(503) 220-8262; Joshua.Kreider@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the intervention by way of study personnel's description. Subjects will be told that both devices may or may not be active and thus, will be unaware that all light boxes are active and all negative ion generators are inactivated.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to receive MBLT or a sham/no-light control. Subjects randomized to receive MBLT will be given a light box (LightPad, Aurora Light Solutions) to take home. Subjects randomized to receive the sham/no-light control will be given a modified negative ion generator.

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): September 29, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)