Improving Sleep in Veterans With the Polytrauma Clinical Triad

Part of paid clinical trials in Portland, Oregon.

Sponsor
VA Office of Research and Development
Study ID
NCT06477796
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Jun 2025
Primary completion
Dec 1, 2027
Completion
Sep 29, 2028

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Morning Bright Light Therapy
    Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 120 minutes of waking up.
  • Sham Comparator: 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.

Primary Outcome Measure

Sleep Efficiency via wrist based actigraphy [ Time Frame: Pre- and post-4 weeks of MBLT or sham treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Portland Health Care System, Portland, ORPortlandOregon97207-2964
Jonathan E Elliott, PhD
[email protected]
503-220-8262
Jonathan E Elliott, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Portland, OR

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
VA Portland Health Care System, Portland, OR· Portland, OR

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