Improving Sleep in Veterans With the Polytrauma Clinical Triad

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Decisional impairment and/or dementia

Current usage of a lightbox or negative ion generator

Shift work

History of macular degeneration and/or bipolar disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Morning Bright Light TherapyExperimental treatment 1 intervention
Group B: Negative Ion GeneratorSham comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

Self-reported sleep quality via the Pittsburgh Sleep Quality Index

The Pittsburgh Sleep Quality Index is a validated questionnaire assessing metrics related to sleep quality.

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

Other outcomes

Sponsors and contacts

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