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Improving Sleep in Veterans With TBI

A Sleep Intervention to Improve Rehabilitation in Veterans With Chronic mTBI

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03785600
Acronym
SPTBI
Enrollment
77
Registered
2018-12-24
Start date
2019-11-01
Completion date
2024-09-30
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury, sleep-wake disturbances, Veterans, chronic pain

Brief summary

Traumatic brain injury (TBI) is a major cause of disability in the Veteran population, often resulting in chronic pain and sleep disturbances, among other issues. Extensive rehabilitative efforts are usually required and often prevent return to the workforce and community. Disturbed sleep and excessive daytime sleepiness are among the most pervasive and enduring problems after TBI, which the investigators hypothesize is a significant contributor to these functional impairments and an impediment toward rehabilitation. Thus, this research aims to enhance sleep quality as a means to reduce pain and improve quality of life and functional outcome measures in Veterans with TBI. The investigators predict that the proposed intervention, morning bright light therapy, if found effective, will be cost-effective, rapidly deployable, and highly accepted by Veterans with TBI.

Detailed description

Each year \ 2.5 million people sustain a traumatic brain injury (TBI). Also a prominent general public health issue, TBI is particularly prevalent in Veterans, with 60-80% reporting a history of TBI. Over 80% of all TBI are categorized as mild TBI (mTBI), which is associated with a myriad of short- and long-term complications. Two of the principal complicating factors associated with mTBI are sleep-wake disturbances (e.g., insomnia, excessive daytime sleepiness, and circadian rhythm sleep disorders) and chronic pain, including headache and diffuse/global pain. Sleep-wake disturbances and chronic pain have an independent prevalence of \ 70%, individually impair quality of life, impede effective rehabilitative therapies, and have staggering functional and economic impacts. Furthermore, there is a strong bidirectional relationship between sleep-wake disturbances and pain such that impaired sleep exacerbates pain, which leads to greater impairments in sleep and worse pain. This vicious cycle between sleep disturbances and pain, which is a particularly prevalent and detrimental condition in Veterans with chronic mTBI, represents a central challenge precluding effective treatment and ultimately, improving Veteran quality of life. Although there are pharmacological and non-pharmacological therapies for chronic pain, the presence of TBI significantly complicates the effectiveness of these treatment options, and have significant adverse effects (e.g., long-term prescription opioid dependence, misuse, or overdose). The investigators believe there is profound potential to intervene at the sleep level, and, by improving sleep quality, enable Veterans with chronic mTBI to better manage their pain and end this vicious cycle. This proposal aims to apply a sleep intervention to improve chronic pain in Veterans with mTBI. The investigators propose to use morning bright light therapy (MBLT), a readily deployable, cost-effective, non-pharmacologic, and home-based sleep intervention, to improve sleep-wake disturbances and therefore ameliorate chronic pain and improve quality of life in Veterans with chronic mTBI. Outcomes will be assessed pre- and post-intervention, and at a 3-month follow-up time point. The central hypothesis is that MBLT will improve sleep quality and ameliorate pain, resulting in improved quality of life in Veterans with chronic mTBI.

Interventions

Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.

Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Veteran * Medical record-confirmed diagnosis of mTBI * Current self-reported sleep-wake disturbances * defined by clinically abnormal Insomnia Severity Index and/or Functional Outcomes of Sleep scores * Moderate to severe pain * defined as a score of 4 on an 11-point scale94) persisting for longer than 6 months * English speaking with phone access

Design outcomes

Primary

MeasureTime frameDescription
Change in Self-reported PainPre- and post-4 weeks of Morning Bright Light Therapy (MBLT) or sham treatment.NIH Patient Reported Outcomes Measurement Information System (PROMIS) pain interference short-form 4a. 4 questions; each question is a 1-5 Likert scale, total score range is 4-20. Higher scores represent greater pain interference. \*all are reported as total score, no subscale scores present.

Countries

United States

Participant flow

Participants by arm

ArmCount
Morning Bright Light Therapy
Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up. Morning Bright Light Therapy: Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
44
Negative Ion Generator
Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up. Negative Ion Generator: Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
20
Total64

Baseline characteristics

CharacteristicMorning Bright Light TherapyTotalNegative Ion Generator
Age, Continuous53.6 years
STANDARD_DEVIATION 13.4
53.1 years
STANDARD_DEVIATION 13.6
51.8 years
STANDARD_DEVIATION 14.3
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants7 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
37 Participants56 Participants19 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants4 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
2 Participants3 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
38 Participants54 Participants16 Participants
Sex: Female, Male
Female
10 Participants14 Participants4 Participants
Sex: Female, Male
Male
34 Participants50 Participants16 Participants
Years of Education16.5 years
STANDARD_DEVIATION 1.8
16.2 years
STANDARD_DEVIATION 1.9
15.6 years
STANDARD_DEVIATION 1.9

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 530 / 24
other
Total, other adverse events
0 / 531 / 24
serious
Total, serious adverse events
0 / 530 / 24

Outcome results

Primary

Change in Self-reported Pain

NIH Patient Reported Outcomes Measurement Information System (PROMIS) pain interference short-form 4a. 4 questions; each question is a 1-5 Likert scale, total score range is 4-20. Higher scores represent greater pain interference. \*all are reported as total score, no subscale scores present.

Time frame: Pre- and post-4 weeks of Morning Bright Light Therapy (MBLT) or sham treatment.

ArmMeasureGroupValue (MEAN)Dispersion
Morning Bright Light TherapyChange in Self-reported PainMean Pre-Intervention Pain Interference9.8 Score on Pain InterferenceStandard Deviation 4.8
Morning Bright Light TherapyChange in Self-reported PainMean Post-Intervention Pain Interference9.3 Score on Pain InterferenceStandard Deviation 4.8
Negative Ion GeneratorChange in Self-reported PainMean Pre-Intervention Pain Interference10.2 Score on Pain InterferenceStandard Deviation 4.7
Negative Ion GeneratorChange in Self-reported PainMean Post-Intervention Pain Interference10.0 Score on Pain InterferenceStandard Deviation 5
p-value: <0.02t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026