A Non-Pharmacological Method for Enhancing Sleep in PTSD

Sponsor

University of Arizona (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02370173

Collaborator

U.S. Army Medical Research Acquisition Activity (U.S. Fed)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sleep disturbance is nearly ubiquitous among individuals suffering from PTSD and is a major problem among service members returning from combat deployments. The proposed study aims to test a novel, inexpensive, and easy to use approach to improving sleep among service members with PTSD.

Primary outcome measures will include not only PTSD symptom improvement but also include neuroimaging of brain structure, function, connectivity, and neurochemistry changes. The proposal is firmly grounded in the emerging scientific literature regarding sleep, light exposure, brain function, anxiety, and resilience. Prior evidence suggests that bright light therapy is effective for improving mood and fatigue, and our pilot data further suggest that this treatment may be effective for improving daytime sleepiness and brain functioning in brain injured individuals. Thus, this intervention, in our own research and in the work of others, has been shown to affect critical sleep regulatory systems. Improving sleep may be a vital component of recovery in these service members. Our approach would directly address this issue. Our preliminary data have shown that this approach is extremely well tolerated and is effective for improving sleep, mood, cognitive performance, and brain function among individuals with brain injuries.

Finally, the potential impact of this study is high because of the capability of transitioning the research to direct clinical application almost immediately. If the bright light treatment is demonstrated as effective, this approach would be readily available for nearly immediate large-scale implementation, as the devices have been widely used for years in other contexts, are already safety tested, and commercially available from several manufacturers for a very low cost. Thus, the impact of this research on treating PTSD would be high and immediate.

Condition or Disease	Intervention/Treatment	Phase
PTSD Sleep Problems	Device: PTSD wavelength-1 bright light Device: PTSD wavelength-2 bright light	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Non-Pharmacological Method for Enhancing Sleep in PTSD

Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

May 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PTSD wavelength-1 bright light 30 minutes of daily light exposure for 6 weeks	Device: PTSD wavelength-1 bright light 6 weeks of daily light exposure, 30 minutes per morning.
Placebo Comparator: PTSD wavelength-2 bright light 30 minutes of daily light exposure for 6 weeks	Device: PTSD wavelength-2 bright light 6 weeks daily light exposure, 30 minutes per morning.

Arm

Intervention/Treatment

Experimental: PTSD wavelength-1 bright light

30 minutes of daily light exposure for 6 weeks

Device: PTSD wavelength-1 bright light

6 weeks of daily light exposure, 30 minutes per morning.

Placebo Comparator: PTSD wavelength-2 bright light

30 minutes of daily light exposure for 6 weeks

Device: PTSD wavelength-2 bright light

6 weeks daily light exposure, 30 minutes per morning.

Outcome Measures

Primary Outcome Measures

Sleep Quality [Change from baseline at 6 weeks (post-treatment)]
The Subjective Measure: Pittsburgh Sleep Quality Index and Objective measure: Actigraphy, will be used to assess average sleep quality.
Neural activation during functional magnetic resonance imaging (fMRI) executive function task [Change from baseline performance at 6 weeks (post-treatment)]
Performance on neuropsychological assessment [Change from baseline performance at 6 weeks (post-treatment)]
The Automated Neuropsychiatric Assessment Metrics and the Repeatable Battery for the Assessment of Neuropsychological Status will be utilized to measure overall neurocognitive performance.
PTSD Symptoms [Change from baseline performance at 6 weeks (post-treatment)]
The PTSD Checklist will be used to measure PTSD symptoms.
Daytime Sleepiness [Change from baseline performance at 6 weeks (post-treatment)]
Subjective measures: Epworth Sleepiness Scale, and Stanford sleepiness Scale, and the Objective measure: Multiple Sleep Latency Test (MSLT) will be used to assess daytime sleepiness.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Having experienced a traumatic event within the past 10 years
Right handedness
18-50 years old
Primary language is English
No metal in body

Further eligibility will be determined through a phone screening. Please call (520) 626-8591 or go to uascanlab.com to check your eligibility for this study.