A Non-Pharmacological Method for Enhancing Sleep in PTSD

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2020-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neurobiological Correlates of Post Traumatic Stress Disorder (PTSD) During Rapid Eye Movement (REM) Sleep

NCT00871650

Post-Traumatic Stress Disorder

COMPLETED

Bright Light: An Adjunct Treatment for Combat Posttraumatic Stress Disorder (PTSD)

NCT00701064

Posttraumatic Stress Disorder

COMPLETED NA

Accelerated Image-Guided Robotically Delivered Transcranial Magnetic Stimulation for Combat PTSD

NCT06587659

Stress Disorders, Post-Traumatic

COMPLETED NA

Effects of CPAP Therapy on PTSD Symptoms

NCT02019914

PTSD Sleep Obstructive Sleep Apnea +1 more

COMPLETED

Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans

NCT01637584

Non PTSD PTSD

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

PTSD Sleep Problems

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PTSD wavelength-1 bright light

30 minutes of daily light exposure for 6 weeks

Group Type EXPERIMENTAL

PTSD wavelength-1 bright light

Intervention Type DEVICE

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

PTSD wavelength-2 bright light

30 minutes of daily light exposure for 6 weeks

Group Type PLACEBO_COMPARATOR

PTSD wavelength-2 bright light

Intervention Type DEVICE

6 weeks daily light exposure, 30 minutes per morning.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PTSD wavelength-1 bright light

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

Intervention Type DEVICE

PTSD wavelength-2 bright light

6 weeks daily light exposure, 30 minutes per morning.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No