CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
PTSD wavelength-1 bright light +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02370173
NCT02370173N/ACompleted

A Non-Pharmacological Method for Enhancing Sleep in PTSD

University of Arizona·interventional·Posted Feb 24, 2015·Updated Jun 23, 2023

In Brief

A clinical study evaluating PTSD wavelength-1 bright light and PTSD wavelength-2 bright light for PTSD and Sleep Problems. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPTSD, Sleep Problems
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 24, 2015
Enrollment StartSep 1, 2014
Primary CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 11.4 years ago

Interventions

PTSD wavelength-1 bright lightdevice

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

PTSD wavelength-2 bright lightdevice

6 weeks daily light exposure, 30 minutes per morning.