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NCT02370173 · ClinicalTrials.gov registry record · NA
A Non-Pharmacological Method for Enhancing Sleep in PTSD
A NA study of PTSD and Sleep Problems, sponsored by University of Arizona.
- Completed
- Registry status
- NA
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT02370173: Completed NA study of PTSD and Sleep Problems, sponsored by University of Arizona.
NCT02370173 is a NA study of PTSD and Sleep Problems that has completed, run by University of Arizona. The registered enrollment target is 90 participants, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02370173, a NA study of PTSD and Sleep Problems, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Actigraphy was used as a measurement of individual sleep efficiency calculating total sleep time (minutes asleep) divided by total rest time (time in bed- minutes in bed). This produces a percentage efficiency calculation that can range 0-100%, higher percentages indicates more time asleep while in bed.
Conditions Studied
Interventions
- DEVICE PTSD wavelength-1 bright light
- DEVICE PTSD wavelength-2 bright light
Study Locations (1)
Arizona
- University of Arizona Psychiatry Department - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2014-09 |
| Est. Completion | 2020-04 |
| Phase | NA |
What the finished NCT02370173 record still lists
NCT02370173 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (70% lower).
The record links to 2 conditions, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which PTSD wavelength-1 bright light is the first listed.
NCT02370173 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT02370173 about?
NCT02370173 is a clinical study titled "A Non-Pharmacological Method for Enhancing Sleep in PTSD". 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 out...
What is the current status of trial NCT02370173?
This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2014-09. Estimated completion is 2020-04.
What conditions does trial NCT02370173 study?
This clinical trial studies the following conditions: PTSD, Sleep Problems.
What interventions are being tested in trial NCT02370173?
The interventions under investigation include: PTSD wavelength-1 bright light (DEVICE), PTSD wavelength-2 bright light (DEVICE).
Who is sponsoring clinical trial NCT02370173?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02370173 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02370173's enrollment target sits among peer trials
90 70th of 154 higher than 85 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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