PTSDNCT02370173
A Non-Pharmacological Method for Enhancing Sleep in PTSD
A study testing PTSD wavelength-1 bright light and PTSD wavelength-2 bright light in people with PTSD and Sleep Problems, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- PTSD, Sleep Problems
- What is being tested?
- PTSD wavelength-1 bright light and PTSD wavelength-2 bright light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Psychiatry Department
Tucson, Arizona, 85724
About this study
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.
- Conditions
- PTSD, Sleep Problems
- Being tested
- PTSD wavelength-1 bright light, PTSD wavelength-2 bright light
- Keywords
- PTSD, Stress, Sleep Problems, Brain imaging, fMRI
- Medical subject headings
- Stress Disorders, Post-Traumatic, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| PTSD wavelength-1 bright light | Experimental | 30 minutes of daily light exposure for 6 weeks Receives: Device: PTSD wavelength-1 bright light |
| PTSD wavelength-2 bright light | Placebo comparator | 30 minutes of daily light exposure for 6 weeks Receives: Device: PTSD wavelength-2 bright light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
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.
Measured: Sleep Efficiency was calculated at Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline)
Subjective Sleep Quality
Pittsburgh Sleep Quality Index is a measurement of subjective self-report sleep quality that uses both free response and Likert scale responses. The range of scores possible are 0 to 21. Higher scores indicate worse subjective sleep quality.
Measured: Results 6 weeks post-treatment
Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing Task
Activation of medial prefrontal cortex and anterior cingulate cortex (also prefrontal) during functional magnetic resonance imaging (fMRI) Backward Masked Affect Task (BMAT) emotion processing task. Contrast weight/effect scores for prefrontal area [MNI coordinates: 18,42,12] measured contrasts in activation between neutral images and activation when emotional images (fear images) were presented during the task. Higher scores indicate a greater difference or contrast between the neutral signal and emotional signal during the fMRI task.
Measured: Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline)
Performance on Neuropsychological Assessment
The Repeatable Battery for the Assessment of Neuropsychological Status will be utilized to measure overall neurocognitive performance. It covers five domains of cognition: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory resulting in a total neurocognitive performance score. The range of overall total neurocognitive performance scores is 40-160 points. Higher scores on this scale represent a higher capacity for executive function.
Measured: Performance results at 6 weeks post-treatment.
PTSD Symptoms
Post Traumatic Stress Disorder Checklist 5 (PCL-5).The PTSD Checklist for DSM-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items are summed to provide a total severity score (range = 0-80). Higher scores indicate greater presence or severity of PTSD symptoms.
Measured: Performance results at 6 weeks post-treatment.
Daytime Sleepiness (ESS)
Epworth Sleepiness Scale is a subjective measure of daytime sleepiness. This is on a 4-point Likert scale, each item has a range of 0 to 3 points. The total score range for this is 0-24 points. Higher scores indicate more severe daytime sleepiness.
Measured: Performance results at 6 weeks post-treatment
Daytime Sleepiness (SSS)
Stanford Sleepiness Scale is a one item scale assessing current level of alertness. The range of points possible is 1-7, with higher scores indicating that sleep onset is soon. This scale was given at three different time points during baseline assessment and post treatment.
Measured: Performance results at 6 weeks post-treatment.
Daytime Sleepiness (MSLT)
Multiple Sleep Latency Test (MSLT). Participants were administered a modified Multiple Sleep Latency Test. In the multiple sleep latency test (MSLT), the participant was given 3 opportunities to nap for 20 minutes every two hours. Sleep latency scores are calculated in the number of seconds to fall asleep during their mandated sleep session. Range is from 0 seconds to 1200 seconds.
Measured: Change from baseline performance at 6 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Responsible party
- Principal investigator, William D. Killgore, University of Arizona
- Investigators
- William Killgore, Ph.D., Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370173
- Sponsor's protocol ID
- 1407389306A003
- Status last verified
- May 2023
- First submitted
- 15 Oct 2014
- Last updated
- 23 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Pharmacological Method for Enhancing Sleep in PTSD
- ClinicalTrials.gov ID
- NCT02370173
- Acronym / sponsor ID
- 1407389306A003
- Conditions
- PTSD, Sleep Problems
- Keywords
- PTSD, Stress, Sleep Problems, Brain imaging, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Study start
- Sep 2014
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Posted 23 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSD wavelength-1 bright light | Experimental | Device: PTSD wavelength-1 bright light30 minutes of daily light exposure for 6 weeks |
| PTSD wavelength-2 bright light | Placebo comparator | Device: PTSD wavelength-2 bright light30 minutes of daily light exposure for 6 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTSD wavelength-1 bright light6 weeks of daily light exposure, 30 minutes per morning. | Device | PTSD wavelength-1 bright light |
| PTSD wavelength-2 bright light6 weeks daily light exposure, 30 minutes per morning. | Device | PTSD wavelength-2 bright light |
Primary outcome
Sleep Efficiency
Time frame: Sleep Efficiency was calculated at Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline)
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.
Subjective Sleep Quality
Time frame: Results 6 weeks post-treatment
Pittsburgh Sleep Quality Index is a measurement of subjective self-report sleep quality that uses both free response and Likert scale responses. The range of scores possible are 0 to 21. Higher scores indicate worse subjective sleep quality.
Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Emotion Processing Task
Time frame: Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline)
Activation of medial prefrontal cortex and anterior cingulate cortex (also prefrontal) during functional magnetic resonance imaging (fMRI) Backward Masked Affect Task (BMAT) emotion processing task. Contrast weight/effect scores for prefrontal area [MNI coordinates: 18,42,12] measured contrasts in activation between neutral images and activation when emotional images (fear images) were presented during the task. Higher scores indicate a greater difference or contrast between the neutral signal and emotional signal during the fMRI task.
Performance on Neuropsychological Assessment
Time frame: Performance results at 6 weeks post-treatment.
The Repeatable Battery for the Assessment of Neuropsychological Status will be utilized to measure overall neurocognitive performance. It covers five domains of cognition: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory resulting in a total neurocognitive performance score. The range of overall total neurocognitive performance scores is 40-160 points. Higher scores on this scale represent a higher capacity for executive function.
PTSD Symptoms
Time frame: Performance results at 6 weeks post-treatment.
Post Traumatic Stress Disorder Checklist 5 (PCL-5).The PTSD Checklist for DSM-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items are summed to provide a total severity score (range = 0-80). Higher scores indicate greater presence or severity of PTSD symptoms.
Daytime Sleepiness (ESS)
Time frame: Performance results at 6 weeks post-treatment
Epworth Sleepiness Scale is a subjective measure of daytime sleepiness. This is on a 4-point Likert scale, each item has a range of 0 to 3 points. The total score range for this is 0-24 points. Higher scores indicate more severe daytime sleepiness.
Daytime Sleepiness (SSS)
Time frame: Performance results at 6 weeks post-treatment.
Stanford Sleepiness Scale is a one item scale assessing current level of alertness. The range of points possible is 1-7, with higher scores indicating that sleep onset is soon. This scale was given at three different time points during baseline assessment and post treatment.
Daytime Sleepiness (MSLT)
Time frame: Change from baseline performance at 6 weeks (post-treatment)
Multiple Sleep Latency Test (MSLT). Participants were administered a modified Multiple Sleep Latency Test. In the multiple sleep latency test (MSLT), the participant was given 3 opportunities to nap for 20 minutes every two hours. Sleep latency scores are calculated in the number of seconds to fall asleep during their mandated sleep session. Range is from 0 seconds to 1200 seconds.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Killgore, Ph.D. principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTSD wavelength-1 bright light and PTSD wavelength-2 bright light in people with PTSD and Sleep Problems, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (time frame: Sleep Efficiency was calculated at Baseline (Pre-Treatment) and Post-Treatment (6 Weeks after Baseline)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.