PTSDNCT03513848
Morning Light Treatment at Home to Reduce PTSD Symptoms
A study testing Retimer in people with PTSD, run by Rush University Medical Center at 1 site in United States.
Trial summary
There is evidence that some of the circadian photoreceptors, the intrinsically photosensitive retinal ganglion cells (ipRGCs), project directly to the amygdala, an area of the brain implicated in PTSD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PTSD
- What is being tested?
- Retimer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 28 Jun 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Probable PTSD based on the PCL-5 score
- Fluent in English
- Willingness and ability to comply with the protocol
Who cannot join
- Current or recent (past 6 months) alcohol or substance abuse problems
- Past or present psychotic or bipolar disorders
- Significant suicidal ideation or suicidal behaviors in past 6 months
- Unable or unwilling to give written informed consent.
- Severe hearing and memory problems.
- Cognitive impairment or mental retardation that interferes with subject being able to understand study requirements, consent form, etc.
Show all 27Show fewer
- Special events (e.g. weddings, exams, surgery) planned during 5 weeks of study
- Unable to travel for study visits
- Pending legal cases/litigation
- Has a serious or unstable medical illness (including but not limited to cardiovascular disease, uncontrolled diabetes, advanced liver disease, kidney failure, seizures, cancer which is likely to result in hospitalization in next year).
- Reports significant chronic migraine. For migraines, subjects will only be excluded if they report that bright light can trigger migraines.
- Vision problems, retinal disease, or history of eye surgery.
- Taking photosensitizing medications
- Have previously had light treatment.
- Uncontrolled narcolepsy, sleep apnea or restless leg syndrome
- Likely to have undiagnosed, significant sleep apnea
- Likely to have undiagnosed, significant restless leg syndrome
- Prescribed hypnotics, over the counter sleep aids and antidepressants permitted providing all medications stable for 30 days before and during the study). All current medications must be non-photosensitizing.
- If in psychotherapy must have been for at least 30 days.
- People taking melatonin will be asked to abstain for a month before and during the study
- Has traveled outside the central time zone
- Have worked a night-shift the past month.
- Has winter depression
- Is pregnant, trying to get pregnant or breastfeeding.
- Household has a child <2 years old or a child that does not sleep through the night
- Is unavailable for a 5 week period
- Fail urine drug test at screening visit (after prescribed medication accounted for)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
There is evidence that some of the circadian photoreceptors, the intrinsically photosensitive retinal ganglion cells (ipRGCs), project directly to the amygdala, an area of the brain implicated in PTSD. Thus, a self-administered morning light treatment at home (shifts clock earlier and stimulates ipRGCs) may be a potentially efficacious adjunctive strategy for reducing PTSD symptoms. This study will test a 4 week daily 1 hour morning light treatment (active vs placebo) in individuals with PTSD. Outcome measures include measures of PTSD and depression.
- Conditions
- PTSD
- Being tested
- Retimer, Retimer placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetimerDevice
The Retimer light device in this study is a commercially-available wearable light device. It permits ambulation while receiving light from LEDs positioned below the eyes. The LEDs emit green light (~500nm, 230 µW/m2, 500 lux), close to the peak sensitivity of circadian photoreceptors.
Retimer placeboDevice
The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.
| Study group | Role | What they receive |
|---|---|---|
| Bright Light | Experimental | Not described Receives: Device: Retimer |
| Dim Light | Placebo comparator | Not described Receives: Device: Retimer placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Checklist for DSM-5 (PCL-5) Scores Over 4 Weeks of Treatment
The PTSD Checklist for DSM-5 (PCL-5) is the gold standard measure of PTSD symptom severity. Range: 0-80. Higher scores indicate worse outcomes. We will assess change in PCL-5 scores over 4 weeks of treatment [Week 2 through Week 6 of the study].
Measured: Week 2 and Week 6
Secondary outcomes (1)
Change in Patient Health Questionnaire - 9 (PHQ-9) Scores Over 4 Weeks of Treatment
The Patient Health Questionnaire - 9 (PHQ-9) is the gold standard measure of depression symptom severity. Range: 0-27. Higher scores indicate worse outcomes. We will assess change in PHQ-9 scores over 4 weeks of treatment [Week 2 through Week 6 of the study].
Measured: Week 2 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start1 Apr 2016
- Primary completion27 Jun 2018
- Study completion28 Jun 2018
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 Rush University Medical CenterThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alyson Zalta, Rush University Medical Center
- Investigators
- Alyson Zalta, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513848
- Sponsor's protocol ID
- 15122102
- Status last verified
- Oct 2019
- First submitted
- 6 Feb 2018
- Last updated
- 23 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morning Light Treatment at Home to Reduce PTSD Symptoms
- ClinicalTrials.gov ID
- NCT03513848
- Acronym / sponsor ID
- 15122102
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 27 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Posted 23 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is evidence that some of the circadian photoreceptors, the intrinsically photosensitive retinal ganglion cells (ipRGCs), project directly to the amygdala, an area of the brain implicated in PTSD. Thus, a self-administered morning light treatment at home (shifts clock earlier and stimulates ipRGCs) may be a potentially efficacious adjunctive strategy for reducing PTSD symptoms. This study will test a 4 week daily 1 hour morning light treatment (active vs placebo) in individuals with PTSD. Outcome measures include measures of PTSD and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright Light | Experimental | Device: Retimer |
| Dim Light | Placebo comparator | Device: Retimer placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Probable PTSD based on the PCL-5 score
- Fluent in English
- Willingness and ability to comply with the protocol
Key exclusion criteria (27 listed)
- Current or recent (past 6 months) alcohol or substance abuse problems
- Past or present psychotic or bipolar disorders
- Significant suicidal ideation or suicidal behaviors in past 6 months
- Unable or unwilling to give written informed consent.
- Severe hearing and memory problems.
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 |
|---|---|---|
| RetimerThe Retimer light device in this study is a commercially-available wearable light device. It permits ambulation while receiving light from LEDs positioned below the eyes. The LEDs emit green light (~500nm, 230 µW/m2, 500 lux), close to the peak sensitivity of circadian photoreceptors. | Device | Bright Light |
| Retimer placeboThe Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing. | Device | Dim Light |
Primary outcome
Change in PTSD Checklist for DSM-5 (PCL-5) Scores Over 4 Weeks of Treatment
Time frame: Week 2 and Week 6
The PTSD Checklist for DSM-5 (PCL-5) is the gold standard measure of PTSD symptom severity. Range: 0-80. Higher scores indicate worse outcomes. We will assess change in PCL-5 scores over 4 weeks of treatment [Week 2 through Week 6 of the study].
1 secondary outcome
Change in Patient Health Questionnaire - 9 (PHQ-9) Scores Over 4 Weeks of Treatment
Time frame: Week 2 and Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for PTSD
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
Alyson Zalta, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retimer in people with PTSD, run by Rush University Medical Center 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?
The sponsor lists 3 inclusion and 27 exclusion criteria. 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 Oct 2019. 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 Oct 2019). 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?
Change in PTSD Checklist for DSM-5 (PCL-5) Scores Over 4 Weeks of Treatment (time frame: Week 2 and Week 6). 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 Oct 2019.