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Morning Light Treatment at Home to Reduce PTSD Symptoms

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Status

Completed

Conditions

PTSD

Treatments

Device: Retimer placebo
Device: Retimer

Study type

Interventional

Funder types

Other

Identifiers

NCT03513848
15122102

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Probable PTSD based on the PCL-5 score
  • Fluent in English
  • Willingness and ability to comply with the protocol

Exclusion criteria

  • 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.
  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

15 participants in 2 patient groups, including a placebo group

Bright Light
Experimental group
Treatment:
Device: Retimer
Dim Light
Placebo Comparator group
Treatment:
Device: Retimer placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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