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This study examined a brainwave-based approach called HIRREM in active-duty military personnel and recent veterans who had a diagnosis or symptoms of post-traumatic stress disorder (PTSD). It enrolled male and female participants who had a PTSD diagnosis or active symptoms indicated by a certain screening score. It was conducted as a study without an assigned phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: Active duty military personnel, or recent veterans (Operation Enduring Freedom, Operation Iraqi Freedom, or Operation New Dawn), men and women, with a diagnosis of PTSD, or active symptoms suggesting PTSD as identified by a screening PCL-M score of 50 or greater, with or without traumatic brain injury (TBI), are eligible to participate in the study. Exclusion Criteria: * Unable, unwilling, or incompetent to provide informed consent * Physically unable to come to the study visits, or to sit in a chair for several hours * Known seizure disorder * Severe hearing impairment (because the subject will be using ear buds during HIRREM) * Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications (SSRI, or SNRI's), sleep medications such as zolpidem or eszopiclone, stimulants such as Adderall, Provigil, or Ritalin, or thyroid hormone * Anticipated and ongoing use of recreational drugs, alcohol, or energy drinks * Lack of internet or smart phone access (will maintain remote access daily sleep diary through 1 month post-HIRREM visit)