Clinical trial: Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken) (NCT03795987)

Eligibility criteria:
Inclusion Criteria:

          -  Veteran Enrolled in the Minneapolis/St. Cloud VAHCS.

          -  Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the
             fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

          -  Equal to or older than 22 years of age.

          -  Proficient in both reading and writing in the English language.

          -  Pittsburgh Sleep Quality Index (PSQI) score 10 or higher.

          -  Epworth Sleepiness Scale (ESS): On question #8 any score above "0" will prompt an
             additional question: Do you drive ("get behind the wheel") when you are drowsy? The
             answer must be "No" to be enrolled in the study due to safety concerns.

          -  Have repetitive nightmares contributing to disrupted sleep as reported by the patient

          -  Wireless Internet and two power outlets where they sleep

          -  Prazosin use; if yes, the patient may be included if tapered by prescribing provider.
             Taper must be completed and subject must be off prazosin for 2 days prior to
             enrollment.

        Exclusion Criteria:

          -  Patient Health Questionnaire-9 (PHQ-9) score greater than or equal to 20. A score of 1
             or more on the suicide ideation item of the PHQ-9 will trigger a risk assessment.

          -  Uncontrolled atrial fibrillation

          -  Current use of varenicline

          -  Current use of beta-blockers (unless ophthalmic solutions)

          -  Current use of non-dihydropyridines

          -  Current use of Prazosin for the treatment of nightmares (can include patients 2 days
             following taper and discontinuation) This would be coordinated with the prescribing
             provider

          -  Circadian rhythm disruption on a regular basis (shift-work)

          -  Known diagnosis of Obstructive Sleep Apnea

          -  Diagnosis of an active disorder of arousal from non-rapid eye movement sleep

          -  Diagnosis of rapid eye movement sleep behavior disorder

          -  Diagnosis of narcolepsy

          -  Alcohol Use Disorders Inventory Test (AUDIT) (score of 8 or higher)

          -  Drug Abuse Screening Test-10 (DAST-10) (score greater than 2)

          -  Suspicion of nightmares being secondary to substance abuse or withdrawal

          -  Diagnosis or suspicion of dementia

          -  Previous or foreseeable legal proceedings involving nightmares or trauma

          -  Nocturia that causes awakening from sleep

          -  Known sleepwalking

          -  Acting out of dreams prior to PTSD trauma
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 Years old.


Patient description (medical language): A 25-year-old woman comes to the clinic with her roommate.  The roommate says that the patient has twice fallen asleep while they were talking.  The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap.  She also reveals that she sometimes hears a voice prior to falling asleep.  She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately.

Patient description (patient's own words): I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep.

Does the patient match the trial criteria? Contradiction