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Sponsor: NightWare
Conditions: Stress Disorders, Post-Traumatic, Combat Disorders, Ptsd, Nightmare, Nightmares, REM-Sleep Type
Interventions: NightWare Therapeutic System, Sham NightWare
Countries: United States
This study will provide preliminary estimates of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application) for the treatment of nightmare disorder associated with post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with the NightWare digital therapeutic system. The investigators hypothesize that the NightWare digital therapeutic system will significantly improve sleep quality in participants with PTSD-Related nightmares and poor sleep quality.
Sex: ALL
Age: 22 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria:
* Veterans and Active-Duty Service Member Enrolled in the Minneapolis/St. Cloud VAHCS, Louis Stokes VAHCS in Cleveland, Walter Reed National Military Medical Center, or Fort Belvoir Community Hospital
* 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)
* Untreated 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- Bethesda, Maryland, United States
- Minneapolis, Minnesota, United States
- Cleveland, Ohio, United States
- Charleston, South Carolina, United States