TNT/NW: Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)
Sponsor: NightWare
Trial Details
| Condition | Stress Disorders, Post-Traumatic, Combat Disorders, Ptsd, Nightmare, Nightmares, REM-Sleep Type, Nightmare Disorder With Associated Non-Sleep Disorder |
| Intervention | NightWare Therapeutic System; Sham NightWare |
| Phase | NA |
| Status | Completed |
| Participants | 270 |
| Est. Completion | 31 May 2025 |
| Last Updated | 14 Apr 2026 |
Primary Outcome
Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to Day 30
Eligibility Criteria
Inclusion Criteria
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
Trial Sites
Countries
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