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Search / Trial NCT04040387

Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)

Launched by NIGHTWARE · Jul 29, 2019

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Ptsd Nightmare Nightmare Disorder Post Traumatic Stress Disorder Veteran Digital Therapeutic Digital Medicine

ClinConnect Summary

Nightmares are a common problem affecting 2-8% of the general population and a higher proportion of clinical populations. The negative consequences of untreated nightmares are significant and include impaired quality of life, sleep deprivation (often resulting in an increased intensity of nightmares), insomnia, daytime sleepiness, and fatigue. Untreated nightmares can also exacerbate the symptoms of underlying psychological dysfunction in people with depression and anxiety, leading to poor occupational and or social functioning. Nightmares can be idiopathic or associated with the use (or wi...

Gender

ALL

Eligibility 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)
  • 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

About Nightware

NightWare is a pioneering clinical trial sponsor focused on developing innovative solutions for managing sleep disorders, particularly post-traumatic stress disorder (PTSD). The company harnesses advanced technology, including wearable devices and digital health applications, to improve sleep quality and overall mental health outcomes for patients. NightWare is committed to rigorous scientific research and collaboration with healthcare professionals to validate its therapeutic approaches, ultimately aiming to enhance the quality of life for individuals affected by sleep disturbances. Through its clinical trials, NightWare seeks to contribute valuable insights to the field of sleep medicine and expand treatment options for those in need.

Locations

Tampa, Florida, United States

Cleveland, Ohio, United States

Bethesda, Maryland, United States

Fort Belvoir, Virginia, United States

Minneapolis, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Daniel R Karlin, MD MA

Study Chair

NightWare

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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