Status:
UNKNOWN
Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)
Lead Sponsor:
NightWare
Collaborating Sponsors:
Minneapolis Veterans Affairs Medical Center
Louis Stokes VA Medical Center
Conditions:
Stress Disorders, Post-Traumatic
Combat Disorders
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
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 disorde...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 24 2024
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04040387
Start Date
July 24 2019
End Date
August 24 2024
Last Update
November 8 2023
Active Locations (4)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
2
Minneapolis VA Healthcare System
Minneapolis, Minnesota, United States, 55417
3
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, United States, 44106
4
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States, 22060