Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)

Completed · Not applicable

Conditions studied: Stress Disorders, Post-Traumatic, Combat Disorders, Ptsd, Nightmare, Nightmares, REM-Sleep Type, Nightmare Disorder With Associated Non-Sleep Disorder

In brief

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.

Key facts

Study ID

NCT03795987

Run by

NightWare

People needed

15

Starts

2019-02-07

Expected to finish

2019-08-14

Last updated by the study team

2020-02-26

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Minneapolis VA Healthcare System — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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