Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)

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 withdrawal) of certain
medications or substances, or associated with disorders including PTSD.

NightWare (Minneapolis, MN) has developed a novel approach to the treatment of nightmares.
Through the use of a smartwatch-based application that senses physiologic parameters, the
participant is aroused from sleep (without awakening the participant) so that the nightmare
is interrupted prior to reaching a threshold of severity in which the participant would
awaken in distress. Seconds later the participant returns to sleep without having experienced
a nightmare. This approach avoids risk from pharmacological treatment, avoids exacerbation of
symptoms from image rehearsal therapy and allows for a simple method with easily achieved
adherence compared to existing treatments.

The NightWare digital therapeutic system consists of a proprietary software application
installed on a smartwatch. The application has been effective in focus groups when used on
both Apple smartwatches and Motorola smartwatches. For the purposes of this study, the
investigators will be using only the Apple (Cupertino, CA) 3rd generation smartwatch and the
Apple iPhone. The NightWare application uses physiological markers obtained via the
smartwatch to determine by proprietary algorithm whether a participant is in the early stages
of a nightmare, but has not yet awoken in distress. As directed by the algorithm, the
smartwatch then applies varying degrees of vibratory stimulation to the wrist over variable
lengths of time with the intention of arousing the participant from sleep without eliciting
an awakening.

Inclusion Criteria:

- 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.

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