NightWare Open Enrollment Study (NWOES)
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|ClinicalTrials.gov Identifier: NCT03828656|
Recruitment Status : Enrolling by invitation
First Posted : February 4, 2019
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|PostTraumatic Stress Disorder Sleep Disorder Stress Disorder Sleep Initiation and Maintenance Disorders Combat Disorders Nightmares Associated With Chronic Post-Traumatic Stress Disorder Nightmare Nightmares, REM-Sleep Type||Device: NightWare Therapeutic System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NightWare Open Enrollment Study|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||February 1, 2021|
Experimental: Open Label Treatment Arm
Open-label Intervention with the NightWare Therapeutic System every night.
Device: NightWare Therapeutic System
A wearable digital therapeutic system that will measure physiologic data when worn during sleep to deliver a mild vibration via the watch to elicit arousal thereby disrupting nightmares. This detection and stimulation sequence will be performed according to NightWare's proprietary algorithm.
- Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to each subsequent 28 day evaluation period [ Time Frame: 0-730 days ]The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. This outcome is the difference between the global score on the Pittsburgh Sleep Quality Index (PSQI) score at baseline (Day 0) and average global PSQI score across the post-treatment initiation assessments (Days 14, 28 and every 28 days after that).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828656
|United States, New York|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Daniel R Karlin, MD MA||RationalPsych|