Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken) (TNT/NW)
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|ClinicalTrials.gov Identifier: NCT04040387|
Recruitment Status : Enrolling by invitation
First Posted : July 31, 2019
Last Update Posted : March 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic Combat Disorders Ptsd Nightmare Nightmares, REM-Sleep Type Nightmare Disorder With Associated Non-Sleep Disorder||Device: NightWare Therapeutic System Device: Sham NightWare||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 :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||TNT/NW: Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)|
|Actual Study Start Date :||July 24, 2019|
|Estimated Primary Completion Date :||July 24, 2021|
|Estimated Study Completion Date :||August 24, 2022|
Experimental: Treatment Arm
Intervention with NightWare Therapeutic System
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.
Sham Comparator: Sham Arm
NightWare system set to not provide any interventions
Device: Sham NightWare
NightWare device not providing interventions
- Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to Day 60 [ Time Frame: 0-60 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 four post-treatment initiation assessments (Days 14, 30, 44 and 60).
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): NCT04040387
|United States, Florida|
|James A. Haley Veterans Administration Hospital|
|Tampa, Florida, United States, 33612|
|United States, Minnesota|
|Minneapolis VA Healthcare System|
|Minneapolis, Minnesota, United States, 55417|
|Study Chair:||Daniel R Karlin, MD MA||NightWare|