NightWare Open Enrollment Study — NWOES  

PostTraumatic Stress Disorder Clinical Trial

Official title: NightWare Open Enrollment Study

Status Enrolling by invitation

Clinical Trial Summary

This study will provide measures 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.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Combat Disorders
• Disease
• Nightmare
• Nightmares Associated With Chronic Post-Traumatic Stress Disorder
• Nightmares, REM-Sleep Type
• PostTraumatic Stress Disorder
• Sleep Disorder
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders
• Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT03828656
• Study type: Interventional
• Source: NightWare
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2019
• Completion date: February 1, 2022