NIGHTWARE RCT STUDY

About this trial

This study will establish the safety and efficacy of the NightWare digital therapeutic system for the treatment of nightmare disorder associated with post-traumatic stress disorder (PTSD)-related sleep disturbance. The investigators hypothesize that the NightWare Digital Therapeutic System will significantly improve sleep quality in participants.

What is nightmare disorder?

Nightmare Disorder (nightmares) is a sleep disorder described by someone having frequent nightmares. Nightmares affect 2–8% of the general population with the occurrence of comorbid nightmares in those with PTSD being significantly higher at 72%. Nightmares result in impaired quality of life, insomnia, daytime sleepiness, fatigue, and suicidal thoughts.2–4 It may also worsen underlying psychological distress in people with depression and anxiety, resulting in poor occupational and or social functioning.2–4

What is nightware

NightWare improves sleep by interrupting nightmares when they happen. It provides a treatment option for patients with sleep disturbances related to Nightmare Disorder or nightmares associated with PTSD.

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RCT Study Design
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ELIGIBILITY AND ENROLLMENT CRITERIA
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Timeline for followup
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References

1. El-Solh, A. A. (2018). Management of nightmares in patients with posttraumatic stress disorder: Current perspectives. Nature and Science of Sleep, 10, 409–420. doi:10.2147/nss.s166089.
2. Sjöström N, Hetta J, Waern M. Persistent nightmares are associated with repeat suicide attempt: a prospective study. Psychiatry Res. 2009;170(2-3):208–211.
3. Kilpatrick D, Resnick H, Freedy J, et al. Posttraumatic stress disorder field trial: Evaluation of PTSD Construct Criteria A through E. In: Widiger T, Frances A, Pincus H, et al., Eds. DSM-IV Sourcebook. Vol 4. Washington, D.C.: American Psychiatric Press; 1994.
4. Li SX, Zhang B, Li AM, Wing YK. Prevalence and correlates of frequent nightmares: a community based 2-phase study. Sleep 2010;33(6):774–780.

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