NightWare for Nightmares

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Colorado CCTSI CTRC, Denver, CO
Nightmares+8 More
NightWare - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular aging and autonomic function in adults with nightmares related to PTSD.

Eligible Conditions

  • Disorders of the Autonomic Nervous System
  • Nightmares
  • Post Traumatic Stress Disorder (PTSD)
  • Vascular Stiffness
  • Endothelial Dysfunction
  • Cardiovascular Diseases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: Measured before and after 6 weeks of NightWare and sham conditions

Week 6
Change in 1utonomic function - BRS
Change in C-Reactive Protein
Change in CESD
Change in CSSR-S
Change in Epworth sleepiness scale (ESS)
Change in Interleukin-6
Change in Nightmare disorder index
Change in Norepinephrine
Change in Oxidized LDL
Change in PCL-5
Change in PSQI
Change in PSQI-A
Change in SF-36
Change in Total antioxidant status
Change in autonomic function - HRV
Change in endothelial function
Change in large elastic artery stiffness
Change in large elastic artery stiffness -carotid artery

Trial Safety

Trial Design

2 Treatment Groups

NightWare
1 of 2
Sham NightWare
1 of 2
Experimental Treatment
Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: NightWare · Has Placebo Group · N/A

NightWare
Device
Experimental Group · 1 Intervention: NightWare · Intervention Types: Device
Sham NightWare
Device
ShamComparator Group · 1 Intervention: Sham NightWare · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured before and after 6 weeks of nightware and sham conditions
Closest Location: University of Colorado CCTSI CTRC · Denver, CO
Photo of Denver  1Photo of Denver  2Photo of Denver  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Nightmares
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a resting blood pressure of <160/100 mmHg.
You have a fasting glucose level of <126 mg/dL.
You are a non-smoker.
You have a PSQI score of 6 or higher.
Individuals who are not able to drive a car when they are drowsy are not eligible for this study.
You are either premenopausal or postmenopausal.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.