We want to learn how nightmares from trauma or posttraumatic stress disorder (PTSD) affect heart and artery health in women. We also want to see if a treatment called NightWare, which is used on a smartwatch, can help women with these nightmares sleep better and improve their heart and artery health.
Going through trauma and having PTSD can raise the risk of heart disease, but many studies haven’t looked closely at how this affects women. We also don't fully understand what causes the link between trauma, PTSD, and heart and blood vessel problems. This study wants to find out how nightmares from trauma affect heart and artery health in women. We also want to see if we can improve sleep and heart and artery health in women by reducing these nightmares.
You will first come in for a visit to see if you can join the study. If you qualify and have nightmares from trauma or PTSD, you will be randomly placed to one of two groups. You won’t get to choose your group. One group will get an active NightWare system. This includes a smartwatch, a smartphone, and an app. It is made to stop nightmares without waking you up. The other group will get a NightWare system that looks the same but does not stop nightmares. You will use the NightWare system every night at home for 8 weeks. You will also come in for 4 follow-up visits. At these visits, we will check your blood pressure, complete scans to measure your body fat and bone strength, and use an ultrasound to check the health of your blood vessels. You will also be asked to give blood and urine samples and fill out surveys. At home, you will fill out surveys and wear devices to keep track of your sleep, what you eat, and your activity level. You will also be asked to collect your urine over 24 hours. If you qualify but do not have nightmares from trauma or PTSD, you will come in for 2 visits. These visits will include the same tests and samples. At home, you will fill out surveys and wear devices to keep track of your sleep, what you eat, and your activity level. You will also be asked to collect your urine over 24 hours.
If you qualify and have nightmares from trauma or PTSD, the study will last about 20 to 24 weeks. This includes 8 weeks of using the NightWare system at home. If you qualify but do not have nightmares from trauma or PTSD, the study will last about 8 to 12 weeks.
You may be able to join if you:
Protocol Number: 24-1948