Purpose of this Study
We are doing this study to understand how your sleep can effect biomarkers of heart disease in people with posttraumatic stress disorder (PTSD) and insomnia.
Who Can Participate?
Eligibility
-Adults ages 40-59 who:
-Have or could possibly have PTSD
-Have insomnia
-Have or could possibly have PTSD
-Have insomnia
Age Range
40-59
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, and are eligible to participate, you will complete some activities for a week, which include:
-Wear a wristband monitor for one week (we will give this to you)
-Keep a sleep diary for 1 week while you wear the wristband
-Collect your urine for 24 hours
-Wear a blood pressure monitor for 24 hours
-Provide a blood sample
-An ultrasound on your arm (done in-person at the clinic)
After the first week, you will:
-Report on your sleep daily
-Be assigned to Group 1 or Group 2
---Group 1 will get 8 weeks of sessions of in-person treatment for insomnia.
---Group 2 will have the study coordinator contact you once a week to check in about your sleep symptoms
After that you will:
-Complete the same activities as you did at the beginning of the study
-Come in six months later to do the activities again
-Wear a wristband monitor for one week (we will give this to you)
-Keep a sleep diary for 1 week while you wear the wristband
-Collect your urine for 24 hours
-Wear a blood pressure monitor for 24 hours
-Provide a blood sample
-An ultrasound on your arm (done in-person at the clinic)
After the first week, you will:
-Report on your sleep daily
-Be assigned to Group 1 or Group 2
---Group 1 will get 8 weeks of sessions of in-person treatment for insomnia.
---Group 2 will have the study coordinator contact you once a week to check in about your sleep symptoms
After that you will:
-Complete the same activities as you did at the beginning of the study
-Come in six months later to do the activities again
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
An Evaluation of Insomnia Treatment to Reduce Cardiovascular Risk in Patients with Posttraumatic Stress Disorder
Principal Investigator
Jean
Beckham
Protocol Number
PRO00100446
NCT ID
NCT04498754
Phase
N/A
Enrollment Status
OPEN TO ACCRUAL