Insomnia PTSD

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

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?

Description

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 begin reporting on your sleep each day and get a random assignment (like a coin flip) to 1 of 2 groups:
  • 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 Enrollment
    ClinicalTrials.gov