NightWare and Cardiovascular Health in Women With PTSD

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22-40
SponsorUniversity of Colorado, Denver

About this trial

The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular and renal function in premenopausal women with PTSD-related nightmares, and examine whether these improvements restore them to levels observed in age-matched women without PTSD.

Eligibility criteria

Qualifiers

Healthy, as determined by medical history

Group Specific Eligibility

PTSD Group

Lifetime PTSD: screened using Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and confirmed via Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

Disqualifiers

Pre-existing (e.g., diabetes, liver, kidney disease) or unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer) or systemic illness that would interfere with interpretation of the study outcomes

Body Mass Index ≥ 40 kg/m2

Use of medications that might influence cardiovascular or renal function (i.e., antihypertensive, lipid lowering medications, GLP-1/GIP RAs)

Active infection (note, anyone with an active infection would become eligible once the infection has ended)

Trial design

Treatments tested in this trial

  • NightWare
  • Sham NightWare

Treatment groups

36 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Colorado, Denver

Lead sponsor

Ludeman Family Center for Women's Health Research

Collaborator