Post Traumatic Stress Disorder study: NightWare
Official title NightWare and Cardiovascular Health in Women With PTSD
ClinicalTrials.gov ID: NCT07021014
What this study is testing
- What it's testing
- The purpose of this study is to find out 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 40, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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)
- Prior trauma exposure: screened using Brief Trauma Questionnaire (BTQ)
You likely can't join if
- Pre-existing (e.g., diabetes, liver, kidney disease) or unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer) or...
- 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)
- Abnormal thyroid, liver, or kidney function testing during the screening examination or bloodwork.
- Plasma glucose \>126 mg/dl under fasting conditions
See the full eligibility criteria
- 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)
- Prior trauma exposure: screened using Brief Trauma Questionnaire (BTQ)
- Self-report having repetitive nightmares contributing to disrupted sleep
- Poor overall sleep quality: PSQI score 6 or higher
- Control Group
- No lifetime PTSD: screened using PC-PTSD-5
- No prior trauma exposure: screened using BTQ
- Do not self-report having repetitive nightmares contributing to disturbed sleep
- 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...
- 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)
- Abnormal thyroid, liver, or kidney function testing during the screening examination or bloodwork. Abnormal kidney function defined as creatinine \>1.3mg/dL. Abnormal liver function tests within 1.5x ULN.
- Plasma glucose \>126 mg/dl under fasting conditions
- Use of insulin or sulfonylureas
- Pregnant, within 12 months postpartum or currently breast feeding
- Current history of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate.
- Report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the C-SSRS).
- Shift workers
- Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy
- Nocturia that causes awakening from sleep
- Epworth Sleepiness Scale: Question #8 score above "0" will prompt an additional question: Do you drive ("get behind the wheel") when you are drowsy? The answer must be "No" to be enrolled in the study due to safety...
- Known sleep walking or acting out dreams (contraindication to NightWare use)
- Diagnosis or suspicion of dementia
- Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)
- Current use of vitamin/supplements (including melatonin) or anti-inflammatory medications, participants will be included if they are willing to stop taking vitamin/supplements or anti-inflammatory medications 2 weeks...
- Current or planned participation in an treatment study during the present study
- Participants must have access to wireless internet and two power outlets where they sleep
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
- Denver, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 22 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States; Denver, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.