NightWare and Cardiovascular Health in Women With PTSD
Key facts
- Who runs it
- University of Colorado, Denver
- Where
- Aurora and Denver, United StatesSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 36 people, planned
- Started
- 6 Aug 2025
- Expected to end
- Jul 2028
- Type of study
- Interventional, 3 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- NightWare
- Sham NightWare
- Record updated
- 6 November 2026
Who can take part
- Age
- 22 years to 40 years
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 31 criteriaShow less
Who can take part
- 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
Who cannot take part
- Use of medications that might influence cardiovascular or renal function (i.e., antihypertensive, lipid lowering medications, GLP-1/GIP RAs)
- 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 prior to the first vascular visit
- 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
- Active infection (note, anyone with an active infection would become eligible once the infection has ended)
- 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
- Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy
- 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)
- 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. UCH Clinical Lab ULN for AST and ALT are 39 and 52, respectively. Women with TSH levels outside of the normal range (0.5-5.0 mLU/L) will be referred to their PCP and will be allowed study entry once their TSH levels are normalized > 3 months
- Plasma glucose >126 mg/dl under fasting conditions
- Body Mass Index ≥ 40 kg/m2
- Use of insulin or sulfonylureas
- Pregnant, within 12 months postpartum or currently breast feeding
- 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
- 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 concerns
- Known sleep walking or acting out dreams (contraindication to NightWare use)
- Current or planned participation in an interventional study during the present study
- Participants must have access to wireless internet and two power outlets where they sleep
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 40 years old?
Where in United States
- University of Colorado Anschutz Medical CampusAurora, United StatesContact: Emily A Larson, PhDTaking people
- University of Colorado CCTSI CTRCDenver, United StatesContact: Emily Larson, PhDTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Experimental NightWareTreatment being tested
In women with PTSD-related nightmares randomized to the active condition, when the stress index is reached during sleep, NightWare will intervene with varying degrees of vibratory stimulation to the watch over a variable length of time to arouse the person out of the nightmare without awakening.
Treatment: NightWare
- Sham NightWareSham treatment, for comparison
In women with PTSD-related nightmares randomized to the sham condition, the NightWare intervention will not be enabled
- Control Women without PTSD-related NightmaresNo study treatment, for comparison
Age-matched women without PTSD-related nightmares will complete baseline testing only (no intervention).
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Improving Cardiovascular Health in Women With PTSD by Treating Trauma-Related Nightmares With NightWare
- Fit questions
- Built from NCT07021014, who can take part
- Record updated
- 6 November 2026