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NightWare for PTSD-Related Nightmares and Cardiovascular Health in Women

This study is looking at how NightWare, a wearable device that uses mild vibrations to interrupt nightmares, might improve heart and blood vessel health in women with Post-Traumatic Stress Disorder (PTSD) who experience nightmares. Researchers want to see if NightWare can help restore these health markers to levels seen in women without PTSD. You could be eligible if you are a woman between 22 and 40 years old, are generally healthy, and have been diagnosed with PTSD and experience repetitive nightmares. The study will measure changes in how well your blood vessels expand (called brachial artery flow-mediated dilation or FMD) after using NightWare or a sham device for 8 weeks to see if it's successful. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 36 women. Participants will either receive NightWare or a sham NightWare device, which does not deliver vibrations.
What's involved
Participants will use either NightWare or a sham device for 8 weeks. Measurements of blood vessel function will be taken before and after this 8-week period.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07021014

NightWare and Cardiovascular Health in Women With PTSD

Not Yet Recruiting
NAAges 22–40InterventionalTreatment
University of Colorado, Denver
~36 participants
Updated 2025-06-13 on ClinicalTrials.gov
What's tested:NightWareSham NightWare

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Brachial artery flow-mediated dilation (FMD)
Measured over PTSD vs controls at baseline. In PTSD group only, change with NightWare vs Sham (measured before and after 8 weeks of NightWare or sham conditions).

Conditions

Post Traumatic Stress Disorder
Cardiovascular Diseases
Autonomic Dysfunction
Vascular Stiffness
Nightmare
Endothelial Dysfunction
Kidney Diseases
Renal Dysfunction
Trauma and Stressor Related Disorders

Explore related trials

Cardiovascular DisorderNephropathyNightmarePost-Traumatic Stress DisorderSleep Disorder

Where it's being run

2 sites across 1 states
Colorado2

Who to contact

Emily Larson, PhD
[email protected]
7205233224
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

Exclusion

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)
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
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 concerns
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 prior to the first vascular visit.
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

What this trial measures

  • Brachial artery flow-mediated dilation (FMD)PTSD vs controls at baseline. In PTSD group only, change with NightWare vs Sham (measured before and after 8 weeks of NightWare or sham conditions).

    FMD of the brachial artery, calculated as a percentage, is an index of vascular function. A higher number is a general indicator of better vascular function.