Post Traumatic Stress DisorderNCT07021014
NightWare and Cardiovascular Health in Women With PTSD
A study testing NightWare in people with Post Traumatic Stress Disorder and Cardiovascular Diseases, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Cardiovascular Diseases, Autonomic Dysfunction
- What is being tested?
- NightWare
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Aug 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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 join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kerrie Moreau, PhD contact
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Emily A Larson, PhD, 7205233224, emily.a2.larson@cuanschutz.edu
- Recruiting
University of Colorado CCTSI CTRC
Denver, Colorado, 80045
Emily Larson, PhD, 7205233224, emily.a2.larson@cuanschutz.edu
About this study
Official title: Improving Cardiovascular Health in Women With PTSD by Treating Trauma-Related Nightmares With NightWare
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.
Read the detailed description
Women are disproportionally affected by posttraumatic stress disorder (PTSD), a debilitating mental health disorder that profoundly increases cardiovascular disease (CVD) risk. Biological processes including vascular dysfunction (i.e., impaired endothelial function, arterial stiffening), increased renin-angiotensin-aldosterone system (RAAS) activity, and altered renal vascular control and function may contribute to the pathophysiological link between PTSD and CVD. Sleep is a key regulator of cellular and tissue repair, free radical detoxification, oxidative stress, inflammation, autonomic and endocrine balance and crucial for cardiovascular health. Sleep disturbances due to nightmares are a hallmark symptom of PTSD that cause significant distress and may independently contribute to elevated CVD risk in individuals with PTSD. As such, interventions aimed at treating trauma-related nightmares are a promising therapeutic approach in ameliorating the cardiovascular consequences of PTSD.
NightWare™, a smart-watch based application that uses biometric data and vibrotactile feedback to disrupt nightmares, is an FDA approved digital therapeutic system for the treatment of nightmares in adults (≥22 years) with PTSD. While a preliminary study demonstrated that 30 days of NightWare treatment improved subjective sleep quality in Veterans, the influence of NightWare treatment on vascular and renal function in young women with PTSD-related nightmares is unknown. These investigations are critical among women who, despite having 2x greater prevalence of PTSD compared to men, and a differential progression of PTSD, CVD, and chronic kidney disease (CKD), are underrepresented in the literature.
Accordingly, the investigators will examine if the NightWare digital therapeutic system improves vascular and renal function in premenopausal women with PTSD-related nightmares, and whether these improvements restore them to levels observed in age-matched women without PTSD. We will employ 1) cross-sectional comparisons between two groups of women: those with PTSD and nightmares (PTSD group) and those without PTSD and nightmares (age-matched control group); and 2) a short-term (8-week) NightWare or sham intervention in women with nightmares related to PTSD.
- Conditions
- Post Traumatic Stress Disorder, Cardiovascular Diseases, Autonomic Dysfunction, Vascular Stiffness, Nightmare, Endothelial Dysfunction
- Being tested
- NightWare, Sham NightWare
- Keywords
- Sleep, Trauma and Stressor Related Disorders, Post Traumatic Stress Disorder, Cardiovascular Diseases, Kidney Diseases, Renal Dysfunction, Autonomic Dysfunction
- Medical subject headings
- Stress Disorders, Post-Traumatic, Cardiovascular Diseases, Primary Dysautonomias, Kidney Diseases, Renal Insufficiency, Trauma and Stressor Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NightWareDevice
A wearable digital therapeutic platform consisting of an Apple Watch and iPhone pre-provisioned with Nightware intervention app that will deliver a mild vibration to the watch after detecting individual having a nightmare based on Nightware proprietary algorithm, arousing the individual and disrupting nightmare without awakening.
Sham NightWareDevice
NightWare decive will not deliver an intervention (i.e., no vibration)
| Study group | Role | What they receive |
|---|---|---|
| Experimental NightWare | Experimental | 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. Receives: Device: NightWare |
| Sham NightWare | Sham comparator | In women with PTSD-related nightmares randomized to the sham condition, the NightWare intervention will not be enabled Receives: Device: Sham NightWare |
| Control Women without PTSD-related Nightmares | No intervention | Age-matched women without PTSD-related nightmares will complete baseline testing only (no intervention). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow-mediated dilation (FMD)
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.
Measured: PTSD vs controls at baseline. In PTSD group only, change with NightWare vs Sham (measured pre and post-intervention 8 weeks of NightWare or sham conditions).
Secondary outcomes (1)
Large artery elastic stiffness
Carotid-femoral pulse wave velocity (PWV). A higher number is a general indicator of worse vascular function.
Measured: PTSD vs controls at baseline. In PTSD group only, change with NightWare vs Sham (measured pre and post-intervention 8 weeks of NightWare or sham conditions).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start6 Aug 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Observational study (women with PTSD-related nightmares vs control group without PTSD-related nightmares); In women with PTSD-related nightmares only: randomized, double-blind, placebo (i.e., sham intervention) controlled parallel pilot study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Ludeman Family Center for Women's Health Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021014
- Sponsor's protocol ID
- 24-1948
- Status last verified
- Nov 2026
- First submitted
- 5 Jun 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cardiovascular Health in Women With PTSD by Treating Trauma-Related Nightmares With NightWare
- ClinicalTrials.gov ID
- NCT07021014
- Acronym / sponsor ID
- 24-1948
- Conditions
- Post Traumatic Stress Disorder, Cardiovascular Diseases, Autonomic Dysfunction, Vascular Stiffness, Nightmare, Endothelial Dysfunction
- Keywords
- Sleep, Trauma and Stressor Related Disorders, Post Traumatic Stress Disorder, Cardiovascular Diseases, Kidney Diseases, Renal Dysfunction, Autonomic Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Ludeman Family Center for Women's Health Research
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Women are disproportionally affected by posttraumatic stress disorder (PTSD), a debilitating mental health disorder that profoundly increases cardiovascular disease (CVD) risk. Biological processes including vascular dysfunction (i.e., impaired endothelial function, arterial stiffening), increased renin-angiotensin-aldosterone system (RAAS) activity, and altered renal vascular control and function may contribute to the pathophysiological link between PTSD and CVD. Sleep is a key regulator of cellular and tissue repair, free radical detoxification, oxidative stress, inflammation, autonomic and endocrine balance and crucial for cardiovascular health. Sleep disturbances due to nightmares are a hallmark symptom of PTSD that cause significant distress and may independently contribute to elevated CVD risk in individuals with PTSD. As such, interventions aimed at treating trauma-related nightmares are a promising therapeutic approach in ameliorating the cardiovascular consequences of PTSD.
NightWare™, a smart-watch based application that uses biometric data and vibrotactile feedback to disrupt nightmares, is an FDA approved digital therapeutic system for the treatment of nightmares in adults (≥22 years) with PTSD. While a preliminary study demonstrated that 30 days of NightWare treatment improved subjective sleep quality in Veterans, the influence of NightWare treatment on vascular and renal function in young women with PTSD-related nightmares is unknown. These investigations are critical among women who, despite having 2x greater prevalence of PTSD compared to men, and a differential progression of PTSD, CVD, and chronic kidney disease (CKD), are underrepresented in the literature.
Accordingly, the investigators will examine if the NightWare digital therapeutic system improves vascular and renal function in premenopausal women with PTSD-related nightmares, and whether these improvements restore them to levels observed in age-matched women without PTSD. We will employ 1) cross-sectional comparisons between two groups of women: those with PTSD and nightmares (PTSD group) and those without PTSD and nightmares (age-matched control group); and 2) a short-term (8-week) NightWare or sham intervention in women with nightmares related to PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Observational study (women with PTSD-related nightmares vs control group without PTSD-related nightmares); In women with PTSD-related nightmares only: randomized, double-blind, placebo (i.e., sham intervention) controlled parallel pilot study
| Arm | Type | Receives |
|---|---|---|
| Experimental NightWare | Experimental | Device: NightWareIn 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. |
| Sham NightWare | Sham comparator | Device: Sham NightWareIn women with PTSD-related nightmares randomized to the sham condition, the NightWare intervention will not be enabled |
| Control Women without PTSD-related Nightmares | No intervention | –Age-matched women without PTSD-related nightmares will complete baseline testing only (no intervention). |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NightWareA wearable digital therapeutic platform consisting of an Apple Watch and iPhone pre-provisioned with Nightware intervention app that will deliver a mild vibration to the watch after detecting individual having a nightmare based on Nightware proprietary algorithm, arousing the individual and disrupting nightmare without awakening. | Device | Experimental NightWare |
| Sham NightWareNightWare decive will not deliver an intervention (i.e., no vibration) | Device | Sham NightWare |
Primary outcome
Brachial artery flow-mediated dilation (FMD)
Time frame: PTSD vs controls at baseline. In PTSD group only, change with NightWare vs Sham (measured pre and post-intervention 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.
1 secondary outcome
Large artery elastic stiffness
Time frame: PTSD vs controls at baseline. In PTSD group only, change with NightWare vs Sham (measured pre and post-intervention 8 weeks of NightWare or sham conditions).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kerrie Moreau, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NightWare in people with Post Traumatic Stress Disorder and Cardiovascular Diseases, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Larson, PhD (7205233224, emily.a2.larson@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial artery flow-mediated dilation (FMD) (time frame: PTSD vs controls at baseline. In PTSD group only, change with NightWare vs Sham (measured pre and post-intervention 8 weeks of NightWare or sham conditions).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.