Recruiting

NightWare

Sponsor:

University of Colorado, Denver

Code:

NCT07021014

Conditions

Post Traumatic Stress Disorder

Cardiovascular Diseases

Autonomic Dysfunction

Vascular Stiffness

Nightmare

Eligibility Criteria

Sex: Female

Age: 22 - 40

Healthy Volunteers: Accepted

Interventions

NightWare

Sham NightWare

Study Details

Brief 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.

Conditions

Post Traumatic Stress Disorder

Cardiovascular Diseases

Autonomic Dysfunction

Vascular Stiffness

Nightmare

Study ID

NCT07021014

Start date

Aug 6, 2025

Status verified date

Nov, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22 - 40

Healthy Volunteers: Accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental NightWare

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.

sham comparator: Sham NightWare

In women with PTSD-related nightmares randomized to the sham condition, the NightWare intervention will not be enabled

no intervention: Control Women without PTSD-related Nightmares

Age-matched women without PTSD-related nightmares will complete baseline testing only (no intervention).

Interventions

NightWare

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 NightWare

NightWare decive will not deliver an intervention (i.e., no vibration)

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). ]

Central Contacts and Locations

Central contacts

Emily Larson, PhD

7205233224emily.a2.larson@cuanschutz.edu

Kerrie Moreau, PhD

kerrie.moreau@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Emily A Larson, PhD

7205233224emily.a2.larson@cuanschutz.edu

University of Colorado CCTSI CTRC

Recruiting

Denver, Colorado, United States, 80045

Contacts

Emily Larson, PhD

7205233224emily.a2.larson@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Nov 6, 2026

Last verified

Nov, 2026

Keywords

  • Sleep
  • Trauma and Stressor Related Disorders
  • Post Traumatic Stress Disorder
  • Cardiovascular Diseases
  • Kidney Diseases
  • Renal Dysfunction
  • Autonomic Dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-07. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-11-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.