NightWare and Cardiovascular Health in Women With PTSD

NCT07021014 | Not Yet Recruiting FDA Device

• 1 other identifier: 24-1948
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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; Endothelial Dysfunction; Kidney Diseases; Renal Dysfunction; Trauma and Stressor Related Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

Secondary Outcomes (1)

• Large artery elastic stiffness

  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).

Other Outcomes (12)

• Large artery elastic stiffness-carotid artery

  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).

• Autonomic function-baroreflex sensitivity

  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).

• Autonomic function- heart rate variability

  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).

Study Arms (3)

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.

Device: NightWare

Sham NightWare

SHAM COMPARATOR

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

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).

Interventions

NightWare DEVICE

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.

Experimental NightWare

Sham NightWare DEVICE

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

Sham NightWare

Eligibility Criteria

• Age: 22 Years - 40 Years
• Gender Eligibility Details: cisgender premenopausal women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Ludeman Family Center for Women's Health Research: collaborator

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Colorado CCTSI CTRC

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Cardiovascular Diseases; Primary Dysautonomias; Kidney Diseases; Renal Insufficiency; Trauma and Stressor Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Mental Disorders; Autonomic Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Emily Larson, PhD

CONTACT

7205233224; emily.a2.larson@cuanschutz.edu

Kerrie Moreau, PhD

CONTACT

kerrie.moreau@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)