RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: NightWare for Post Traumatic Stress Disorder

This study wants 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.

Official registry: https://clinicaltrials.gov/study/NCT07021014 · University of Colorado, Denver · enrollment listed as 36

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are NightWare, or Sham NightWare. The registry lists allocation as randomized. This study wants 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.

They plan to enroll about 36 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

Improving Cardiovascular Health in Women With PTSD by Treating Trauma-Related Nightmares With NightWare

Interventions: NightWare, Sham NightWare

Primary outcome (registry wording): Brachial artery flow-mediated dilation (FMD)

Who it is for (from inclusion criteria)

Ages 22 Years to 40 Years
Women only
Healthy, as determined by medical history
Group Specific Eligibility
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
No lifetime PTSD: screened using PC-PTSD-5

Who the registry excludes

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)
Plasma glucose \>126 mg/dl under fasting conditions
Use of insulin or sulfonylureas
Pregnant, within 12 months postpartum or currently breast feeding

Public study contact (from the registry)

Emily Larson, PhD

7205233224

emily.a2.larson@cuanschutz.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

University of Colorado Anschutz Medical Campus — Aurora, Colorado (recruiting)
University of Colorado CCTSI CTRC — Denver, Colorado (recruiting)

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseChicago, Illinois

Not a traditional drug phase: real iTBS for Mild Traumatic Brain Injury

This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI +/- PTSD.

NCT03819608 · Official ClinicalTrials.gov record · Northwestern University

RecruitingNot a traditional drug phaseLondon, Ontario

Not a traditional drug phase: Deep Brain Reorienting (DBR) for PTSD

This study will measure the how well it works of a therapeutic treatment, Deep Brain Reorienting (DBR), for PTSD (Post-traumatic Stress Disorder). you would be randomly assigned to either the DBR treatment, or wait-list condition.

NCT04317820 · Official ClinicalTrials.gov record · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

RecruitingNot a traditional drug phaseRichmond, Virginia

Not a traditional drug phase: Antioxidant for Peripheral Vascular Diseases

The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).

NCT04916327 · Official ClinicalTrials.gov record · Virginia Commonwealth University

FAQ about this NCT record

Is NCT07021014 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07021014?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07021014?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary