CompletedNot Applicable

NightWare and Cardiovascular Health in Adults With PTSD

United States40 participantsStarted 2022-06-24

Plain-language summary

The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular aging and autonomic function in adults with nightmares related to PTSD.

Who can participate

Age range

22 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
. Self-report having repetitive nightmares contributing to disrupted sleep
. age \>22 years (rationale is because the device has only been used in adults in 22 years and older);
. resting blood pressure (BP, \<160/100 mmHg);
. fasted glucose \<126 mg/d;
. non-smokers;
. no use of vitamin supplements or anti-inflammatory medications, or willing to stop 1 month prior to the vascular visit;
. Pittsburgh Sleep Quality Index (PSQI) score 6 or higher;

Exclusion criteria

. uncontrolled hypertension;
. current or preexisting CVD or cancers (with the exception of past skin cancers) or active infection;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in large elastic artery stiffness -carotid artery

Timeframe: Measured before and after 6 weeks of NightWare and sham conditions

Change in endothelial function

Timeframe: Measured before and after 6 weeks of NightWare and sham conditions

Change in 1utonomic function - BRS

Timeframe: Measured before and after 6 weeks of NightWare and sham conditions

Trial details

NCT IDNCT05365607

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-15

View on ClinicalTrials.gov More Posttraumatic Stress Disorder trials

Who can participate

Age range

22 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
. Self-report having repetitive nightmares contributing to disrupted sleep
. age \>22 years (rationale is because the device has only been used in adults in 22 years and older);
. resting blood pressure (BP, \<160/100 mmHg);
. fasted glucose \<126 mg/d;
. non-smokers;
. no use of vitamin supplements or anti-inflammatory medications, or willing to stop 1 month prior to the vascular visit;
. Pittsburgh Sleep Quality Index (PSQI) score 6 or higher;

Exclusion criteria

. uncontrolled hypertension;
. current or preexisting CVD or cancers (with the exception of past skin cancers) or active infection;

What they're measuring

Change in large elastic artery stiffness -carotid artery

Timeframe: Measured before and after 6 weeks of NightWare and sham conditions

Change in endothelial function

Timeframe: Measured before and after 6 weeks of NightWare and sham conditions

Change in 1utonomic function - BRS

Timeframe: Measured before and after 6 weeks of NightWare and sham conditions