NightWare and Cardiovascular Health in Adults With PTSD
Completed · Not applicable · Has a placebo group
Conditions studied: Posttraumatic Stress Disorder, Cardiovascular Diseases, Autonomic Dysfunction, Vascular Stiffness, Nightmare, Endothelial Dysfunction
In brief
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.
Key facts
- Study ID
- NCT05365607
- Run by
- University of Colorado, Denver
- People needed
- 40
- Starts
- 2022-06-24
- Expected to finish
- 2024-08-18
- Last updated by the study team
- 2024-10-08
Who can join
Age: 22 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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;
- Epworth Sleepiness Scale (ESS): Question #8 score above "0" will prompt an additional question: Does individual drive ("get behind the wheel") when they are drowsy? The answer must be "No" to be enrolled in the study due to safety concerns;
- Wireless Internet and two power outlets where they sleep;
- Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare.
You may not qualify if…
- uncontrolled hypertension;
- current or preexisting CVD or cancers (with the exception of past skin cancers) or active infection;
- diabetes;
- thyroid dysfunction, defined as an ultrasensitive TSH <0.5 or >5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement; or other problems that would interfere with participation in the study;
- pregnancy or currently breast feeding;
- current use (or within previous 6 months) of hormone therapy in postmenopausal women;
- current substance (including marijuana) or alcohol use disorder (past 12 months) per the SCID-5 (see methods of Research Strategy). Adults with past substance or alcohol use disorders will be allowed to participate.
- Prazosin use; however, participant may be included if tapered by prescribing provider. Taper must be completed and individual must be off prazosin for 2 days prior to enrollment;
- Participants will be excluded if they report elevated acute risk for suicidal self-directed violence warranting immediate intervention (e.g., suicidal ideation with intent, evaluated by the Columbia-Suicide Severity Rating Scale [C-SSRS]).
- Current use of varenicline, beta-blockers (unless ophthalmic solutions), or non-dihydropyridines;
- Shift workers (due to circadian rhythm disruption);
- Moderate or Severe obstructive sleep apnea (either diagnosed or determined during screening with the WatchPat [AHI≥15];
- Diagnosis of narcolepsy;
- Known sleepwalking;
- Acting out of dreams prior to PTSD trauma; 17) Diagnosis or suspicion of dementia
Where it is running
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- University of Colorado CCTSI CTRC — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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