Cardiovascular Diseases Clinical Trial
Official title:
NightWare Therapeutic Platform for Improving Cardiovascular Health in Adults With Nightmares Associated With PTSD
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. 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). 2. Self-report having repetitive nightmares contributing to disrupted sleep 3. age >22 years (rationale is because the device has only been used in adults in 22 years and older); 4. resting blood pressure (BP, <160/100 mmHg); 5. fasted glucose <126 mg/d; 6. non-smokers; 7. no use of vitamin supplements or anti-inflammatory medications, or willing to stop 1 month prior to the vascular visit; 8. Pittsburgh Sleep Quality Index (PSQI) score 6 or higher; 9. 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; 10. Wireless Internet and two power outlets where they sleep; 11. Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare. Exclusion Criteria: 1. uncontrolled hypertension; 2. current or preexisting CVD or cancers (with the exception of past skin cancers) or active infection; 3. diabetes; 4. 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; 5. pregnancy or currently breast feeding; 6. current use (or within previous 6 months) of hormone therapy in postmenopausal women; 7. 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. 8. 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; 9. 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]). 10. Current use of varenicline, beta-blockers (unless ophthalmic solutions), or non-dihydropyridines; 11. Shift workers (due to circadian rhythm disruption); 12. Moderate or Severe obstructive sleep apnea (either diagnosed or determined during screening with the WatchPat [AHI=15]; 13. Diagnosis of narcolepsy; 14. Known sleepwalking; 16) Acting out of dreams prior to PTSD trauma; 17) Diagnosis or suspicion of dementia |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Anschutz Medical Campus | Aurora | Colorado |
United States | University of Colorado CCTSI CTRC | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in PSQI | sleep questionnaire | Measured before and after 6 weeks of NightWare and sham conditions | |
Other | Change in PSQI-A | sleep questionnaire | Measured before and after 6 weeks of NightWare and sham conditions | |
Other | Change in Epworth sleepiness scale (ESS) | sleep questionnaire | Measured before and after 6 weeks of NightWare and sham conditions | |
Other | Change in CESD | Depression questionnaire | Measured before and after 6 weeks of NightWare and sham conditions | |
Other | Change in SF-36 | Perceived psychosocial and health functioning questionnaire | Measured before and after 6 weeks of NightWare and sham conditions | |
Other | Change in PCL-5 | Presence and severity of PTSD symptoms questionnaire | Measured before and after 6 weeks of NightWare and sham conditions | |
Other | Change in Nightmare disorder index | NDI questionnaire | Measured before and after 6 weeks of NightWare and sham conditions | |
Other | Change in CSSR-S | Suicide risk assessment | Measured before and after 6 weeks of NightWare and sham conditions | |
Other | Change in Norepinephrine | Marker of sympathetic activity | Measured before and after 6 weeks of NightWare and sham conditions | |
Other | Change in Oxidized LDL | Marker of oxidative stress | Measured before and after 6 weeks of NightWare and sham conditions | |
Other | Change in Total antioxidant status | Marker of oxidative stress | Measured before and after 6 weeks of NightWare and sham conditions | |
Other | Change in Interleukin-6 | Marker of inflammation | Measured before and after 6 weeks of NightWare and sham conditions | |
Other | Change in C-Reactive Protein | Marker of inflammation | Measured before and after 6 weeks of NightWare and sham conditions | |
Primary | Change in large elastic artery stiffness -carotid artery | Carotid artery compliance using carotid artery ultrasound | Measured before and after 6 weeks of NightWare and sham conditions | |
Primary | Change in endothelial function | Brachial artery flow-mediated dilation (FMD) using ultrasound | Measured before and after 6 weeks of NightWare and sham conditions | |
Primary | Change in 1utonomic function - BRS | Cardiovagal baroreflex sensitivity (cBRS) | Measured before and after 6 weeks of NightWare and sham conditions | |
Secondary | Change in large elastic artery stiffness | Carotid-femoral pulse wave velocity (PWV) | Measured before and after 6 weeks of NightWare and sham conditions | |
Secondary | Change in autonomic function - HRV | Heart rate variability | Measured before and after 6 weeks of NightWare and sham conditions |
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