Cardiovascular Diseases Clinical Trial
Official title:
Improving Cardiovascular Health in Veterans With PTSD by Treating Trauma-Related Nightmares With NightWare
The purpose of this study is to learn more about the effectiveness of a prescription wrist-wearable device called NightWare (NW) on improving sleep in Veterans with nightmares related to posttraumatic stress disorder (PTSD). The investigators also want to learn whether it improves cardiovascular health among this population.
Status | Not yet recruiting |
Enrollment | 125 |
Est. completion date | September 30, 2026 |
Est. primary completion date | September 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years to 88 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/dL; 6. Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher; 7. Epworth Sleepiness Scale (ESS): 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; 8. Wireless Internet and two power outlets in sleeping location; 9. 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. Unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer); 2. Active infection (note, anyone with an active infection would become eligible once the infection has ended); 3. 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; 4. Use of insulin or sulfonylureas 5. Pregnancy or currently breast feeding; 6. Current history (past 3 months) of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate; 7. Participants will be excluded if they report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the Columbia-Suicide Severity Rating Scale [C-SSRS]). 8. Shift workers (due to circadian rhythm disruption); 9. Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy; 10. Nocturia that causes awakening from sleep; 11. Known sleep walking or acting out dreams (contraindication to NW use); 12. Diagnosis or suspicion of dementia; 13. Seizure disorder 14. Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal) |
Country | Name | City | State |
---|---|---|---|
United States | Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Pittsburgh Sleep Quality Index | Sleep questionnaire with a scale of 0 to 21 with a higher score indicating a significant sleep disturbance | Measured before and after 8 weeks of NightWare and sham conditions | |
Secondary | Change in physiological sleep - total sleep time | Total sleep duration (minutes) calculated through ambulatory electroencephalography. | Measured before and after 8 weeks of NightWare and sham conditions | |
Secondary | Change in endothelial function | Brachial artery flow mediated dilation (FMD) using ultrasound | Measured before and after 8 weeks of NightWare and sham conditions | |
Secondary | Change in Autonomic function - spontaneous baroreflex sensitivity (BRS) | Cardiovagal baroreflex sensitivity (cBRS) measured using beat-to-beat time series of systolic blood pressures (finger photo-plethysmography) and R-R interval (three-lead electrocardiogram) will be recorded simultaneously at 1,000 Hz. | Measured before and after 8 weeks of NightWare and sham conditions | |
Secondary | Change in large elastic artery stiffness | Carotid-femoral pulse wave velocity (PWV) | Measured before and after 8 weeks of NightWare and sham conditions | |
Secondary | Change in large elastic artery stiffness | Augmentation index and aortic blood pressure via pulse wave analysis | Measured before and after 8 weeks of NightWare and sham conditions | |
Secondary | Change in autonomic function - heart rate variability (HRV) | Heart rate variability | Measured before and after 8 weeks of NightWare and sham conditions | |
Secondary | Change in physiological sleep - wake after sleep onset | Wake after sleep (minutes) calculated through ambulatory electroencephalography. | Measured before and after 8 weeks of NightWare and sham conditions | |
Secondary | Change in physiological sleep - sleep efficiency | Sleep efficiency (percentage) calculated through ambulatory electroencephalography. | Measured before and after 8 weeks of NightWare and sham conditions | |
Secondary | Change in physiological sleep - REM sleep | REM sleep (minutes) calculated through ambulatory electroencephalography. | Measured before and after 8 weeks of NightWare and sham conditions | |
Secondary | Change in physiological sleep - Deep sleep | Deep sleep (minutes) calculated through ambulatory electroencephalography. | Measured before and after 8 weeks of NightWare and sham conditions | |
Secondary | Change in physiological sleep - Light sleep | Light sleep (minutes) calculated through ambulatory electroencephalography. | Measured before and after 8 weeks of NightWare and sham conditions |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Recruiting |
NCT04417387 -
The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
|
||
Not yet recruiting |
NCT06211361 -
Cardiac Rehabilitation Program in Patients With Cardiovascular Disease
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04514445 -
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
|
||
Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Completed |
NCT04083872 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)
|
Phase 1 | |
Completed |
NCT04083846 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
|
Phase 1 | |
Completed |
NCT03466333 -
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
|
Phase 2 | |
Completed |
NCT03693365 -
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
|
||
Completed |
NCT03619148 -
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT05132998 -
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|