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NightWare and Cardiovascular Health in Veterans With PTSD
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.
Conditions:
🦠 Post-traumatic Stress Disorder (PTSD) 🦠 Cardiovascular Diseases 🦠 Autonomic Dysfunction 🦠 Vascular Stiffness 🦠 Nightmare 🦠 Endothelial Dysfunction 🦠 Veteran
🗓️ Study Start (Actual) 1 October 2024
🗓️ Primary Completion (Estimated) 30 September 2026
✅ Study Completion (Estimated) 30 September 2026
👥 Enrollment (Estimated) 125
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Aurora, Colorado, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 22 Years to 88 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 May 2024
  • First Submitted that Met QC Criteria 14 May 2024
  • First Posted 17 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 May 2024
  • Last Update Posted 17 May 2024
  • Last Verified May 2024