Post-traumatic Stress Disorder study: NightWare
Official title NightWare and Cardiovascular Health in Veterans With PTSD
ClinicalTrials.gov ID: NCT06419959
What this study is testing
- What it's testing
- This study aims to find out if a prescription wrist device called NightWare improves sleep for veterans with PTSD-related nightmares. It also checks if the device has any effect on heart health.
- Who it's for
- The study is looking for veterans who have post-traumatic stress disorder (PTSD) and experience nightmares.
- What's involved
- Participants will use a prescription wrist-wearable device to help with sleep. They will also undergo tests to check their heart health.
- Time commitment
- The source text does not specify the duration of the study or the number of visits required.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 88. Healthy volunteers may be eligible.
You may be able to join if
- Diagnosis of Post-traumatic stress disorder (PTSD) via American Psychiatric Association PTSD diagnostic criteria in the fifth edition of its...
- Self-report having repetitive nightmares contributing to disrupted sleep
- Resting blood pressure (BP, \<160/100 millimeters of mercury (mmHg)
- Fasted glucose \<126 milligrams per deciliter (mg/dL)
- Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher
You likely can't join if
- Unstable medical condition (e.g., uncontrolled hypertension or active Cardiovascular disease (CVD) or cancer)
- Active infection (note, anyone with an active infection would become eligible once the infection has ended)
- Thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH)\ 5.0 milliunits per liter (mU/L)
- Use of insulin or sulfonylureas
- Pregnancy or currently breast feeding
- Current history (past 3 months) of substance (excluding marijuana) or alcohol abuse per the SCID-5.
See the full eligibility criteria
- Diagnosis of Post-traumatic stress disorder (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
- Resting blood pressure (BP, \<160/100 millimeters of mercury (mmHg)
- Fasted glucose \<126 milligrams per deciliter (mg/dL)
- Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher
- 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...
- Wireless Internet and two power outlets in sleeping location
- Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare
- Unstable medical condition (e.g., uncontrolled hypertension or active Cardiovascular disease (CVD) or cancer)
- Active infection (note, anyone with an active infection would become eligible once the infection has ended)
- Thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH)\ 5.0 milliunits per liter (mU/L)
- Use of insulin or sulfonylureas
- Pregnancy or currently breast feeding
- 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
- 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...
- Shift workers (due to circadian rhythm disruption)
- Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy;
- Nocturia that causes awakening from sleep
- Known sleep walking or acting out dreams (contraindication to NightWare (NW) use)
- Diagnosis or suspicion of dementia
- Seizure disorder
- Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 88 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.