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New treatment option for Post-traumatic Stress Disorder (PTSD)
Official title NightWare and Cardiovascular Health in Veterans With PTSD
ClinicalTrials.gov ID: NCT06419959
What this study is testing
- What it's testing
- 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.
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 PTSD via American Psychiatric Association PTSD diagnostic criteria in the fifth edition of its Diagnostic and Statistical Manual of...
- 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/dL;
You likely can't join if
- Unstable medical condition (e.g., uncontrolled hypertension or active 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 TSH \ 5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the...
- 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...
See the full eligibility criteria
- 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/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 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 TSH \ 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...
- 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 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's taking place
- 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 - 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?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.