NightWare and Cardiovascular Health in Women With PTSD
A legfontosabb adatok
- Ki végzi
- University of Colorado, Denver
- Hol
- Aurora és Denver (Egyesült Államok)Mind a 2 helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 36 fő, tervezett
- Kezdés
- 2025. aug. 6.
- Várható befejezés
- 2028. júl.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoportAz egyik csoport színlelt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- NightWare
- Sham NightWare
- A regiszteradat frissítve
- 2026. november 6.
Ki vehet részt
- Életkor
- 22 év – 40 év
- Nem
- Csak nők
- Egészséges önkéntesek
- Részt vehetnek
A regiszter feltételei, szó szerint
Mind a 31 feltétel megnézéseKevesebb
Ki vehet részt
- Healthy, as determined by medical history
- Group Specific Eligibility
- PTSD Group
- Lifetime PTSD: screened using Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and confirmed via Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
- Prior trauma exposure: screened using Brief Trauma Questionnaire (BTQ)
- Self-report having repetitive nightmares contributing to disrupted sleep
- Poor overall sleep quality: PSQI score 6 or higher
- Control Group
- No lifetime PTSD: screened using PC-PTSD-5
- No prior trauma exposure: screened using BTQ
- Do not self-report having repetitive nightmares contributing to disturbed sleep
Ki nem vehet részt
- Use of medications that might influence cardiovascular or renal function (i.e., antihypertensive, lipid lowering medications, GLP-1/GIP RAs)
- Current use of vitamin/supplements (including melatonin) or anti-inflammatory medications, participants will be included if they are willing to stop taking vitamin/supplements or anti-inflammatory medications 2 weeks prior to the first vascular visit
- Pre-existing (e.g., diabetes, liver, kidney disease) or unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer) or systemic illness that would interfere with interpretation of the study outcomes
- Active infection (note, anyone with an active infection would become eligible once the infection has ended)
- Current history of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate
- Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy
- Diagnosis or suspicion of dementia
- Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)
- Abnormal thyroid, liver, or kidney function testing during the screening examination or bloodwork. Abnormal kidney function defined as creatinine >1.3mg/dL. Abnormal liver function tests within 1.5x ULN. UCH Clinical Lab ULN for AST and ALT are 39 and 52, respectively. Women with TSH levels outside of the normal range (0.5-5.0 mLU/L) will be referred to their PCP and will be allowed study entry once their TSH levels are normalized > 3 months
- Plasma glucose >126 mg/dl under fasting conditions
- Body Mass Index ≥ 40 kg/m2
- Use of insulin or sulfonylureas
- Pregnant, within 12 months postpartum or currently breast feeding
- Report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the C-SSRS)
- Shift workers
- Nocturia that causes awakening from sleep
- Epworth Sleepiness Scale: 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
- Known sleep walking or acting out dreams (contraindication to NightWare use)
- Current or planned participation in an interventional study during the present study
- Participants must have access to wireless internet and two power outlets where they sleep
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 22 és 40 év között vagy?
Helyszínek itt: Egyesült Államok
- University of Colorado Anschutz Medical CampusAurora, Egyesült ÁllamokContact: Emily A Larson, PhDRésztvevőt keres
- University of Colorado CCTSI CTRCDenver, Egyesült ÁllamokContact: Emily Larson, PhDRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular and renal function in premenopausal women with PTSD-related nightmares, and examine whether these improvements restore them to levels observed in age-matched women without PTSD.
A vizsgálat 3 csoportja
- Experimental NightWareA vizsgált kezelés
In women with PTSD-related nightmares randomized to the active condition, when the stress index is reached during sleep, NightWare will intervene with varying degrees of vibratory stimulation to the watch over a variable length of time to arouse the person out of the nightmare without awakening.
Kezelés: NightWare
- Sham NightWareSzínlelt kezelés, összehasonlításként
In women with PTSD-related nightmares randomized to the sham condition, the NightWare intervention will not be enabled
- Control Women without PTSD-related NightmaresNincs vizsgálati kezelés, összehasonlításként
Age-matched women without PTSD-related nightmares will complete baseline testing only (no intervention).
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Improving Cardiovascular Health in Women With PTSD by Treating Trauma-Related Nightmares With NightWare
- Illeszkedési kérdések
- Forrás: NCT07021014: ki vehet részt
- A regiszteradat frissítve
- 2026. november 6.