- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06419959
NightWare e salute cardiovascolare nei veterani con disturbo da stress post-traumatico
Migliorare la salute cardiovascolare nei veterani affetti da disturbo da stress post-traumatico trattando gli incubi legati ai traumi con 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Posttraumatic stress disorder (PTSD) is associated with profound health consequences in Veterans, including cardiovascular disease (CVD), the leading cause of death in adults in the United States. Trauma-related nightmares, a hallmark of PTSD, are a debilitating symptom that can lead to poor sleep quality and other health issues that ultimately cause clinically significant impairments in daily functioning. Recently, nightmares were reported to be an independent predictor of CVD in Veterans, for reasons that are unclear. Poor sleep is associated with increased CVD risk, possibly by impairing vascular health and nervous system function. Nightmare-related sleep disturbances are often resistant to first-line treatment (e.g., psychotherapy, medications) and even with improvements, residual nightmares and sleep disturbances often persist that still meet clinical significance. Moreover, significant barriers often exist including access to care and lack of trained providers, that prevent reaching and engagement of individuals to treatments, and there is poor adherence to interventions overall. As such, there is a need to implement interventions and/or complementary approaches that may appeal to Veterans experiencing PTSD-related nightmares who are looking for alternatives. In this regard, NightWare (NW) digital therapeutic is a novel smart watch application that was recently granted Breakthrough Device designation by the FDA for the treatment of nightmares in adults with PTSD. It uses the wearer's biometric data (i.e., heart rate, body movement and position) to distinguish normal and distressed sleep and interrupt nightmares. Preliminary evidence demonstrated an improvement in subjective sleep quality in Veterans after 30-days of NW compared with a sham condition. However, it is unknown whether NW improves sleep quality in Veterans with PTSD with co-morbid medical conditions such as obstructive sleep apnea (OSA) or in those using medications (e.g., prazosin) to treat nightmares related to PTSD. It is also unknown if the effects of NW on sleep are similar in male and female Veterans, or whether improvements in sleep with NW result in improvements in objective sleep (i.e., sleep physiology) or cardiovascular health. In this context, this study will determine if 8 weeks of NW improves subjective sleep in Veterans with PTSD-related nightmares, including those with OSA and/or taking medications to treat PTSD related nightmares (e.g., prazosin). The change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 8 weeks will be measured. Additional goals will evaluate changes in cardiovascular health outcomes with NW use and if there are potential sex differences in the response to NW. The proposed research is a high priority topic of the Veterans Affairs, as PTSD affects 11-23% of Veterans in a given year. The research is highly innovative and if successful will lead to significant advances in the healthcare of Veterans, particularly as it relates to the treatment of PTSD-related nightmares.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Kerrie L Moreau, PhD
- Numero di telefono: (720) 885-1950
- Email: Kerrie.Moreau@va.gov
Backup dei contatti dello studio
- Nome: Claire Cox, BS
- Numero di telefono: (303) 372-1396
- Email: claire.cox@va.gov
Luoghi di studio
-
-
Colorado
-
Aurora, Colorado, Stati Uniti, 80045-7211
- Reclutamento
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
Investigatore principale:
- Kerrie L Moreau, PhD
-
Contatto:
- Claire Cox, BS
- Numero di telefono: (303) 372-1396
- Email: claire.cox@va.gov
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion 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 safety concerns
- 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
Exclusion Criteria:
- 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)<0.5 or >5.0 milliunits per liter (mU/L); volunteers with abnormal thyroid stimulating hormone (TSH) values will be re-considered for participation in the study after follow-up evaluation by the Primary Care Provider (PCP) with initiation or adjustment of thyroid hormone replacement; or other problems that would interfere with participation in the study
- 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 Rating Scale [C-SSRS])
- 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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: NightWare active
Intervention with NightWare Therapeutic System |
Nightware intervention app (enabled) will attempt to detect when an individual is having a nightmare based on a Nightware proprietary algorithm and attempt to disrupt the nightmare without awakening. In the sham comparator group the NightWare app will be disabled and not deliver an intervention. |
|
Comparatore fittizio: NightWare Sham
NightWare app disabled; device will not deliver an intervention |
Nightware intervention app (enabled) will attempt to detect when an individual is having a nightmare based on a Nightware proprietary algorithm and attempt to disrupt the nightmare without awakening. In the sham comparator group the NightWare app will be disabled and not deliver an intervention. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Pittsburgh Sleep Quality Index
Lasso di tempo: Measured before and after 8 weeks of NightWare and sham conditions
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in physiological sleep - total sleep time
Lasso di tempo: Measured before and after 8 weeks of NightWare and sham conditions
|
Total sleep duration (minutes) calculated through ambulatory electroencephalography. |
Measured before and after 8 weeks of NightWare and sham conditions
|
|
Change in endothelial function
Lasso di tempo: Measured before and after 8 weeks of NightWare and sham conditions
|
Brachial artery flow mediated dilation (FMD) using ultrasound |
Measured before and after 8 weeks of NightWare and sham conditions
|
|
Change in Autonomic function - spontaneous baroreflex sensitivity (BRS)
Lasso di tempo: Measured before and after 8 weeks of NightWare and sham conditions
|
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
|
|
Change in large elastic artery stiffness
Lasso di tempo: Measured before and after 8 weeks of NightWare and sham conditions
|
Carotid-femoral pulse wave velocity (PWV) |
Measured before and after 8 weeks of NightWare and sham conditions
|
|
Change in large elastic artery stiffness
Lasso di tempo: Measured before and after 8 weeks of NightWare and sham conditions
|
Augmentation index and aortic blood pressure via pulse wave analysis |
Measured before and after 8 weeks of NightWare and sham conditions
|
|
Change in autonomic function - heart rate variability (HRV)
Lasso di tempo: Measured before and after 8 weeks of NightWare and sham conditions
|
Heart rate variability |
Measured before and after 8 weeks of NightWare and sham conditions
|
|
Change in physiological sleep - wake after sleep onset
Lasso di tempo: Measured before and after 8 weeks of NightWare and sham conditions
|
Wake after sleep (minutes) calculated through ambulatory electroencephalography. |
Measured before and after 8 weeks of NightWare and sham conditions
|
|
Change in physiological sleep - sleep efficiency
Lasso di tempo: Measured before and after 8 weeks of NightWare and sham conditions
|
Sleep efficiency (percentage) calculated through ambulatory electroencephalography. |
Measured before and after 8 weeks of NightWare and sham conditions
|
|
Change in physiological sleep - REM sleep
Lasso di tempo: Measured before and after 8 weeks of NightWare and sham conditions
|
REM sleep (minutes) calculated through ambulatory electroencephalography. |
Measured before and after 8 weeks of NightWare and sham conditions
|
|
Change in physiological sleep - Deep sleep
Lasso di tempo: Measured before and after 8 weeks of NightWare and sham conditions
|
Deep sleep (minutes) calculated through ambulatory electroencephalography. |
Measured before and after 8 weeks of NightWare and sham conditions
|
|
Change in physiological sleep - Light sleep
Lasso di tempo: Measured before and after 8 weeks of NightWare and sham conditions
|
Light sleep (minutes) calculated through ambulatory electroencephalography. |
Measured before and after 8 weeks of NightWare and sham conditions
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Kerrie L Moreau, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Disturbi da stress, traumatici
- Condizioni patologiche, segni e sintomi
- Disturbi correlati a traumi e fattori di stress
- Malattia cardiovascolare
- Disordini mentali
- Infiammazione
- Malattie del sistema nervoso
- Disturbi da stress, post-traumatici
- Malattie del sistema nervoso autonomo
- Disautonomi primarie
Altri numeri di identificazione dello studio
- CARB-005-23F
- CX002762-01A1 (Altro numero di sovvenzione/finanziamento: Veterans Affairs)
- 24-0284 (Altro identificatore: COMIRB)
- 5I01CX002762-02 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .