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PTSD 퇴역군인의 NightWare 및 심혈관 건강

2026년 10월 6일 업데이트: VA Office of Research and Development

NightWare로 외상 관련 악몽을 치료하여 PTSD를 앓고 있는 퇴역 군인의 심혈관 건강 개선

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

125

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Colorado
      • Aurora, Colorado, 미국, 80045-7211
        • 모병
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
        • 수석 연구원:
          • Kerrie L Moreau, PhD
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

22년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. 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)
  2. Self-report having repetitive nightmares contributing to disrupted sleep
  3. Resting blood pressure (BP, <160/100 millimeters of mercury (mmHg)
  4. Fasted glucose <126 milligrams per deciliter (mg/dL)
  5. Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher
  6. 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
  7. Wireless Internet and two power outlets in sleeping location
  8. 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 Cardiovascular disease (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 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
  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 NightWare (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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

가짜 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Pittsburgh Sleep Quality Index
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in physiological sleep - total sleep time
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Kerrie L Moreau, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 9월 10일

기본 완료 (추정된)

2027년 9월 30일

연구 완료 (추정된)

2027년 12월 31일

연구 등록 날짜

최초 제출

2024년 5월 3일

QC 기준을 충족하는 최초 제출

2024년 5월 14일

처음 게시됨 (실제)

2024년 5월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 6일

마지막으로 확인됨

2026년 10월 1일

추가 정보

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아니요

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아니

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예

미국에서 제조되어 미국에서 수출되는 제품

예

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