NightWare Therapeutic Platform for improving Cardiovascular Health inAdults With Nightmares Associated with PTSD
NightWare 治疗平台可改善患有 PTSD 相关噩梦的成年人的心血管健康
基本信息
- 批准号:10559634
- 负责人:
- 金额:$ 19.44万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-02-01 至 2025-01-31
- 项目状态:未结题
- 来源:
- 关键词:3-nitrotyrosineAccelerationAddressAdherenceAdultAgeAgingAmendmentApple watchAutonomic DysfunctionBaroreflexBiological AvailabilityBiological MarkersBiometryBlood VesselsBreakthrough deviceCardiovascular DiseasesCardiovascular PhysiologyCarotid ArteriesCharacteristicsClinicalClinical TrialsComplexDataDevelopmentDisabled PersonsDistressDouble-Blind MethodDrowsinessDrug Metabolic DetoxicationElasticityEndothelial CellsEndotheliumFatigueFeedbackFemurFree RadicalsFutureGoalsGrantHeart RateImageryImpaired cognitionImpairmentIndividualInflammationInterruptionInterventionInvestigationKnowledgeLearningLifeLinkMachine LearningMeasuresMediatingMethodsModelingMovementNightmareNitric OxideNuclearOccupationalOutcomeOxidative StressPersonsPharmacologic SubstancePhysiologic pulsePhysiologicalPilot ProjectsPittsburgh Sleep Quality IndexPlacebosPost-Traumatic Stress DisordersPrazosinProblem behaviorProductionPsychotherapyRandomizedRiskRisk ReductionSleepSleep DeprivationSleep disturbancesSleeplessnessStressSuperoxidesSymptomsSystemTherapeuticTherapeutic InterventionTimeVascular DiseasesVenousWomanWristactigraphyaffective disturbancearterial stiffnessbrachial arterycardiovascular disorder riskcardiovascular healthcardiovascular risk factorclinically significantdigital medicinedigital platformdigital treatmentdisabling symptomearly onseteffectiveness evaluationendothelial dysfunctionheart rate variabilityimplementation barriersimprovedimproved outcomeimprovement on sleepindexinginsightmennovelperipheral bloodpharmacologicpost-traumatic symptomsprematurerandomized, clinical trialsrehearsalresponsesleep onsetsleep patternsleep qualitysmart watchsocialstress related disordersuicidal risktherapeutically effectivetissue repairultrasoundvascular endothelial dysfunctionvibration
项目摘要
PROJECT SUMMARY/ABSTRACT
Post traumatic stress disorder (PTSD) is linked to accelerated aging and is associated with increased risk of
early-onset cardiovascular disease (CVD) in both men and women. PTSD is associated with premature
vascular aging (i.e., large elastic arterial stiffening and vascular endothelial dysfunction) and autonomic
dysfunction (e.g., reduced cardiovagal baroreflex sensitivity [cBRS] and heart rate variability [HRV]), key
antecedents in the development of CVD. Sleep is important for cardiovascular health via cellular and tissue
repair, free radical detoxification and reducing oxidative stress and inflammation. Nightmares, a central feature
of PTSD, are a debilitating condition that can lead to sleep deprivation or insomnia, daytime sleepiness and
other sequala, that ultimately causes clinically significant distress and impairment in social, occupational and
cardiovascular function. As such, therapeutic strategies and interventions that address nightmare-associated
sleep disturbances in individuals with PTSD is clinically important for improving sleep quality, cardiovascular
health and risk for future age-associated CVD. NightWare™ digital therapeutic system 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 machine learning to detect, track and arouse an individual out of a
nightmare by sending vibrotactile feedback to a smart watch, and arousing the individual out of the nightmare
without awakening and disrupting sleep. In the present R21 we are proposing a randomized, double-blind,
placebo (i.e., sham intervention) controlled parallel pilot study that will provide the first clinical evidence for the
efficacy of the NightWare digital therapeutic system to improve cardiovascular health outcomes in adults with
nightmares associated with PTSD. An additional goal of this R21 will be to obtain exploratory mechanistic
insight by which NightWare improves cardiovascular function, specifically, related to sleep quality, nitric oxide
bioavailability, free radical production, oxidative stress and inflammation. We hypothesize that 6 weeks of the
NightWare intervention will improve outcomes of vascular aging (e.g., large elastic arterial stiffening, vascular
endothelial dysfunction) and autonomic function (cBRS, HRV) in adults with PTSD-related nightmares. The
results from this pilot investigation will provide the basis for a larger randomized clinical trial that would be
conducted to establish the efficacy of NightWare as a safe and effective therapeutic strategy for treating
nightmares, promoting healthy vascular aging, autonomic function and reducing the risk for CVD later in life in
adults with nightmares associated with PTSD.
项目总结/文摘
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Kerrie Moreau其他文献
Kerrie Moreau的其他文献
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{{ truncateString('Kerrie Moreau', 18)}}的其他基金
MitoQ supplementation for restoring aerobic exercise training effects on endothelial function in postmenopausal women
补充 MitoQ 恢复有氧运动训练对绝经后女性内皮功能的影响
- 批准号:
10686453 - 财政年份:2022
- 资助金额:
$ 19.44万 - 项目类别:
NightWare Therapeutic Platform for improving Cardiovascular Health inAdults With Nightmares Associated with PTSD
NightWare 治疗平台可改善患有 PTSD 相关噩梦的成年人的心血管健康
- 批准号:
10351054 - 财政年份:2022
- 资助金额:
$ 19.44万 - 项目类别:
Cardiovascular Consequences of Hypogonadism in Men
男性性腺功能减退症的心血管后果
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9206973 - 财政年份:2016
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Biological Mechanisms of Vascular Dysfunction with Age and Estrogen Deficiency
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8732808 - 财政年份:2013
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卵巢功能丧失的心脏代谢后果
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10712609 - 财政年份:2012
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$ 19.44万 - 项目类别:
BIOLOGICAL MECHANISMS OF ARTERIAL STIFFENING WITH AGE AND ESTROGEN
年龄和雌激素导致动脉硬化的生物学机制
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7719538 - 财政年份:2008
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SEX HORMONE REGULATION OF LARGE ARTERY STIFFNESS IN MEN
性激素对男性大动脉僵硬的调节
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7719481 - 财政年份:2008
- 资助金额:
$ 19.44万 - 项目类别:
HRT AND EXERCISE EFFECTS ON CENTRAL ARTERIAL COMPLIANCE
激素替代疗法和运动对中央动脉顺应性的影响
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7719504 - 财政年份:2008
- 资助金额:
$ 19.44万 - 项目类别:
HRT AND EXERCISE EFFECTS ON CENTRAL ARTERIAL COMPLIANCE
激素替代疗法和运动对中央动脉顺应性的影响
- 批准号:
7719544 - 财政年份:2008
- 资助金额:
$ 19.44万 - 项目类别:
HRT AND EXERCISE EFFECTS ON CENTRAL ARTERIAL COMPLIANCE
激素替代疗法和运动对中央动脉顺应性的影响
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7604454 - 财政年份:2007
- 资助金额:
$ 19.44万 - 项目类别:
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