Reducing sedentary behavior to improve sleep: an ancillary study to the RESET BP clinical trial
Reducing sedentary behavior to improve sleep: an ancillary study to the RESET BP clinical trial
批准号:
9899321
负责人:
Christopher Edward Kline
金额:
$38.43万
依托单位国家:
美国
项目类别:
财政年份:
2019
资助国家:
美国
项目状态:
已结题
起止时间:
2019-04-01 至 2023-02-28
关键词:
AddressAdherenceAdultAncillary StudyApneaBehaviorBehavior TherapyBehavioralBlood PressureCardiovascular DiseasesCardiovascular systemClinical TrialsDataDevelopmentDimensionsEffectivenessEnergy MetabolismEnrollmentExerciseFundingFutureGoalsGuidelinesHealth BenefitHome environmentHypertensionIndividualInterventionInvestmentsMeasuresMedicineNational Heart, Lung, and Blood InstituteNatureObstructive Sleep ApneaOccupationsParentsParticipantPathway interactionsPatient Self-ReportPolysomnographyPopulationPublic HealthRandomizedRandomized Clinical TrialsRecommendationReportingResearchResearch PersonnelRestRiskRisk FactorsSample SizeSamplingSeveritiesSleepSleep Apnea SyndromesSleep disturbancesSleeplessnessSlow-Wave SleepTestingTimeUnited States National Institutes of HealthUpdateVisionWakefulnessWristactigraphybasecardiovascular healthcardiovascular risk factorexperienceimprovedindexinginsightlight intensitymodifiable riskmultimodalitynovelnovel strategiespost interventionprimary outcomesecondary outcomesedentary lifestyleside effectsleep onsetsleep qualitystandard caretherapeutic evaluationtherapy designtreatment responseworking group
中文摘要
项目摘要/摘要
睡眠障碍,特别是失眠和阻塞性睡眠呼吸暂停(OSA)非常普遍,并与
高血压(BP)和心血管疾病风险增加。不幸的是,尽管
睡眠障碍给公共健康造成了巨大的负担,标准治疗往往受到依从性差的限制,
可获得性不足,和/或严重副作用。因此,确定替代方法以减少
被打扰的睡眠是非常必要的。与增加锻炼相反,我们建议减少
久坐行为(SED),或坐着的时间,是减少睡眠干扰的一种新颖而可行的方法。
来自我们小组的初步证据表明,较大的SED与较差的睡眠质量和
更严重的OSA,我们的试点数据表明,短期减少SED可以改善睡眠连续性(即,
睡眠开始后的觉醒减少[WASO])。鉴于我们小组的工作证明了扰动的影响
睡眠对行为的影响以及睡眠障碍与血压的关系,我们还提出
基线睡眠障碍可能会削弱对尝试减少SED的坚持,并影响其心血管
健康福利。因此,这项辅助研究应用的目标是检验SED减少的假设
会改善睡眠,而睡眠紊乱会降低SED的有效性
通过将全面的睡眠评估添加到正在进行的随机临床试验中来减少工作
观察降低SED对血压的影响。在这项家长试验中,300名血压升高的办公室职员
随机接受为期3个月的多组分行为干预,旨在用以下方法取代每天2-4小时的SED
光照强度活动或3个月无接触控制条件。在父母试验的剩余样本中
(辅助研究开始时估计为N=210),我们将评估基线和干预后的睡眠
使用7个晚上的腕式肌动记录仪和1个晚上的家庭多导睡眠记录仪(PSG),达到了目标
测量睡眠质量(WASO)、总睡眠时间(TST)、OSA严重程度(呼吸暂停低通气指数[AHI]),以及
睡眠深度(慢波睡眠[SWS])。我们将评估SED减少干预的效果
肌动描记评估WASO(主要结果),TST和PSG评估AHI和SWS(目标1)。我们还将
检查基线睡眠障碍对随后SED减少和血压改善的影响(目标2)。
这项辅助研究的结果,有效地利用了正在进行的和运作良好的临床试验,将
对行为睡眠医学建议产生重大影响,因为它将为
减少SED是否是减少睡眠障碍的可行方法。此外,这些发现将告诉我们
持续制定SED指南,并通过以下方式帮助优化未来的SED减少干预措施
评估睡眠障碍是否会影响减少SED的努力。
英文摘要
PROJECT SUMMARY/ABSTRACT
Disturbed sleep, and especially insomnia and obstructive sleep apnea (OSA), is highly prevalent and associated
with increased risk for elevated blood pressure (BP) and cardiovascular disease. Unfortunately, despite the
substantial public health burden of disturbed sleep, standard treatments are often limited by poor adherence,
inadequate availability, and/or significant side effects. As such, identification of alternative approaches to mitigate
disturbed sleep is greatly needed. In contrast to increasing engagement in exercise, we propose that reducing
sedentary behavior (SED), or time spent sitting, is a novel and feasible approach to reduce sleep disturbance.
Preliminary evidence from our group indicates that greater SED is associated with worse sleep quality and
greater OSA severity, and our pilot data suggest that short-term SED reduction improves sleep continuity (i.e.,
reduced wakefulness after sleep onset [WASO]). Given our group's work demonstrating the impact of disturbed
sleep on behavior modification and the relationship between disturbed sleep and BP, we also propose that
disturbed sleep at baseline could blunt the adherence to attempted SED reduction and impact its cardiovascular
health benefits. Therefore, the goal of this ancillary study application is to test the hypotheses that SED reduction
will improve sleep and that the presence of disturbed sleep at baseline will reduce the effectiveness of SED
reduction efforts by adding comprehensive sleep assessments to an ongoing randomized clinical trial that is
examining the effect of SED reduction on BP. In this parent trial, 300 desk workers with elevated BP are
randomized to a 3-month multicomponent behavioral intervention aimed at replacing 2-4 hr/day of SED with
light-intensity activity or a 3-month no-contact control condition. In the remaining sample of the parent trial
(estimated to be N=210 by the start of the ancillary study), we will assess sleep at baseline and post-intervention
using 7 nights of wrist-worn actigraphy and 1 night of home-based polysomnography (PSG), yielding objective
measures of sleep quality (WASO), total sleep time (TST), OSA severity (apnea-hypopnea index [AHI]), and
sleep depth (slow-wave sleep [SWS]). We will evaluate the effect of the SED reduction intervention on
actigraphy-assessed WASO (primary outcome) and TST and PSG-assessed AHI and SWS (Aim 1). We will also
examine the effect of disturbed sleep at baseline on subsequent SED reduction and BP improvement (Aim 2).
Results from this ancillary study, which efficiently leverages an ongoing and well-functioning clinical trial, will
have a significant impact on behavioral sleep medicine recommendations, as it will provide new insight into
whether SED reduction is a viable approach for reducing sleep disturbance. Moreover, these findings will inform
the continuing development of SED guidelines and help optimize future SED reduction interventions by
evaluating whether sleep disturbance impacts SED reduction efforts.
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海外基金