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临床试验/NCT03946228
NCT03946228已完成不适用

Reducing Sedentary Behavior to Improve Sleep: an Ancillary Study to the RESET BP Clinical Trial

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2019年5月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
176
试验地点
1
主要终点
Change from baseline actigraphic wake after sleep onset (WASO) at 3 months

研究概览

简要总结

Using a multi-method sleep assessment approach, the purpose of this study is to examine the bidirectional relationship between sleep and sedentary behavior in the context of a randomized trial investigating the impact of sedentary behavior reduction on blood pressure.

详细描述

Disturbed sleep, most notably 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. We also propose that the presence of disturbed sleep during the intervention could blunt the adherence to attempted SED reduction and impact its cardiovascular health benefits. Therefore, the goal of this ancillary study is to test the hypotheses that SED reduction will improve sleep and that the presence of baseline sleep disturbance will reduce the effectiveness of SED reduction efforts. We will test this hypothesis by adding comprehensive sleep assessments to an ongoing randomized clinical trial (NCT03307343) 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.

Anticipating the ability to enroll 150 participants from the remaining sample of the parent trial (estimated N~210), 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]. These data will allow us to efficiently address the following specific aims:

Aim 1: To evaluate the effect of a 3-month SED reduction intervention on objective measures of sleep quality, depth, duration, and OSA severity.

Hypothesis: Participants randomized to the SED reduction intervention will have greater reduction than control participants in actigraphy-assessed WASO (primary outcome [hypothesis 1.1]), PSG-assessed AHI and SWS, and greater increase in actigraphy-assessed TST (secondary outcomes [hypothesis 1.2]).

Aim 2: To examine the effect of baseline disturbed sleep on SED reduction and BP improvement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 21-65 years
  • •SBP of 120-159 mmHg or DBP of 80-99 mmHg
  • •Physically inactive or insufficiently active (i.e., not meeting current aerobic MVPA recommendations [≥150 min/wk])
  • •Currently perform deskwork for ≥ 20 hr/wk at a desk compatible with a sit-stand desk attachment
  • •Employment within 25-mi radius of University of Pittsburgh
  • •Stable employment (≥ 3 mo at current job, plan to be in current job for at least the next 3 mo)
  • •Supervisor approval to join intervention
  • •Possession of cellular phone able to receive text messages

排除标准

  • •SBP ≥ 160 mmHg or DBP ≥ 100 mmHg
  • •Use of anti-hypertensive or glucose-controlling medication
  • •Comorbid condition that would limit ability to reduce sedentary behavior (e.g., musculoskeletal condition)
  • •History of ischemic heart disease, chronic heart failure, stroke, or chronic kidney disease
  • •Inability to obtain consent from primary care provider/physician to participate
  • •Current use of a sit-stand desk or sedentary behavior prompting device
  • •Current enrollment in a weight loss or exercise program, recent (< 1 yr) or planned bariatric surgery
  • •Plans to be away from work for an extended period (>1 wk) during the study period
  • •Current or recent (within last 6 mo) pregnancy; current or recent (within last 3 mo) breastfeeding
  • •Undiagnosed severe OSA (AHI ≥ 30) or insomnia (ISI ≥ 22)

研究组 & 干预措施

Behavioral Intervention

Experimental

The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.

干预措施: Behavioral Intervention (Behavioral)

Control Condition

No Intervention

Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.

结局指标

主要结局

Change from baseline actigraphic wake after sleep onset (WASO) at 3 months

时间窗: 3 months

Primary outcome for Aim 1: actigraphy-assessed wake after sleep onset, averaged over 7 nights

Change from baseline activPAL-assessed sedentary behavior (SED) at 3 months

时间窗: 3 months

Primary outcome for Aim 2: SED, assessed via activPAL inclinometer, averaged over 7 days

Change from baseline resting systolic blood pressure (SBP) at 3 months

时间窗: 3 months

Primary outcome for Aim 2: resting SBP, measured via oscillometric device following a 10-minute rest averaged over two separate occasions

次要结局

  • Change from baseline total sleep time (TST) at 3 months(3 months)
  • Change from baseline 24-hour blood pressure at 3 months(3 months)
  • Change from baseline apnea-hypopnea index (AHI) at 3 months(3 months)
  • Change from baseline slow-wave sleep (SWS) at 3 months(3 months)
  • Change from baseline pulse wave velocity (PWV) at 3 months(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Kline

Assistant Professor

University of Pittsburgh

研究点 (1)

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