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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.
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. Hypothesis: Intervention-induced reductions in SED (hypothesis 2.1) and BP (hypothesis 2.2) will be smaller among individuals with disturbed sleep (e.g., elevated WASO or AHI) at baseline.
Age
21 - 65 years
Sex
ALL
Healthy Volunteers
No
University of Pittsburgh Physical Activity and Weight Management Research Center
Pittsburgh, Pennsylvania, United States
Start Date
May 6, 2019
Primary Completion Date
December 30, 2022
Completion Date
December 30, 2022
Last Updated
July 7, 2023
176
ACTUAL participants
Behavioral Intervention
BEHAVIORAL
Lead Sponsor
University of Pittsburgh
Collaborators
NCT06430957
NCT01778504
Data Source & Attribution
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