Reducing Sedentary Behavior to Improve Sleep: an Ancillary Study to the RESET BP Clinical Trial
Condition: Sleep; Obstructive Sleep Apnea; Insomnia
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Behavioral Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention will be delivered by trained research staff who are exercise physiologists or behavioral lifestyle counselors. This target reflects a recent expert statement concluding that desk-based workers should reduce workday sedentary behavior by 2-4 hr (by increasing standing and movement). The approach will combine: 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. The initial in-person session will occur at the participant's office location. During months 2 and 3, one-on-one in-person meetings will occur at the research lab. Telephone intervention contacts will occur in the 3rd week of months 1-3.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: blood pressure; sedentary behavior; physical activity