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出境医 / 临床实验 / Reducing Sedentary Behavior to Improve Sleep: an Ancillary Study to the RESET BP Clinical Trial (RESET-SLEEP)

Reducing Sedentary Behavior to Improve Sleep: an Ancillary Study to the RESET BP Clinical Trial (RESET-SLEEP)

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Obstructive Sleep Apnea Insomnia Behavioral: Behavioral Intervention Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Sedentary Behavior to Improve Sleep: an Ancillary Study to the RESET BP Clinical Trial
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Behavioral Intervention
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.
Behavioral: Behavioral Intervention
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.

No Intervention: Control Condition
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.
Outcome Measures
Primary Outcome Measures :
  1. Change from baseline actigraphic wake after sleep onset (WASO) at 3 months [ Time Frame: 3 months ]
    Primary outcome for Aim 1: actigraphy-assessed wake after sleep onset, averaged over 7 nights

  2. Change from baseline activPAL-assessed sedentary behavior (SED) at 3 months [ Time Frame: 3 months ]
    Primary outcome for Aim 2: SED, assessed via activPAL inclinometer, averaged over 7 days

  3. Change from baseline resting systolic blood pressure (SBP) at 3 months [ Time Frame: 3 months ]
    Primary outcome for Aim 2: resting SBP, measured via oscillometric device following a 10-minute rest averaged over two separate occasions


Secondary Outcome Measures :
  1. Change from baseline total sleep time (TST) at 3 months [ Time Frame: 3 months ]
    Secondary outcome for Aim 1: actigraphy-assessed TST, averaged over 7 nights

  2. Change from baseline apnea-hypopnea index (AHI) at 3 months [ Time Frame: 3 months ]
    Secondary outcome for Aim 1: polysomnography-assessed AHI, assessed over 1 night of home-based recording

  3. Change from baseline slow-wave sleep (SWS) at 3 months [ Time Frame: 3 months ]
    Secondary outcome for Aim 1: polysomnography-assessed slow-wave sleep, assessed over 1 night of home-based recording

  4. Change from baseline 24-hour blood pressure at 3 months [ Time Frame: 3 months ]
    Secondary outcome for Aim 2: blood pressure, assessed by an ambulatory monitor during a workday and overnight for 24 hours total

  5. Change from baseline pulse wave velocity (PWV) at 3 months [ Time Frame: 3 months ]
    Secondary outcome for Aim 2: carotid-femoral and carotid-radial PWV, assessed via tonometry following a 10-minute rest


Other Outcome Measures:
  1. Change from baseline self-reported sleep patterns at 3 months [ Time Frame: 3 months ]
    Self-reported sleep patterns will be assessed via a daily diary; mean and measures of variability will be obtained from 7 nights of data

  2. Change from baseline Epworth Sleepiness Scale (ESS) scores at 3 months [ Time Frame: 3 months ]
    The ESS, a measure of daytime sleepiness, will be administered at baseline and 3 months; total score will be used

  3. Change from baseline Insomnia Severity Index (ISI) scores at 3 months [ Time Frame: 3 months ]
    The ISI, a measure of insomnia symptom severity, will be administered at baseline and 3 months; total score will be used

  4. Change from baseline Functional Outcomes of Sleep Questionnaire (FOSQ) scores at 3 months [ Time Frame: 3 months ]
    The 10-item version of the FOSQ, a measure of daytime dysfunction due to poor sleep, will be administered at baseline and 3 months; total score will be used

  5. Change from baseline PROMIS Sleep-related Impairment scale scores at 3 months [ Time Frame: 3 months ]
    The PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep-related Impairment Scale, a measure of daytime impairment, will be administered at baseline and 3 months; total score will be used

  6. Change from baseline Pittsburgh Sleep Quality Index (PSQI) scores at 3 months [ Time Frame: 3 months ]
    PSQI will be administered at baseline and 3 months; global score and 3 factors (sleep efficiency, perceived sleep quality, daily disturbances) will be used

  7. Change from baseline actigraphic sleep patterns at 3 months [ Time Frame: 3 months ]
    Actigraphic sleep patterns will be assessed with the Actiwatch Spectrum Plus; mean and measures of variability will be obtained from 7 nights of data

  8. Change from baseline polysomnography (PSG)-assessed sleep patterns at 3 months [ Time Frame: 3 months ]
    Polysomnography will be performed in the participant's home at baseline and 3 months

  9. Change from baseline weight at 3 months [ Time Frame: 3 months ]
    Weight will be measured by digital scale at baseline and 3 months

  10. Change from baseline glucose at 3 months [ Time Frame: 3 months ]
    Glucose will be measured from a fasting blood draw at baseline and 3 months

  11. Change from baseline insulin at 3 months [ Time Frame: 3 months ]
    Insulin will be measured from a fasting blood draw at baseline and 3 months

  12. Change from baseline accelerometer-assessed physical activity at 3 months [ Time Frame: 3 months ]
    Physical activity will be assessed via waist-worn ActiGraph GT3X accelerometer at baseline and 3 months


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Locations
Layout table for location information
United States, Pennsylvania
University of Pittsburgh Physical Activity and Weight Management Research Center
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Christopher E Kline, PhD Assistant Professor
Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE May 6, 2019
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Change from baseline actigraphic wake after sleep onset (WASO) at 3 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months ]
    Primary outcome for Aim 2: resting SBP, measured via oscillometric device following a 10-minute rest averaged over two separate occasions
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Change from baseline total sleep time (TST) at 3 months [ Time Frame: 3 months ]
    Secondary outcome for Aim 1: actigraphy-assessed TST, averaged over 7 nights
  • Change from baseline apnea-hypopnea index (AHI) at 3 months [ Time Frame: 3 months ]
    Secondary outcome for Aim 1: polysomnography-assessed AHI, assessed over 1 night of home-based recording
  • Change from baseline slow-wave sleep (SWS) at 3 months [ Time Frame: 3 months ]
    Secondary outcome for Aim 1: polysomnography-assessed slow-wave sleep, assessed over 1 night of home-based recording
  • Change from baseline 24-hour blood pressure at 3 months [ Time Frame: 3 months ]
    Secondary outcome for Aim 2: blood pressure, assessed by an ambulatory monitor during a workday and overnight for 24 hours total
  • Change from baseline pulse wave velocity (PWV) at 3 months [ Time Frame: 3 months ]
    Secondary outcome for Aim 2: carotid-femoral and carotid-radial PWV, assessed via tonometry following a 10-minute rest
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 9, 2019)
  • Change from baseline self-reported sleep patterns at 3 months [ Time Frame: 3 months ]
    Self-reported sleep patterns will be assessed via a daily diary; mean and measures of variability will be obtained from 7 nights of data
  • Change from baseline Epworth Sleepiness Scale (ESS) scores at 3 months [ Time Frame: 3 months ]
    The ESS, a measure of daytime sleepiness, will be administered at baseline and 3 months; total score will be used
  • Change from baseline Insomnia Severity Index (ISI) scores at 3 months [ Time Frame: 3 months ]
    The ISI, a measure of insomnia symptom severity, will be administered at baseline and 3 months; total score will be used
  • Change from baseline Functional Outcomes of Sleep Questionnaire (FOSQ) scores at 3 months [ Time Frame: 3 months ]
    The 10-item version of the FOSQ, a measure of daytime dysfunction due to poor sleep, will be administered at baseline and 3 months; total score will be used
  • Change from baseline PROMIS Sleep-related Impairment scale scores at 3 months [ Time Frame: 3 months ]
    The PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep-related Impairment Scale, a measure of daytime impairment, will be administered at baseline and 3 months; total score will be used
  • Change from baseline Pittsburgh Sleep Quality Index (PSQI) scores at 3 months [ Time Frame: 3 months ]
    PSQI will be administered at baseline and 3 months; global score and 3 factors (sleep efficiency, perceived sleep quality, daily disturbances) will be used
  • Change from baseline actigraphic sleep patterns at 3 months [ Time Frame: 3 months ]
    Actigraphic sleep patterns will be assessed with the Actiwatch Spectrum Plus; mean and measures of variability will be obtained from 7 nights of data
  • Change from baseline polysomnography (PSG)-assessed sleep patterns at 3 months [ Time Frame: 3 months ]
    Polysomnography will be performed in the participant's home at baseline and 3 months
  • Change from baseline weight at 3 months [ Time Frame: 3 months ]
    Weight will be measured by digital scale at baseline and 3 months
  • Change from baseline glucose at 3 months [ Time Frame: 3 months ]
    Glucose will be measured from a fasting blood draw at baseline and 3 months
  • Change from baseline insulin at 3 months [ Time Frame: 3 months ]
    Insulin will be measured from a fasting blood draw at baseline and 3 months
  • Change from baseline accelerometer-assessed physical activity at 3 months [ Time Frame: 3 months ]
    Physical activity will be assessed via waist-worn ActiGraph GT3X accelerometer at baseline and 3 months
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Reducing Sedentary Behavior to Improve Sleep: an Ancillary Study to the RESET BP Clinical Trial
Official Title  ICMJE Reducing Sedentary Behavior to Improve Sleep: an Ancillary Study to the RESET BP Clinical Trial
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep
  • Obstructive Sleep Apnea
  • Insomnia
Intervention  ICMJE Behavioral: Behavioral Intervention
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.
Study Arms  ICMJE
  • Experimental: Behavioral Intervention
    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.
    Intervention: Behavioral: Behavioral Intervention
  • No Intervention: Control Condition
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. SBP ≥ 160 mmHg or DBP ≥ 100 mmHg
  2. Use of anti-hypertensive or glucose-controlling medication
  3. Comorbid condition that would limit ability to reduce sedentary behavior (e.g., musculoskeletal condition)
  4. History of ischemic heart disease, chronic heart failure, stroke, or chronic kidney disease
  5. Inability to obtain consent from primary care provider/physician to participate
  6. Current use of a sit-stand desk or sedentary behavior prompting device
  7. Current enrollment in a weight loss or exercise program, recent (< 1 yr) or planned bariatric surgery
  8. Plans to be away from work for an extended period (>1 wk) during the study period
  9. Current or recent (within last 6 mo) pregnancy; current or recent (within last 3 mo) breastfeeding
  10. Undiagnosed severe OSA (AHI ≥ 30) or insomnia (ISI ≥ 22)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03946228
Other Study ID Numbers  ICMJE STUDY18120122
R01HL147610 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual deidentified data that are relevant to the primary aims of the study will be provided to external investigators along with a relevant data dictionary.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Beginning 1 year following peer-reviewed publication of research questions outlined in grant and ending 5 years following publication of study results
Access Criteria: Data access will be provided to external researchers who provide a methodologically sound proposal for secondary data analysis that is approved by the investigators of the study. Proposals should be directed to the study PI.
Responsible Party Christopher Kline, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Christopher E Kline, PhD Assistant Professor
PRS Account University of Pittsburgh
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP