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

Obstructive Sleep Apnea Clinical Trial

— RESET-SLEEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03946228
• Other study ID #: STUDY18120122
• Secondary ID: R01HL147610
• Status: Completed
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Insomnia
• Obstructive Sleep Apnea
• Sleep
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Physical Activity and Weight Management Research Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline self-reported sleep patterns at 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	3 months
Other	Change from baseline Epworth Sleepiness Scale (ESS) scores at 3 months	The ESS, a measure of daytime sleepiness, will be administered at baseline and 3 months; total score will be used	3 months
Other	Change from baseline Insomnia Severity Index (ISI) scores at 3 months	The ISI, a measure of insomnia symptom severity, will be administered at baseline and 3 months; total score will be used	3 months
Other	Change from baseline Functional Outcomes of Sleep Questionnaire (FOSQ) scores at 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	3 months
Other	Change from baseline PROMIS Sleep-related Impairment scale scores at 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	3 months
Other	Change from baseline Pittsburgh Sleep Quality Index (PSQI) scores at 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	3 months
Other	Change from baseline actigraphic sleep patterns at 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	3 months
Other	Change from baseline polysomnography (PSG)-assessed sleep patterns at 3 months	Polysomnography will be performed in the participant's home at baseline and 3 months	3 months
Other	Change from baseline weight at 3 months	Weight will be measured by digital scale at baseline and 3 months	3 months
Other	Change from baseline glucose at 3 months	Glucose will be measured from a fasting blood draw at baseline and 3 months	3 months
Other	Change from baseline insulin at 3 months	Insulin will be measured from a fasting blood draw at baseline and 3 months	3 months
Other	Change from baseline accelerometer-assessed physical activity at 3 months	Physical activity will be assessed via waist-worn ActiGraph GT3X accelerometer at baseline and 3 months	3 months
Primary	Change from baseline actigraphic wake after sleep onset (WASO) at 3 months	Primary outcome for Aim 1: actigraphy-assessed wake after sleep onset, averaged over 7 nights	3 months
Primary	Change from baseline activPAL-assessed sedentary behavior (SED) at 3 months	Primary outcome for Aim 2: SED, assessed via activPAL inclinometer, averaged over 7 days	3 months
Primary	Change from baseline resting systolic blood pressure (SBP) at 3 months	Primary outcome for Aim 2: resting SBP, measured via oscillometric device following a 10-minute rest averaged over two separate occasions	3 months
Secondary	Change from baseline total sleep time (TST) at 3 months	Secondary outcome for Aim 1: actigraphy-assessed TST, averaged over 7 nights	3 months
Secondary	Change from baseline apnea-hypopnea index (AHI) at 3 months	Secondary outcome for Aim 1: polysomnography-assessed AHI, assessed over 1 night of home-based recording	3 months
Secondary	Change from baseline slow-wave sleep (SWS) at 3 months	Secondary outcome for Aim 1: polysomnography-assessed slow-wave sleep, assessed over 1 night of home-based recording	3 months
Secondary	Change from baseline 24-hour blood pressure at 3 months	Secondary outcome for Aim 2: blood pressure, assessed by an ambulatory monitor during a workday and overnight for 24 hours total	3 months
Secondary	Change from baseline pulse wave velocity (PWV) at 3 months	Secondary outcome for Aim 2: carotid-femoral and carotid-radial PWV, assessed via tonometry following a 10-minute rest	3 months