An interventional study of Behavioral Intervention in Sleep, Obstructive Sleep Apnea and Insomnia, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-07.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 176 is above the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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.
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
Change from baseline total sleep time (TST) at 3 months
Secondary outcome for Aim 1: actigraphy-assessed TST, averaged over 7 nights
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
Change from baseline weight at 3 months
Weight will be measured by digital scale at baseline and 3 months
Time frame: 3 months
Change from baseline glucose at 3 months
Glucose will be measured from a fasting blood draw at baseline and 3 months
Time frame: 3 months
Change from baseline insulin at 3 months
Insulin will be measured from a fasting blood draw at baseline and 3 months
Time frame: 3 months
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
Time frame: 3 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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 information: Study protocol, Statistical analysis plan, Informed consent form
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.
Ran from May 2019 to primary completion in Dec 2022, 43 months.
Of 511 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's 43 months is above that.
Counting every sponsor, half of 621 studies reached it within 26 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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