SleepRESET-SLEEPNCT03946228
Reducing Sedentary Behavior to Improve Sleep: an Ancillary Study to the RESET BP Clinical Trial
A study testing Behavioral Intervention in people with Sleep and Obstructive Sleep Apnea, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Sleep, Obstructive Sleep Apnea, Insomnia
- What is being tested?
- Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2019to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-65 years
- SBP of 120-159 mmHg or DBP of 80-99 mmHg
- Physically inactive or insufficiently active (i.e., not meeting current aerobic MVPA recommendations [≥150 min/wk])
- Currently perform deskwork for ≥ 20 hr/wk at a desk compatible with a sit-stand desk attachment
- Employment within 25-mi radius of University of Pittsburgh
- Stable employment (≥ 3 mo at current job, plan to be in current job for at least the next 3 mo)
- Supervisor approval to join intervention
- Possession of cellular phone able to receive text messages
Who cannot join
- SBP ≥ 160 mmHg or DBP ≥ 100 mmHg
- Use of anti-hypertensive or glucose-controlling medication
- Comorbid condition that would limit ability to reduce sedentary behavior (e.g., musculoskeletal condition)
- History of ischemic heart disease, chronic heart failure, stroke, or chronic kidney disease
- Inability to obtain consent from primary care provider/physician to participate
- Current use of a sit-stand desk or sedentary behavior prompting device
Show all 10Show fewer
- Current enrollment in a weight loss or exercise program, recent (< 1 yr) or planned bariatric surgery
- Plans to be away from work for an extended period (>1 wk) during the study period
- Current or recent (within last 6 mo) pregnancy; current or recent (within last 3 mo) breastfeeding
- Undiagnosed severe OSA (AHI ≥ 30) or insomnia (ISI ≥ 22)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Physical Activity and Weight Management Research Center
Pittsburgh, Pennsylvania, 15261
About this study
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.
Read the 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.
- Conditions
- Sleep, Obstructive Sleep Apnea, Insomnia
- Being tested
- Behavioral Intervention
- Keywords
- blood pressure, sedentary behavior, physical activity
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Behavioral Intervention | Experimental | 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. Receives: Behavioral: Behavioral Intervention |
| Control Condition | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 months
Secondary outcomes (5)
Change from baseline total sleep time (TST) at 3 months
Secondary outcome for Aim 1: actigraphy-assessed TST, averaged over 7 nights
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start6 May 2019
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Christopher Kline, University of Pittsburgh
- Investigators
- Christopher E Kline, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946228
- Sponsor's protocol ID
- STUDY18120122
- Other IDs
- R01HL147610
- Acronym
- RESET-SLEEP
- Status last verified
- Jul 2023
- First submitted
- 8 May 2019
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sedentary Behavior to Improve Sleep: an Ancillary Study to the RESET BP Clinical Trial
- ClinicalTrials.gov ID
- NCT03946228
- Acronym / sponsor ID
- RESET-SLEEP / STUDY18120122
- Conditions
- Sleep, Obstructive Sleep Apnea, Insomnia
- Keywords
- blood pressure, sedentary behavior, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 6 May 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention | Experimental | Behavioral: Behavioral InterventionThe 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. |
| Control Condition | No 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 21-65 years
- SBP of 120-159 mmHg or DBP of 80-99 mmHg
- Physically inactive or insufficiently active (i.e., not meeting current aerobic MVPA recommendations [≥150 min/wk])
- Currently perform deskwork for ≥ 20 hr/wk at a desk compatible with a sit-stand desk attachment
- Employment within 25-mi radius of University of Pittsburgh
Key exclusion criteria (10 listed)
- SBP ≥ 160 mmHg or DBP ≥ 100 mmHg
- Use of anti-hypertensive or glucose-controlling medication
- Comorbid condition that would limit ability to reduce sedentary behavior (e.g., musculoskeletal condition)
- History of ischemic heart disease, chronic heart failure, stroke, or chronic kidney disease
- Inability to obtain consent from primary care provider/physician to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral InterventionThe 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. | Behavioural | Behavioral Intervention |
Primary outcome
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
5 secondary outcomes
Change from baseline total sleep time (TST) at 3 months
Time frame: 3 months
Change from baseline apnea-hypopnea index (AHI) at 3 months
Time frame: 3 months
Change from baseline slow-wave sleep (SWS) at 3 months
Time frame: 3 months
Change from baseline 24-hour blood pressure at 3 months
Time frame: 3 months
Change from baseline pulse wave velocity (PWV) at 3 months
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher E Kline, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention in people with Sleep and Obstructive Sleep Apnea, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline actigraphic wake after sleep onset (WASO) at 3 months (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.