NCT02202811|Completed
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Sponsor study identifier
interventional
39
1 country
1
Study Start
August 2014
Actual (reported)Primary Completion
March 9, 2020
Actual (reported)Study Completion
March 9, 2020
Actual (reported)The purpose of this study is to understand how behaviors and the effects of the body's internal clock (called the circadian pacemaker) affect the control of the heart and blood pressure. People with Obstructive Sleep Apnea (OSA) are hypothesized to have altered circadian amplitudes in certain key indices of cardiovascular (CV) and an abnormally advanced circadian phase in some of the same key indices of CV risk. The investigators hypothesize that such changes, taken together, may explain the different timing of heart attack and sudden cardiac death in OSA.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 9, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 17, 2014
Actual (reported)July 29, 2014
Actual (reported)August 2014
Actual (reported)March 9, 2020
Actual (reported)March 9, 2020
Actual (reported)Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma epinephrine concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm phase of plasma epinephrine concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma epinephrine concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Over 5 days
Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma epinephrine concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP)
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of systolic and diastolic BP during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm phase of blood pressure (BP)
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of systolic and diastolic BP during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Over 5 days
Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in systolic and diastolic BP from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm amplitude of plasma cortisol concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma cortisol concentration during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm phase of plasma cortisol concentration
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma cortisol concentration during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Over 5 days
Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma cortisol concentration from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm amplitude of heart rate
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of heart rate during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm phase of heart rate
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of heart rate during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Over 5 days
Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm phase of heart rate reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm phase of heart rate reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in heart rate from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of cardiac vagal tone during resting baseline conditions. Circadian rhythm amplitude will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm phase of cardiac vagal tone
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of cardiac vagal tone during resting baseline conditions. Circadian rhythm phase will be assessed by cosinor analysis of all resting measurements obtained throughout the protocol assessed under constant conditions but at varied circadian phases and stated in relation to the reported habitual sleep time.
Over 5 days
Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting baseline to end of 15 minutes of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to exercise
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting baseline to end of 15 minute of steady-state bicycle exercise. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by exercise obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to change in posture
Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in cardiac vagal tone from resting supine to end of 5 minutes of standing. Circadian rhythm amplitude of reactivity will be assessed by cosinor analysis of all changes induced by change in posture obtained throughout the protocol assessed under constant conditions but at varied circadian phases.
Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma tissue plasminogen activator inhibitor (tPA) concentration
Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma tPA concentration
Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to exercise
Over 5 days
Secondary dependent variable: Circadian rhythm phase of plasma tPA reactivity to exercise
Over 5 days
Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to change in posture
Over 5 days
Forced Desynchrony, OSA
Forced Desynchrony, Control
all sleep opportunities and other activities will be scheduled by the experimenter so that by the end of the study these activities are spread evenly across all phases of the internal body clock.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Oregon Health & Science University
Portland, Oregon, 97239, United States
Thosar SS, Bowles NP, Butler MP, McHill AW, Rice SPM, Emens JS, Shea SA. Endogenous Circadian System Attenuates Nighttime Vascular Endothelial Function in People With Untreated Obstructive Sleep Apnea. J Am Heart Assoc. 2025 Nov 18;14(22):e043596. doi: 10.1161/JAHA.125.043596. Epub 2025 Nov 6.
Thosar SS, Berman AM, Herzig MX, McHill AW, Bowles NP, Swanson CM, Clemons NA, Butler MP, Clemons AA, Emens JS, Shea SA. Circadian Rhythm of Vascular Function in Midlife Adults. Arterioscler Thromb Vasc Biol. 2019 Jun;39(6):1203-1211. doi: 10.1161/ATVBAHA.119.312682.
Steven A Shea, PhD
Oregon Health and Science University
39 participants (actual enrollment reported by the registry).
First Submitted
July 17, 2014
First Posted
July 29, 2014
Study Start
August 2014
Actual (reported)Sleep Apnea Video Education for CPAP (SAVE-CPAP)
Primary Completion
March 9, 2020
Actual (reported)Study Completion
March 9, 2020
Actual (reported)Last Updated
July 2, 2025
Record last verified: 2025-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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