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Circadian Rhythms and Cardiovascular Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202811
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Steven A. Shea, Oregon Health and Science University

Brief Summary:

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.


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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Circadian Rhythms and Cardiovascular Risk
Actual Study Start Date : August 2014
Actual Primary Completion Date : March 9, 2020
Actual Study Completion Date : March 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Obstructive Sleep Apnea
Forced Desynchrony, OSA
Behavioral: Forced Desynchrony
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.

Placebo Comparator: Control
Forced Desynchrony, Control
Behavioral: Forced Desynchrony
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.




Primary Outcome Measures :
  1. Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine concentration [ Time Frame: Over 5 days ]
    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.

  2. Primary dependent variable: Circadian rhythm phase of plasma epinephrine concentration [ Time Frame: Over 5 days ]
    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.

  3. Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to exercise [ Time Frame: Over 5 days ]
    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.

  4. Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to exercise [ Time Frame: Over 5 days ]
    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.

  5. Primary dependent variable: Circadian rhythm amplitude of plasma epinephrine reactivity to change in posture [ Time Frame: Over 5 days ]
    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.

  6. Primary dependent variable: Circadian rhythm phase of plasma epinephrine reactivity to change in posture [ Time Frame: Over 5 days ]
    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.

  7. Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) [ Time Frame: Over 5 days ]
    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.

  8. Primary dependent variable: Circadian rhythm phase of blood pressure (BP) [ Time Frame: Over 5 days ]
    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.

  9. Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to exercise [ Time Frame: Over 5 days ]
    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.

  10. Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to exercise [ Time Frame: Over 5 days ]
    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.

  11. Primary dependent variable: Circadian rhythm amplitude of blood pressure (BP) reactivity to change in posture [ Time Frame: Over 5 days ]
    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.

  12. Primary dependent variable: Circadian rhythm phase of blood pressure (BP) reactivity to change in posture [ Time Frame: Over 5 days ]
    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.

  13. Primary dependent variable: Circadian rhythm amplitude of plasma cortisol concentration [ Time Frame: Over 5 days ]
    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.

  14. Primary dependent variable: Circadian rhythm phase of plasma cortisol concentration [ Time Frame: Over 5 days ]
    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.

  15. Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to exercise [ Time Frame: Over 5 days ]
    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.

  16. Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to exercise [ Time Frame: Over 5 days ]
    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.

  17. Primary dependent variable: Circadian rhythm amplitude of plasma cortisol reactivity to change in posture [ Time Frame: Over 5 days ]
    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.

  18. Primary dependent variable: Circadian rhythm phase of plasma cortisol reactivity to change in posture [ Time Frame: Over 5 days ]
    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.

  19. Primary dependent variable: Circadian rhythm amplitude of heart rate [ Time Frame: Over 5 days ]
    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.

  20. Primary dependent variable: Circadian rhythm phase of heart rate [ Time Frame: Over 5 days ]
    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.

  21. Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to exercise [ Time Frame: Over 5 days ]
    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.

  22. Primary dependent variable: Circadian rhythm phase of heart rate reactivity to exercise [ Time Frame: Over 5 days ]
    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.

  23. Primary dependent variable: Circadian rhythm amplitude of heart rate reactivity to change in posture [ Time Frame: Over 5 days ]
    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.

  24. Primary dependent variable: Circadian rhythm phase of heart rate reactivity to change in posture [ Time Frame: Over 5 days ]
    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.

  25. Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone [ Time Frame: Over 5 days ]
    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.

  26. Primary dependent variable: Circadian rhythm phase of cardiac vagal tone [ Time Frame: Over 5 days ]
    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.

  27. Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to exercise [ Time Frame: Over 5 days ]
    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.

  28. Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to exercise [ Time Frame: Over 5 days ]
    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.

  29. Primary dependent variable: Circadian rhythm amplitude of cardiac vagal tone reactivity to change in posture [ Time Frame: Over 5 days ]
    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.

  30. Primary dependent variable: Circadian rhythm phase of cardiac vagal tone reactivity to change in posture [ Time Frame: Over 5 days ]
    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.


Secondary Outcome Measures :
  1. Secondary dependent variable: Circadian rhythm amplitude of plasma tissue plasminogen activator inhibitor (tPA) concentration [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma tPA 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.

  2. Secondary dependent variable: Circadian rhythm phase of plasma tPA concentration [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma tPA 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.

  3. Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to exercise [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA 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.

  4. Secondary dependent variable: Circadian rhythm phase of plasma tPA reactivity to exercise [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA 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.

  5. Secondary dependent variable: Circadian rhythm amplitude of plasma tPA reactivity to change in posture [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA 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.

  6. Secondary dependent variable: Circadian rhythm phase of plasma tPA reactivity to change in posture [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma tPA 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.

  7. Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of vascular endothelial function 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.

  8. Secondary dependent variable: Circadian rhythm phase of vascular endothelial function [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of vascular endothelial function 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.

  9. Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function reactivity to exercise [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function 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.

  10. Secondary dependent variable: Circadian rhythm phase of vascular endothelial function reactivity to exercise [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function 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.

  11. Secondary dependent variable: Circadian rhythm amplitude of vascular endothelial function reactivity to change in posture [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function 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.

  12. Secondary dependent variable: Circadian rhythm phase of vascular endothelial function reactivity to change in posture [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in vascular endothelial function 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.

  13. Secondary dependent variable: Circadian rhythm amplitude of plasma plasminogen activator inhibitor 1 (PAI-1) concentration [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma PAI-1 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.

  14. Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 concentration [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma PAI-1 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.

  15. Secondary dependent variable: Circadian rhythm amplitude of plasma PAI-1 reactivity to exercise [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 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.

  16. Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 concentration reactivity to exercise [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 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.

  17. Secondary dependent variable: Circadian rhythm amplitude of plasma PAI-1 reactivity to change in posture [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 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.

  18. Secondary dependent variable: Circadian rhythm phase of plasma PAI-1 reactivity to change in posture [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma PAI-1 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.

  19. Secondary dependent variable: Circadian rhythm amplitude of plasma MDA concentration [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma MDA 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.

  20. Secondary dependent variable: Circadian rhythm phase of plasma MDA concentration [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma MDA 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.

  21. Secondary dependent variable: Circadian rhythm amplitude of plasma MDA reactivity to exercise [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA 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.

  22. Secondary dependent variable: Circadian rhythm phase of plasma malondialdehyde (MDA) reactivity to exercise [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA 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.

  23. Secondary dependent variable: Circadian rhythm amplitude of plasma MDA concentration reactivity to change in posture [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA 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.

  24. Secondary dependent variable: Circadian rhythm phase of plasma malondialdehyde (MDA) reactivity to change in posture [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma MDA 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.

  25. Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane concentration [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of plasma 8-isoprostane 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.

  26. Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane concentration [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian phase of plasma 8-isoprostane 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.

  27. Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane reactivity to exercise [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane 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.

  28. Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane reactivity to exercise [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane 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.

  29. Secondary dependent variable: Circadian rhythm amplitude of plasma 8-isoprostane reactivity to change in posture [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane 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.

  30. Secondary dependent variable: Circadian rhythm phase of plasma 8-isoprostane reactivity to change in posture [ Time Frame: Over 5 days ]
    Comparisons will be made between participants with obstructive sleep apnea (OSA) and healthy controls of the circadian amplitude of change in plasma 8-isoprostane 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • BMI less than 40
  • Moderate to severe OSA (AHI)>15
  • No current or previous pharmacological treatment for hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202811


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Steven A Shea, PhD Oregon Health and Science University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Steven A. Shea, Dr. Steven A. Shea, PhD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02202811    
Other Study ID Numbers: OSA 00010101
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases